[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-syncytial-virus-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-syncytial-virus-infections":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,39,64,93,122,167,194,222,246,277,306,332,358,387,412],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100611039","evaluating-the-benefits-of-rsv-maternal-vaccination-using-a-scottish-national-dataset-100611039",false,"NCT07235397","Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset","Evaluating the Benefits Of RSV MaternaL vAccination Using a Scottish National Dataset.","BORLAND","Infants must meet all inclusion criteria to be eligible for inclusion in the study:\n\n1. Live birth in Scotland from 1st September 2024 to 28th February 2026\n2. Gestational age at birth ≥28(0\u002F7) weeks of gestation (earliest gestational age eligible for ABRYSVO vaccination)\n\nInfants meeting any of the following criteria will not be included in the study:\n\n1. Born to a mother who received any licensed or investigational RSV vaccine other than ABRYSVO at any time during pregnancy\n2. Meets UK national guidelines for monoclonal antibody receipt","ALL","0 Years","12 Months",{"count":21,"type":22},1,"ESTIMATED","OBSERVATIONAL","This study will use a retrospective cohort design and will be conducted within routinely collected national healthcare and statutory demographic datasets held by PHS and National Records of Scotland (NRS). As such, there will be no active enrollment of study participants, no direct contact with study participants, no collection of any primary data outside of the standard of care (SOC), and no requirement for informed consent.\n\nThis study design was chosen due to several advantages, over other possible designs, including the ability to evaluate incidence of study outcomes in exposed and unexposed infants, ability to follow infants longitudinally to evaluate study outcomes through 12 months of age, and ability to evaluate all-cause outcomes.\n\nStudy endpoints, including RSV-associated LRTD hospitalization and RSV-associated hospitalization, among infants born to ABRYSVO-vaccinated mothers (exposed group) will be compared with those among infants born to ABRYSVO-unvaccinated mothers (comparison group) initially from birth through 6 months of age, with later analysis from birth through 12 months as the infants reach this age threshold and their data become available.",[26],"Respiratory Syncytial Virus Infections","NOT_YET_RECRUITING","2026-06-29",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":33,"type":22},"2026-07-30",{"date":35,"type":22},"2026-11-13",{"name":37,"class":38},"Pfizer","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":21},"100544014","phase-3-human-interferon-1b-inhalation-solution-against-respiratory-syncytial-virus-in-children-with-lower-respiratory-tract-infections-100544014","NCT06363370","Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Human Interferon α1b Inhaled Solution in the Treatment of Respiratory Syncytial Virus Lower Respiratory Tract Infection in Children.","Inclusion Criteria:\n\n1. 2 months ≤ age ≤ 2 years of age (including the correction age of premature babies, after the correction of the monthly age = (Current Date-birth date)-\\[(37 weeks-fetal age)\u002F4\\], gender is not limited;\n2. Comply with the following diagnostic criteria:\n\n1\\) RSV real -time reversal transcript polymerase chain reaction (RT PCR) positive, or quantitative QPCR detection; Show the positive of RSV infection; 2) Cough and\u002For asthma, lung auspicious pitch and\u002For wet sounds; 3) Chest imaging examination shows the dot -shaped shadow and\u002For thick lung texture\u002Fslightly\u002Fmore and\u002For emphysema and\u002For the signs of inflammation around the bronchial.\n\n3\\. Signing the informed consent of the child's disease distance within 72 hours (cough, breathing, fever); 4. The severity of the condition of capillary bronchitis is moderate or severe; 5. The parents of the child, or the legal guardian, or the legal guardians have fully understood the relevant information of this experiment and the possible benefits and risks of the subject's expectations, and agreed that the child to participate in this experiment and voluntarily signed the informed consent.\n\nExclusion Criteria:\n\n1. There is a history of drug allergies (interferon products, related solutions formula components, etc.), or those with a history of specific allergies (asthma, based on the \"eczema area and severity index\" (EASI for short) scoring method as severe eczema, etc.), Or those who are diagnosed by doctors clearly diagnose (such as allergies to two or more drugs, food and pollen);\n2. Do not tolerate atomization inhalation to the administrator or suffer from severe oral and\u002For maxillofacial deformities, which affects the use of atomization inhalation;\n3. Those who have genetic metabolic diseases;\n4. A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen)；\n5. Any disabled drugs (disabled drugs include interferon, Libavarin and the drug instructions within 72 hours before the medication are expected to specify the Chinese medicines with antiviral effects, etc.) and within 24 hours before the administration of administration Children with sugar hormones used in inhalation and body;\n6. There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia.\n7. There is a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatitis, etc.;\n8. Those who are accompanied by basic diseases such as lung, bronchium, bronchial dysplasia;\n9. Candid's with functional disorders and lesions with epilepsy or other central nervous system, such as meningitis, toxic or hypoxic encephalopathy;\n10. During the filter, it is accompanied by severe diarrhea, moderate malnutrition, anemia, and blood system disease;\n11. During the screening, the thoracic effusion, pydion and pus, and pus, etc.;\n12. Merce able goose sores suspected mold infection during screening；\n13. The laboratory inspection is abnormal during screening:1) White blood cell count\\>14x109\u002FL (or normal value of normal value) or neutral granulocyte ratio\\> 70%, and researchers comprehensively judge suspects as merging bacterial infections;2) Excisibility of liver function test: Alanine aminotransferase (ALT) or permine aminamidase (AST)\\> The upper limit of the normal value is 2 times, or the total biliary erythrin\\> 1.5 times the upper limit of the normal value;3) Blood routine abnormalities: white blood cell count \\\u003C3.5X109\u002FL and\u002For platelet count≤100x109\u002FL；\n14. Extremely irritable, drowsiness, coma, or those who may need ventilator to assist breathing;\n15. After the history of the history of the disease, the child known (or the mother who is younger than 6 months old) is HIV -positive, or the researcher is highly suspected of being HIV -positive;\n16. In the random 30 days before the randomly participated in any drug clinical trial or those who used research drugs;\n17. Volunteers may not be able to complete this study or researchers who believe that they are not suitable for participating in this clinical trial due to various reasons.","2 Months","2 Years",{"count":49,"type":22},322,"INTERVENTIONAL",[52],"PHASE3","To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.",[26],"RECRUITING","2026-06-28",{"date":30,"type":31},{"date":59,"type":31},"2024-03-27",{"date":61,"type":22},"2027-06-30",{"name":63,"class":38},"Kexing Biopharm Co., Ltd.",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":50,"phases":74,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100609437","phase-2-a-study-of-s-337395-in-symptomatic-nonhospitalized-adults-with-respiratory-syncytial-virus-rsv-who-are-at-high-risk-of-progression-to-severe-disease-100609437","NCT07214571","A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease","A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus Who Are at High Risk of Progression to Severe Disease","Key Inclusion Criteria:\n\n* Participants who have new onset or worsening (if present chronically) of at least 1 of the following signs and\u002For symptoms consistent with a viral acute respiratory infection within 72 hours prior to randomization: fever, nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing.\n* Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay.\n* Has at least 1 of the following risk factors for severe RSV disease:\n\n  1. ≥ 75 years of age;\n  2. Chronic lung disease that is symptomatic and requiring chronic treatment; and\n  3. Chronic cardiovascular disease that is symptomatic and requiring chronic treatment.\n* With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening.\n\nKey Exclusion Criteria:\n\n* Hospitalized or expected to be hospitalized within 24 hours of screening.\n* Is considered by the investigator to be immunocompromised, due to an underlying medical condition or medical therapy, chemotherapy, radiation, stem cell or solid organ transplant.\n* Has known allergies, hypersensitivity, or intolerance to S-337395 or to any of the excipients of the S-337395 or placebo formulation.\n* Suspicion or known severe renal impairment.\n* Any other medical or psychiatric condition making the participant unsuitable for the current study or interfering with the evaluation of response to the study intervention in the opinion of the investigator\u002Fsubinvestigator.\n* Has received a therapy intended to treat RSV infection within 14 days prior to screening.\n* Is receiving chemotherapy or immunotherapy for malignancy.\n* Has received RSV vaccination within 7 days prior to screening.\n* Has had either confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza infection (test was positive) during the 28 days prior to screening.\n* Has any other confirmed clinically relevant respiratory infection by any pathogen at, or within 28 days of screening.\n\nNote: Other protocol-specified inclusion and exclusion criteria may apply.","18 Years",{"count":73,"type":22},192,[75],"PHASE2","The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention within 72 hours of RSV symptom onset.",[26],[26,79,80,81,82],"RSV infection","Viral infection","S-337395","Acute lower respiratory tract infection","2026-06-19",{"date":85,"type":31},"2026-06-23",{"date":87,"type":31},"2025-12-11",{"date":89,"type":22},"2026-12-30",{"name":91,"class":38},"Shionogi",77,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":50,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100642133","phase-2-a-study-of-ziresovir-ak0529-in-high-risk-adult-with-respiratory-syncytial-virus-rsv-infection-100642133","NCT07658534","A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.","A Randomized, Double-blind, Two-stage, Placebo-controlled Phase 2b\u002F3 Clinical Study to Evaluate the Efficacy and Safety of Ziresovir (AK0529) in Adult Patients at High Risk for Respiratory Syncytial Virus (RSV) Infection.","Inclusion Criteria:\n\n* Aged 18-85 years (inclusive), regardless of gender.\n* Diagnosed with RSV infection by antigen or nucleic acid test within 36 hours before first dose.\n* Have at least one of the following high-risk conditions for RSV infection: Chronic respiratory disease; heart disease; immunocompromised status; other chronic disease; age ≥65 years.\n* Presence of at least one new LRTD symptom or worsening of a pre-existing LRTD symptom (specifically: cough, expectoration, wheezing, shortness of breath), with at least one individual symptom rated as moderate or severe (score 2 or 3 per RiiQ Symptom Scale).\n* Time from symptom onset (or worsening of pre-existing symptoms) to first dose ≤5 days. (Onset defined as time of first RSV-related symptom\u002Fsign confirmed by investigator; pre-existing symptoms are those due to underlying conditions)\n\nExclusion Criteria:\n\n* Diagnosed with influenza or COVID-19 infection within 7 days prior to providing informed consent.\n* Suspected bacterial co-infection.\n* Received any potentially anti-RSV agents (e.g., ribavirin, long-acting interferon) within 5 half-lives prior to the first study dose, or plans to use such agents during the study.\n* Received prohibited medications, or plans to use prohibited medications during the study.\n* Has a severe or unstable gastrointestinal, hepatic, renal, hematologic disorder, or malignancy.\n* Has a known allergy, hypersensitivity, or intolerance to AK0529 or to any excipients in the AK0529 or placebo formulation.\n* Female participants with a positive pregnancy test result, or who are breastfeeding.\n* Refusal to use effective contraception during the trial period.","85 Years",{"count":102,"type":22},290,[75,52],"Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia, and affect the cardiovascular system, central nervous system and the renal system, resulting in hospitalization and death risks in children and also high-risk adults, particularly the elderly. The purpose of this study is to evaluate the efficacy of Ziresovir (AK0529) compared to placebo with respect to the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms.",[26],[107,108,109,110,111],"Ziresovir","RSV","Chronic Respiratory Disease","Heart Disease","The Elderly","2026-06-15",{"date":114,"type":31},"2026-06-22",{"date":116,"type":31},"2026-03-03",{"date":118,"type":22},"2029-01",{"name":120,"class":38},"Shanghai Ark Biopharmaceutical Co., Ltd.",9,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":50,"phases":131,"briefSummary":133,"conditions":134,"keywords":139,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100568680","phase-1-study-on-safety-and-efficacy-of-two-doses-of-prs-ck-storm-in-the-modulation-of-the-cytokine-storm-in-patients-with-acute-respiratory-infection-caused-by-sars-cov-2-influenza-a-influenza-b-and-respiratory-syncytial-virus-rsv-100568680","NCT06684379","Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)","Double-blind, Randomized, Placebo-controlled, Pilot Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Two Doses of a Conditioned Medium From a Co-culture of M2-macrophages and Fat-derived Mesenchymal Cells (PRS CK STORM) in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)","Inclusion Criteria:\n\n1. Signed informed consent by the participant or legal representative prior to the initiation of any study-specific procedure.\n2. Males and females aged ≥ 18 years old at the time of the consent.\n3. Confirmed diagnosis of SARS-CoV-2, influenza virus A, influenza virus B or RSV pneumonia by positive RT-PCR (results of a PCR prior to screening will be valid only if the PCR has been done for all 4 viruses and in 3 days prior to the screening visit). PCR will include the analysis of SARS-Cov-2, influenza A, influenza B and RSV.\n4. Diagnosis of systemic inflammatory response syndrome (SIRS), defined by the satisfaction of any two of the criteria below:\n\n   1. Body temperature over 38 ºC or under 36 ºC.\n   2. Heart rate greater than 90 beats\u002Fminute.\n   3. Respiratory rate higher than 20 breaths\u002Fmin or PaCO2 lower than 32 mmHg.\n   4. Leukocyte count higher than 12000\u002FμL, lower than 4000\u002FμL or over 10% immature forms or bands.\n5. Need for oxygen therapy.\n6. Female participants must be, either surgically sterilized or at least 1 year postmenopausal (confirmed by follicle-stimulating hormone \\[FSH\\] more than 20 international units \\[Ius\\] only for women under 54) or using adequate birth control (hormonal contraception, intrauterine contraceptive device, double barrier methods \\[condom with spermicide, diaphragm with spermicide, or condom and diaphragm\\]) or sexual abstinence for up to 90 days after the last treatment administration. Male participants must be willing to use barrier contraception (condom) for up to 90 days after the last treatment administration.\n\nExclusion Criteria:\n\n1. Failure to perform screening or baseline examinations.\n2. Body Mass Index (BMI) more than or equal to 35.\n3. Irreversible critical condition, as assessed by the investigator.\n4. Active autoimmune diseases or severe immunosuppression, unless stable and controlled for at least 3 months prior to the inclusion in the study.\n5. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the clinical assessment, such as:\n\n   1. Liver function test abnormalities or other signs of hepatic insufficiency not justified by a pulmonary acute inflammation process: Aspartate transaminase (AST), alanine transaminase (ALT) more than 3 per upper limit of the reference range, total bilirubin more than or equal to 2 mg\u002FdL; except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome.\n   2. Renal insufficiency (serum creatinine more than 2 mg\u002FdL (more than 150 μmol\u002FL) and creatinine clearance less than 30 (according to Cockcroft-Gault formula).\n   3. Myocardial infarction, unstable angina, heart failure within 3 months before screening.\n   4. Bradycardia (heartbeat less than 50\u002Fmin).\n   5. Atrioventricular block (type II \u002F Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF interval (males more than 450 msec and females more than 470 msec using Fridericia's formula: QTc = QT\u002F RR\\^2 ).\n   6. Uncontrolled diabetes mellitus (blood glucose level above 500 mg\u002FdL) at the time of admission.\n   7. Malignant tumors within the last 5 years, unless stable during that time. Skin malignancies (other than melanoma) and indolent prostate cancer are excluded from this criterion.\n   8. Metastases.\n   9. Human Immunodeficiency Virus (HIV), HBV \\[hepatitis B surface antigen (HBs Ag) positive (+), or detected sensitivity on the HBV deoxyribonucleic acid (DNA), polymerase chain reaction (PCR) qualitative test for hepatitis B core antibody (HBc Ab) positive subjects\\] or HCV \\[HCV ribonucleic acid (RNA) detectable in any subject with positive anti-HCV antibody (HCV Ab)\\].\n6. Inability to comply with the study and monitoring procedures.\n7. Pregnant and breastfeeding females (pregnancy test positive).\n8. Suspected or known active drug or alcohol abuse.\n9. Enrollment in another investigational drug study within 1 month before the screening\n10. Subject who has any condition, including any psychological or psychiatric condition, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.",{"count":130,"type":22},50,[132,75],"PHASE1","The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal Stromal Cells (PRS CK STORM) in the modulation of the cytokine storm in participants with acute respiratory infection caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV) in need for oxygen therapy.\n\nThe main questions it aims to answer are:\n\n* Are both doses of PRS CK STORM (dose A and dose B) safe as an intravenous drug to modulate inflammatory processes, such as the cytokine storm in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV?\n* Are both doses of PRS CK STORM (dose A and dose B) effective as an intravenous drug to modulate SIRS-associated cytokine storm caused by SARS-Cov-2, influenza A, influenza B and RSV compared to the control group?\n* What are the anti-inflammatory and pro-inflammatory cytokine profiles after treatment with two different doses of PRS CK STORM in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV?\n\nResearchers will compare both doses of PRS CK STORM with the control group to test whether the anti-inflammatory action of PRS CK STORM is safe and effective in modulating the cytokine storm for the treatment of SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV. In addition, the anti-inflammatory and pro-inflammatory cytokine profiles after treatment PRS CK STORM compared to placebo group in these participants will be also studied.",[135,136,26,137,138],"SARS-CoV-2","Influenza, Human","Respiratory Distress Syndrome","Systemic Inflammatory Response Syndrome",[140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,138],"SARS-CoV-2 infection","Causing atypical respiratory disease (COVID-19)","2019 Novel Coronavirus","COVID-19 Virus","SARS Coronavirus 2","COVID-19-associated cytokine storm","Lung Diseases","Pneumonia","M2-macrophages","Mesenchymal cells","Influenza A Virus","Influenza B Virus","RSV Infection","Acute Respiratory Distress Syndrome","ARDS, Human","Respiratory Distress Syndrome, Acute","Cytokine storm","2026-06-05",{"date":159,"type":31},"2026-06-10",{"date":161,"type":31},"2024-10-02",{"date":163,"type":22},"2026-10-02",{"name":165,"class":38},"PEACHES BIOTECH",3,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":17,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":50,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":5},"100489596","phase-1-a-study-of-blb-201-rsv-vaccine-in-infants-and-children-100489596","NCT05655182","A Study of BLB-201 RSV Vaccine in Infants and Children","A Phase 1\u002F2a Trial of the Safety, Tolerability and Immunogenicity of PIV5-vectored RSV Vaccine (BLB-201) in RSV Seronegative and Seropositive Infants and Children","Inclusion criteria for sero+ children 18 to 59 months of age enrolled in Groups 1 and 2:\n\nHealthy children at least 18 months but less than 60 months of age whose legally-acceptable representative (LAR) understands and signs the trial informed consent and agrees to vaccine administration following a detailed explanation of the trial.\n\nDetermined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.\n\nSero+ for RSV as defined by serum RSV antibody titer assay\n\nParticipant is expected to be available for the duration of the trial.\n\nThe LAR confirms that the subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.\n\nGrowing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND has a current height and weight above the 3rd percentile for age.\n\nInclusion criteria for sero+ or sero- infants and children 8 to 24 months of age enrolled in Groups 3 through 6:\n\nHealthy children at least 8 months but less than 25 months of age whose LAR understands and signs the trial informed consent and agrees to vaccine administration following a detailed explanation of the trial.\n\nDetermined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.\n\nSero- OR sero+ for RSV antibody, defined by serum RSV antibody titer assay not more than 30 days prior to vaccination.\n\nParticipant is expected to be available for the duration of the trial.\n\nThe LAR confirms that subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.\n\nGrowing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND\n\nIf \\\u003C1 year of age: has a current height and weight above the 5th percentile for age.\n\nIf ≥1 year of age: has a current height and weight above the 3rd percentile for age.\n\nSubject Exclusion Criteria\n\n\\\u003C8 months of age and \\>60 months of age at the time of planned vaccine inoculation.\n\nBorn at less than 34 weeks gestation for subjects ≥ 1 year of age at enrollment\n\nBorn at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age.\n\nMaternal history of a positive HIV test before or during pregnancy.\n\nMaternal history of illicit drug abuse or alcohol abuse.\n\nEvidence of chronic disease except for chronic diseases that are mild, stable and not immune compromising or require recent change (\\\u003C 60 days) in management (e.g., mild stable eczema, mild allergic rhinitis)\n\nClinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by medical history or physical exam. Abnormal pulse oximetry testing during screening for undetected critical congenital heart disease or concern for such by medical history or physical exam.\n\nAcute or chronic medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.\n\nHistory of severe infection (e.g., requiring hospitalization).\n\nKnown or suspected impairment of immunological functions, bone marrow\u002Fsolid organ transplant recipients.\n\nReceiving immunosuppressive therapy including systemic corticosteroids.\n\nMajor congenital malformations, including congenital cleft palate or cytogenetic abnormalities.\n\nSuspected or documented developmental disorder, delay, or other developmental problem.\n\nCardiac abnormality requiring treatment. Participants with clinically insignificant cardiac abnormalities (e.g., clinically insignificant patent foramen ovale) requiring no treatment may be enrolled.\n\nLung disease or reactive airway disease.\n\nHistory of wheezing episode\u002Fs or receipt of bronchodilator therapy\n\nPrevious receipt of supplemental oxygen therapy in a home setting.\n\nHistory of severe RSV infection or severe respiratory virus infection (e.g., requiring hospitalization).\n\nPrevious immunization with an investigational RSV vaccine.\n\nPrevious or planned administration of any anti-RSV antibody product within 6 months of receipt of study vaccine.\n\nPrevious receipt of immunoglobulin or any other antibody products within the past 6 months.\n\nPrevious receipt of any blood products within the past 6 months.\n\nPrevious anaphylactic reaction.\n\nPrevious serious vaccine-associated adverse reaction or one that was Grade 3 or above.\n\nKnown hypersensitivity to any study vaccine product component.\n\nHousehold contact with any of the following groups of individuals for the period up to 28 days after vaccination (including after each dose for cohorts receiving two doses of vaccine):\n\nMember of a household that contains an infant who is less than 6 months of age at the date of inoculation through the 28th day after inoculation. In groups assigned to two doses of vaccine, to include date of inoculation through the 28th day after the second inoculation.\n\nPregnant woman.\n\nPersons with hospitalization for asthma or other chronic respiratory disease in the past 5 years.\n\nMember of a household that, at the date of inoculation through the 28th day after inoculation (including second dose if scheduled), contains an immunocompromised individual including but not limited to:\n\nA person who is HIV-infected.\n\nA person who has cancer and has received chemotherapy within the 12 months prior to enrollment.\n\nA person with a solid organ or bone marrow transplant.\n\nA person currently receiving immunosuppressive agents.\n\nAttends a daycare facility that does not separate children by age and contains an infant\n\n\\\u003C6 months of age at the date of inoculation through the 28th day after inoculation.\n\nNeurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).\n\nHistory of postinfectious or postvaccine neurological sequelae.\n\nAutoimmune, inflammatory, vascular, or rheumatic disease.\n\nHousehold contact of another child enrolled into the trial.\n\nInadequate venous access for repeated phlebotomy.\n\nSubject's LAR\u002Fs who, in the opinion of the site investigator, are not suitable participants for the study, for any reason not previously delineated, including subjects with any condition that would in the opinion of the site investigator place the subject at unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.\n\nSubjects testing positive for infection with RSV, Influenza, or SARS-CoV-2 in the 3 months prior to enrollment.\n\nPlanned receipt of any of the following prior to planned trial vaccine receipt (Day 1 and Day 57 for group receiving 2 doses of vaccine):\n\nInactivated influenza vaccine within 14 days prior, or\n\nAny other inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or\n\nAny live vaccine, other than rotavirus vaccine, within the 28 days prior, or\n\nAnother investigational vaccine or investigational drug within 28 days prior.\n\nSalicylate (aspirin) or salicylate-containing products within 28 days prior.\n\nPlanned receipt of any of the following after planned trial vaccine receipt (Day 1 and Day 57 for groups receiving 2 doses of vaccine):\n\nInactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or\n\nAny live vaccine other than rotavirus in the 28 days after, or\n\nAnother investigational vaccine or investigational drug in the 56 days after.\n\nPlanned receipt of any of the following medications within 7 days of trial enrollment and 7 days after trial vaccine (Day 1 and also Day 57 for groups receiving 2 doses of vaccine):\n\nSystemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or systemic or nasal steroid therapy for acute illness.\n\nAny other intranasal medications, or\n\nOther prescription medications except permitted concomitant medications. Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents.\n\nHistory of bleeding disorder or significant problem with bleeding\n\nAmerican Indian or Alaska Native Infants\u002FChildren (high risk for severe RSV infection) AND eligible to receive nirsevimab\n\nTemporary exclusion criteria for sero+ children, sero- children, and infants:\n\nThe following are temporary or self-limiting conditions, and once resolved, the subject may be enrolled, if otherwise eligible. If the period of temporary exclusion is greater than 30 days, sero- children will need to be rescreened for levels of RSV neutralizing antibody.\n\nAny of the following events at the time of enrollment:\n\nFever (temperature of ≥100.4°F per site standard based on age; e.g., oral for older children, rectal for infants, axillary screening), or\n\nUpper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or\n\nNasal congestion significant enough to interfere with successful vaccination.\n\nOtitis media.\n\nContact with a person diagnosed with RSV, Influenza, coronavirus disease-2 (COVID- 19) or other viral respiratory illnesses within the preceding 10 days.",true,"6 Months","5 Years",{"count":178,"type":22},137,[132,75],"This Phase 1\u002F2a trial is a randomized, placebo-controlled trial to evaluate the safety, tolerability and immunogenicity of two ascending doses (10\\^6 PFU and 10\\^7 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type 5) administered in infants (8-24 months of age) and children (18-59 months of age) who may or may not have had prior respiratory syncytial virus (RSV) infection.",[26],[183,184],"Human respiratory syncytial virus (RSV)","Lower respiratory tract infection (LRTI)","2026-06-01",{"date":187,"type":31},"2026-06-03",{"date":189,"type":31},"2023-03-09",{"date":191,"type":22},"2028-12-30",{"name":193,"class":38},"Blue Lake Biotechnology Inc.",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":50,"phases":204,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":5},"100609863","phase-3-a-study-on-the-immune-response-and-safety-of-vaccine-against-respiratory-syncytial-virus-given-to-chinese-adults-18-to-59-years-of-age-at-increased-risk-of-respiratory-syncytial-virus-disease-100609863","NCT07220109","A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease","A Phase 3, Randomized, Controlled, Observer Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Chinese Adults 18-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease","Inclusion Criteria:\n\n* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.\n* A male or female participant 18-59 YOA at the time of the study intervention administration.\n* Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable\\* by the investigator:\n\n  * A stable condition is defined as a disease not requiring significant change (based on the investigator's opinion) in therapy or worsening during the 3 months before enrollment.\n\n    -Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long-term medication: oChronic obstructive pulmonary disease (COPD)\n* Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade 2-4 oAsthma\n* Patient on Maintenance and Reliever Therapy (MART) OR with at least one rescue treatment per week (excluding exercise asthma) oCystic fibrosis oOther chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis oChronic heart failure:\n* A minimum of class II symptoms according to New York Heart Association classification of heart failure oPre-existing CAD (CAD not otherwise specified)\n* Physician diagnosis of CAD based on electrocardiogram, exercise stress test, nuclear stress test, cardiac computed tomography scan or cardiac angiogram (more than the presence of hypercholesterolemia) oCardiac arrhythmia\n* Patient diagnosed with a cardiac arrythmia that require medical support either pharmacologically or with a medical device -Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months\n\n  -Other diseases at increased risk for RSV disease oChronic kidney disease\n* G2-G3 disease (Glomerular Filtration Rate between 30 and 90 mL\u002Fmin\u002F1.73 m2) oChronic moderate to severe liver disease\n* Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as premenarche, hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.\n* Female participants of childbearing potential may be enrolled in the study, if the participant:\n\n  * has practiced adequate contraception from 1 month prior to study intervention administration, and\n  * has a negative pregnancy test on the day of study prior to intervention administration, and\n  * has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration.\n\nExclusion Criteria:\n\nMedical conditions\n\n* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive\u002Fcytotoxic therapy, based on medical history and physical examination.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention\n* Unstable chronic illness.\n* Any history of dementia or any medical condition that moderately or severely impairs cognition.\n* Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Study participants may decide to assign a caregiver to help them complete the study procedures.\n* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.\n* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.\n* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n\nPrior\u002FConcomitant therapy\n\n•Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Contact, Month 6).\n\n* Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.\n* Previous vaccination with any RSV vaccine, including investigational RSV vaccines.\n* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and\u002For administration of long-acting immune-modifying treatments or planned administration at any time up to the EOS.\n\n  * Up to 3 months prior to the study intervention administration:\n\noFor corticosteroids, this will mean prednisone \\>=20 mg\u002Fday, or equivalent. Inhaled, topical and intra-articular steroids are allowed oAdministration of immunoglobulins and\u002For any blood products or plasma derivatives -Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy, monoclonal antibodies, antitumoral medication.\n\nPrior\u002FConcurrent clinical study experience\n\n•Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine\u002Fproduct (drug or invasive medical device).\n\nOther exclusion criteria\n\n* History of chronic alcohol consumption and\u002For drug abuse as deemed by the investigator to render the potential participant unable\u002Funlikely to provide accurate safety reports or comply with study procedures.\n* Bedridden participants.\n* Planned move during the study conduct that prohibits participation until study end.\n* Participation of any study personnel or their immediate dependents, family, or household members.\n* Pregnant or lactating female participant.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.","59 Years",{"count":203,"type":22},750,[52],"The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.",[26],[208,209,210,211,212],"Respiratory syncytial virus (RSV)","Immunogenicity","Safety","Reactogenicity","Older adults at increased risk (OA AIR)","2026-05-25",{"date":215,"type":31},"2026-05-27",{"date":217,"type":31},"2025-10-29",{"date":219,"type":22},"2027-03-12",{"name":221,"class":38},"GlaxoSmithKline",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":174,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":50,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":21},"100640954","phase-1-clinical-trial-of-recombinant-rsv-vaccine-cho-cell-adjuvanted-in-chinese-population-aged-18-years-and-older-100640954","NCT07582796","Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.","A Randomized, Blinded, Controlled Phase I\u002FII Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) (Adjuvanted) in Adults Aged 18 Years and Older.","Inclusion Criteria:\n\n* Males or females aged 18 years and older at the time of enrollment (aged 18 years and older for the phase I part; aged 60 years and older for the phase II part), who are able to provide legal proof of identity.\n* Voluntarily agree to participate in the trial, able to fully understand and sign the informed consent form.\n* Able to attend all scheduled follow-up visits and comply with the requirements of the clinical trial protocol to complete the study.\n* Female participants must meet the following criteria: In the phase I part, women of childbearing potential\\* must have a negative pregnancy test prior to enrollment and be willing to use effective contraceptive measures for 12 months after receiving the investigational vaccine; in the phase II part, only women of non-childbearing potential will be enrolled.\n\n  * Women of childbearing potential: Defined as females who have experienced menarche and have not yet entered menopause, unless permanently sterile, such as documented bilateral salpingectomy, bilateral oophorectomy, or hysterectomy; menopause is defined as amenorrhea for 12 consecutive months without other medical cause.\n\n\\[Effective contraceptive measures include: oral contraceptives, injectable contraceptives, subdermal implants or hormonal patches, intrauterine device (IUD), sterilization surgery, abstinence (no sexual intercourse), male condoms, etc.; rhythm method, withdrawal, and emergency contraception are not considered effective contraceptive measures.\\]\n\n* Axillary body temperature ≤ 37.0°C measured on site prior to vaccination on the day of vaccination.\n\nExclusion Criteria:\n\n* Clinically significant laboratory abnormalities that, in the investigator's comprehensive judgment, preclude enrollment (applicable only to the phase I part).\n* Pregnant or breastfeeding women.\n* A clear diagnosis of RSV infection or a history of RSV infection-related respiratory disease within 6 months prior to vaccination.\n* Use of immunoglobulins or\u002Fand any blood products or plasma derivatives within 3 months prior to vaccination, or planned use during the study.\n* Treatment with immunomodulators (including immunosuppressants and immunostimulants) within 6 months prior to vaccination (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2 mg\u002Fkg\u002Fday or ≥20 mg\u002Fday prednisone or equivalent) (excluding inhaled, intra-articular, and topical steroids).\n* Administration or planned use of long-acting immunomodulatory drugs (e.g., infliximab) at any time during the study.\n* A history of severe allergic reactions (e.g., anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, Arthus reaction) following any previous vaccination or drug use, or a family history of severe allergies.\n* Impaired immune function or a diagnosis of congenital or acquired immunodeficiency, or human immunodeficiency virus (HIV) infection.\n* A personal or family history of convulsions, epilepsy, encephalopathy, psychiatric disorders, or neurological diseases (such as Guillain-Barré syndrome, Miller Fisher syndrome).\n* A diagnosis of lymphoproliferative disease or malignant tumor within 5 years.\n* Clinically significant electrocardiogram (ECG) abnormalities as determined by the investigator (applicable only to the phase I part).\n* Previous vaccination with any licensed or investigational RSV vaccine prior to enrollment, or planned vaccination during the study.\n* Receipt of any vaccine within 14 days prior to vaccination, or any live vaccine within 30 days prior to vaccination.\n* An acute disease or an acute exacerbation of a chronic disease within 3 days prior to vaccination, or use of antipyretic, analgesic, or anti-allergy medications.\n* Suspected or known alcohol abuse or alcohol dependence (referring to a drinking pattern that causes serious mental or physical health problems) or drug abuse.\n* A history of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection.\n* Severe or unstable chronic diseases, including but not limited to cardiovascular diseases \\[e.g., hypertension uncontrolled by medication (on-site blood pressure measurement prior to vaccination: systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg), coronary heart disease, myocarditis, pericarditis, atrial fibrillation\\], metabolic diseases (e.g., poorly controlled diabetes), hematological disorders (e.g., severe anemia, hemophilia), hepatic or renal diseases, digestive system diseases, respiratory system diseases (e.g., chronic obstructive pulmonary disease, active pulmonary tuberculosis, other severe respiratory diseases).\n\nNote: For participants aged 60 years and older, those with pre-existing stable disease may be enrolled. This is defined as participants who may have underlying conditions such as hypertension or diabetes, provided that symptoms and signs are stable and medically controllable as assessed by the investigator prior to vaccination, and who have not required changes to the treatment\u002Fmedication regimen or hospitalization due to the underlying condition within 3 months.\n\n* A history of confirmed immune-mediated\u002Fautoimmune diseases (e.g., cold agglutinin hemolytic anemia, lymphadenopathy, eosinophilia, systemic lupus erythematosus, gout, hyperuricemia, acute disseminated encephalomyelitis, immune thrombocytopenia, autoimmune aplastic anemia, autoimmune neutropenia, autoimmune lymphoproliferative syndrome, thrombocytopenic purpura).\n* Asplenia or functional asplenia, as well as any condition resulting in asplenia or splenectomy.\n* Currently participating in or planning to participate in another clinical study involving investigational or unregistered products (drugs, vaccines, medical devices, etc.) during this study.\n* Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in this clinical trial.",{"count":230,"type":22},470,[132,75],"The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. The primary objectives of the phase II trial are to evaluate the immunogenicity and safety of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) with different adjuvant ratios in adults aged 60 years and older, with the secondary objective being to evaluate the persistence of immune responses.",[26],[235,210,236,209],"Respiratory syncytial virus","RSV vaccine","2026-05-22",{"date":215,"type":31},{"date":240,"type":31},"2026-05-14",{"date":242,"type":22},"2029-08-14",{"name":244,"class":245},"Ab&B Bio-tech Co., Ltd.JS","OTHER",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":174,"sex":17,"minAge":71,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":50,"phases":256,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":4},"100538178","phase-1-a-study-to-describe-the-safety-and-immunogenicity-of-a-respiratory-syncytial-virus-vaccine-in006-in-healthy-adults-100538178","NCT06287450","A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Adult Participants","Key Inclusion Criteria:\n\n1. Healthy male or female participants aged ≥18 to 59 years of age (Part 1) or ≥ 60 to 79 years of age (Part 2).\n2. Body weight ≥ 50 kg for males and ≥ 45 kg for females and body mass index (BMI) in the range of 18.5 to 35 kg\u002Fm\\^2.\n3. For all women of childbearing potential (WOCBP) females must be non-pregnant and non-lactating and must use an appropriate contraceptive method from at least 30 days prior to study vaccination (an effective contraception) until at least 6 months after study vaccination. Women not of childbearing potential must be postmenopausal for ≥ 12 months.\n4. Male participants who are non-sterilized and sexually active must be willing to use an acceptable, effective contraceptive method from at least 30 days prior to study vaccination until at least 6 months after study vaccination.\n5. Able and willing to complete the study procedures during the entire study Follow-up period.\n6. Can understand the study procedures, voluntarily sign the informed consent form after informed consent, and be able to comply with the requirements of the clinical study protocol.\n\nKey Exclusion Criteria:\n\n1. Pregnant or lactating at Screening or prior to vaccination or planning to become pregnant (self or partner) at any time during the study, including the specified Follow-up period.\n2. Participants with a known (documented or self-reported) history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.\n3. Participants with a known (documented or self-reported) history of heart disease (eg, heart failure, recent coronary artery disease, myocarditis, pericarditis, cardiomyopathy, or atrial fibrillation). Note: chronic stable coronary artery disease that is considered mild may be allowed at the discretion of the Investigator.\n4. Participants with uncontrolled hypertension (supine systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg at Screening). Results at Screening may be confirmed by single repeat at the discretion of the Investigator.\n5. Participants with a Screening 12-lead ECG following at least 5 minutes of supine rest demonstrating a Fridericia corrected QT (QTcF) interval \\> 450 msec (for males) or \\> 470 msec (for females) or a QRS interval ≥ 120 msec.\n6. Participants with clinically significant abnormalities that indicate or meet the definition of a Grade 1 or greater abnormality for Part 1, or a Grade 2 or greater abnormality for Part 2 as delineated in the FDA guidance \"Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials\".\n7. Participants with acute medical or febrile illness (body temperature \\> 38.0°C or 100.4°F) within one day prior to vaccination.\n8. History of severe hypersensitivity reactions, including anaphylaxis or other significant adverse reactions to any components of a mRNA vaccine or known components of IN006.\n9. Received any live attenuated vaccines ≤ 28 days prior to vaccination or plans to receive any licensed vaccines within 28 days before the study vaccination, with the exception of licensed inactivated influenza vaccine or non-replicating influenza vaccine which may be given ≥ 14 days prior to the first study vaccination.\n10. Received immunomodulatory, immunostimulatory, or immunosuppressant drugs including interferon and cytotoxic drugs within 90 days of Screening or planning to receive during the study.\n11. Received a previous vaccination with any licensed or investigational RSV vaccine prior to enrollment or planned to receive at any time throughout the duration of the study.\n12. Received immunoglobulin and\u002For any blood products within 120 days of vaccination.\n13. Use of systemic corticosteroids exceeding the equivalent of 10 mg\u002Fday of prednisone for ≥ 10 days within 30 days of Screening or planning to receive during the study.\n14. History of a known bleeding disorder that would, in the opinion of the Investigator, contraindicate intramuscular (IM) injection.\n15. History of congenital or acquired immunodeficiency including HIV or immunosuppressive disorder, asplenia, or recurrent severe infections.\n16. Known or suspected clinically significant or unstable significant hematologic (including clotting disorders), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and untreated seasonal allergies) that may interfere with the study evaluations or the participants ability to complete the study, in the opinion of the Investigator.\n17. History of, or current positive results for, any of the following serological tests: HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV Ab), or syphilis.\n18. Recent history of major surgical procedures within 90 days of Screening.\n19. Treatment with an investigational product within 30 days, or 5 half-lives (whichever is longer) preceding vaccination.\n20. Blood donation of approximately 500 mL or more within 60 days prior to vaccination.\n21. Any other reason to be excluded in the opinion of the Investigator.","79 Years",{"count":255,"type":22},200,[132],"The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults.",[26],[260,261,235,262,263,264,265,266,267,210,211,209,108],"mRNA Vaccine","IN006","Viral Diseases","Messenger RNA","Innorna","Shenxin","Vaccines","Respiratory tract infections","2026-04-10",{"date":270,"type":31},"2026-04-13",{"date":272,"type":22},"2026-12",{"date":274,"type":22},"2028-04",{"name":276,"class":38},"Shenzhen Shenxin Biotechnology Co., Ltd",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":50,"phases":286,"briefSummary":287,"conditions":288,"keywords":289,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},"100600082","phase-2-a-study-evaluating-persistence-of-the-immune-response-of-the-adjuvanted-respiratory-syncytial-virus-rsv-vaccine-and-the-safety-and-immune-response-following-revaccination-in-adults-18-years-of-age-and-above-who-received-lung-or-kidney-transplant-100600082","NCT07092865","A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant","A Phase 2b, Non-randomized, Controlled, Open-label, Extension Study to Evaluate the Persistence of Immune Response of the Adjuvanted RSVPreF3 Vaccine and the Safety and Immunogenicity Following Revaccination in Lung and Kidney Transplant Recipients (>=18 Years of Age)","Inclusion Criteria:\n\n* Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for participants in IC\\_1 and Visit 4 for participants in IC\\_2 group), who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available.\n* Participants who, can and will comply with the requirements of the protocol (e.g., completion of the paper diary cards (as applicable), return for follow-up visits, ability to access and utilize a phone or other electronic communications, have regular contact to allow evaluation during the study).\n* Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.\n* Female participants of nonchildbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.\n* Female participants of childbearing potential may be enrolled in the study if the participant:\n* has practiced adequate contraception from 1 month prior to study intervention administration, and\n* agreed to continue adequate contraception until 1 month after study intervention, and\n* has a negative pregnancy test on the day of and prior to study intervention administration.\n* Participant who has received an ABO compatible allogeneic kidney or lung transplant (allograft) more than 12 months (365 days) prior to the study intervention administration.\n* Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.\n\nSpecific inclusion criteria for kidney transplant (KTx) patients\n\n• Participant with stable kidney function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history.\n\nSpecific inclusion criteria for lung transplant (LTx) patients • Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator.\n\nExclusion Criteria:\n\nMedical conditions\n\n* Any history of dementia or any medical condition that moderately or severely impairs cognition.\n* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival up to study end).\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention\n* Acute or chronic clinically significant cardiovascular or hepatic functional abnormality, as determined by physical examination or laboratory screening tests.\n* Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.\n* Any condition which, in the judgment of the investigator, would make IM injection unsafe.\n* Any other clinical condition that might pose additional risk to the participant due to participation in the clinical study.\n\nPrior\u002FConcomitant therapy\n\n* Vaccination with RSV-antigen containing vaccine after 1 or 2 doses received in the RSV OA=ADJ-023 study.\n* Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention administration during the period beginning 30 days before the study intervention administration (Day -30 to Day 1), or their planned use during the study period (up to Month 12).\n* Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study intervention administration and ending 30 days after the study intervention administration\\*. In the case of COVID-19 and inactivated\u002Fsubunit\u002Fsplit influenza vaccines, this time window can be decreased to 14 days before and after study intervention administration.\n\n  * If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and\u002For organized by the public health authorities outside the routine immunization program, the time period of 30 days described above can be reduced, if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified.\n\nPrior\u002FConcurrent clinical study experience\n\n• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug\u002Finvasive medical device).\n\nOther exclusion criteria\n\n* History of chronic alcohol consumption and\u002For drug abuse as deemed by the investigator to render the potential participant unable\u002Funlikely to provide accurate safety reports or comply with study procedures.\n* Any study personnel or their immediate dependents, family, or household members.\n* Planned move during the study period that will prohibit participating in the study until study end.\n* Pregnant or lactating female participant.\n* Female participant planning to become pregnant or planning to discontinue contraceptive precautions.\n* More than one organ transplanted (i.e., kidney-liver or kidney-other organ(s) transplanted). Dual organ is allowed (double kidney or double lung).\n* History of events that, in the opinion of the investigator, may put the participant at increased risk for chronic allograft dysfunction.\n* Participant with an episode of allograft rejection within 3 months (90 days) prior to Visit 1.\n* Histologic evidence of chronic allograft injury.\n* Active treatment for acute rejection.\n* Current diagnosis of malignancy (except non-melanoma skin cancer that does not require systemic therapy).\n* Any autoimmune conditions or pIMDs that in the opinion of the investigator may put the participant at increased risk.\n* Any confirmed or suspected HIV infection or primary immunodeficiency disease or ongoing CMV infection with a viremia \\> 200 IU\u002FmL.\n* Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and\u002For therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) prior to Visit 1.\n* Use of investigational and non-registered immunosuppressants at the local\u002Fcountry level, unless specifically prescribed for the prevention of allograft rejection, and which are non-registered and:\n* available locally through compassionate use programs,\n* submitted for and pending local\u002Fcountry registration,\n* approved and registered for use in other countries with well-documented SmPC or Prescribing Information. The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing.\n* Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and\u002For maintenance immunosuppressive therapies.\n* Any clinically significant (based on the Investigator's clinical judgement) hematologic (hemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, platelet red blood cell count and erythrocyte mean corpuscular volume) and\u002For biochemical (ALT, AST, creatinine, blood urea nitrogen) laboratory abnormality.\n\nSpecific exclusion criteria for KTx patients:\n\n* Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason for a previous allograft loss is not recurrent primary kidney disease.\n* Evidence of significant proteinuria\u002Falbuminuria in the opinion of the investigator.\n\nSpecific exclusion criteria for LTx patients:\n\n* At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks, based on the following: clinical, radiological, and\u002For physiological deterioration; OR isolation of an organism from a clinically relevant BAL fluid culture.\n* Patients with diagnosis of chronic lung allograft dysfunction, defined as a decrement of 20% or more in FEV1 compared to post-transplant baseline FEV1.",{"count":285,"type":22},184,[75],"This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.",[26],[290,291,292,293,294,295,296,210,211],"Respiratory Syncytial Virus (RSV)","Adjuvated RSVPreF3 vaccine","Solid organ transplant (SOT)","Kidney SOT","Lung SOT","Immunocompromised (IC) patients","Humoral immune response","2026-03-05",{"date":299,"type":31},"2026-03-06",{"date":301,"type":31},"2025-08-06",{"date":303,"type":22},"2027-07-16",{"name":221,"class":38},37,{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":312,"maxAge":47,"enrollmentInfo":313,"targetDuration":4,"studyType":50,"phases":315,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":5},"100441314","phase-3-azithromycin-treatment-for-respiratory-syncytial-virus-induced-respiratory-failure-in-children-100441314","NCT05026749","Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children","Inclusion criteria:\n\n* Admission to the pediatric ICU with a confirmed diagnosis of RSV infection. RSV infection is based on a positive nasal swab for RSV fluorescent antibody or via multiplex assay or culture;\n* Requiring intensive respiratory support defined as either mechanical ventilation or NIV (BiPAP or CPAP) or HFNC (at \\>1 L\u002Fkg\u002Fmin of flow\n* Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;\n* Onset of RSV-related symptoms must be less than 5 days\n* Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth.\n\nExclusion criteria:\n\n* AZM use within 7 days of ICU admission;\n* Contraindication to AZM use including known hypersensitivity to AZM, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic impairment (direct bilirubin \\>1.5 mg\u002FdL or ALT ≥ 10 times the upper limits of normal);\n* Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms);\n* Intensive respiratory support greater than 48 hours prior to ICU admission;\n* Chronic ventilation or supplemental oxygen need at home;\n* Immunosuppressive conditions such as those post heart or hematopoietic stem cell transplant or receiving chemotherapy and chronic steroids;\n* History of pyloric stenosis;\n* AZM is deemed necessary for clinical treatment (for instance, if patient has pertussis).","3 Days",{"count":314,"type":22},370,[52],"The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.",[26],[108,319,320,321,322],"AZM","ICU","Respiratory Support","Children","2026-02-04",{"date":325,"type":31},"2026-02-09",{"date":327,"type":31},"2022-02-27",{"date":329,"type":22},"2028-07-31",{"name":331,"class":245},"University of Alabama at Birmingham",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":339,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":4},"100614415","effectiveness-of-immunization-in-preventing-severe-acute-respiratory-infection-rsv-100614415","NCT07279298","Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV","Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection Associated With Respiratory Syncytial Virus-RSV- in Infants Under 6 Months of Age in Bogotá: a Case-control Study With a Negative Test Design","Inclusion Criteria:\n\n* Age: Infants younger than 6 months at the time of hospital admission.\n* Residence: Maternal residence in Bogotá, Colombia, verified through clinical record, identification document, or health system registry.\n* Clinical Condition: Hospitalization due to severe acute respiratory infection (SARI) meeting the district operational definition (presence of fever, cough, and\u002For signs of respiratory distress, requiring inpatient management).\n* Laboratory Testing: Respiratory specimen collected and tested for RSV by RT-PCR or validated antigen test within ≤48 hours of hospital admission, or repeated within 24-48 hours if initial test is negative.\n* Exposure Eligibility Window: Infant born ≥5 weeks after the start of the RSVpreF maternal vaccination campaign in Bogotá, ensuring opportunity for maternal immunization.\n\nExclusion Criteria:\n\n* Prematurity: Infants born at ≤32 weeks of gestation.\n* Healthcare-associated respiratory infection: Symptom onset \\>48 hours after hospital admission for another condition.\n* Non-respiratory hospital admission: Primary reason for hospitalization unrelated to respiratory disease (e.g., trauma, elective surgery).\n* Vaccination status unverifiable: Inability to confirm maternal RSVpreF vaccination status after reasonable attempts to verify through registry, vaccination card, or prenatal documentation.\n* Duplicate episodes: Readmission for the same respiratory episode ≤14 days after discharge (only the first episode will be included).\n* Delayed sampling: First respiratory sample obtained \\>48-72 hours after initial admission to the health system.\n* Lethal congenital conditions: Congenital or genetic disorders incompatible with life or that substantially alter the expected clinical course.\n* Concurrent interventional study participation: Enrollment in another clinical trial that may affect respiratory outcomes.\n* Inability to establish mother-infant linkage due to adoption, loss of parental custody, or absence of biological maternal records.","1 Day","180 Days",{"count":342,"type":22},1097,"This study aims to evaluate the real-world effectiveness of two preventive immunization strategies against Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection in infants less than six months of age in Bogotá, Colombia. The strategies include maternal vaccination with RSVpreF administered between 28 and 36 weeks of gestation and neonatal immunization with nirsevimab for infants born to mothers who did not receive RSVpreF during pregnancy. Using a test-negative case-control design embedded in the city's sentinel surveillance system, infants hospitalized for severe respiratory infection will be systematically tested for RSV. Comparative vaccine effectiveness will be estimated to determine the impact of maternal RSV vaccination and neonatal monoclonal antibody immunization on RSV-associated hospitalizations, intensive care admissions, and mortality. The study will generate real-world evidence to inform local and regional public health decisions and guide the implementation of cost-effective hybrid immunization strategies against RSV in middle-income settings.",[26,345,346,347],"Severe Acute Respiratory Infection","Bronchiolitis, Viral","Viral Respiratory Tract Infection","2025-12-01",{"date":350,"type":31},"2025-12-12",{"date":352,"type":22},"2026-02-01",{"date":354,"type":22},"2027-07-31",{"name":356,"class":357},"Bogotá District Health Secretariat","OTHER_GOV",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":17,"minAge":366,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":21},"100611361","genotype-and-disease-burden-of-rsv-in-older-vietnamese-adults-rsv-respiratory-syncytial-virus--100611361","NCT07239583","Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )","A Description of the Proportion, Genotype Distribution of Respiratory Syncytial Virus and the Severity of Disease in Hospitalized Elderly in Vietnam","RSV-VN-Elderly","Inclusion Criteria:\n\nTo be enrolled in the study, participants must meet all inclusion criteria:\n\n1. Individuals ≥ 60 years old at the time of screening (calculated from the date of birth to the date of screening)\n2. ARI or exacerbation of cardiopulmonary diseases diagnosed at the time of admission. ARI or ARI-compatible symptoms were defined as either:\n\n   * New onset or increase from baseline of: nasal congestion, rhinorrhea, sore throat, hoarseness, cough, sputum production, dyspnea, wheezing, hypoxemia, or\n   * Admitting diagnosis suggestive of ARI (e.g., pneumonia, upper respiratory infection, bronchitis, influenza, cough, viral respiratory illness, respiratory distress, or respiratory failure), or\n   * Admitting diagnosis was the exacerbation of an underlying cardiac or pulmonary disease involving acute respiratory symptoms within the previous 2 weeks (e.g., congestive heart failure \\[CHF\\], chronic obstructive pulmonary disease \\[COPD\\], or asthma exacerbation).\n3. The participant agrees to voluntarily participate in this study.\n\nExclusion Criteria:\n\nTo be enrolled in the study, participants must have none of the exclusion criteria:\n\n1. Symptom onset \\> 6 days prior to screening date\n2. Acute symptoms confirmed to be unrelated to infection or as assessed by the investigator\n3. Admission to any hospital within the 30 days preceding the screening date\n4. Previously enrolled in the study in the last 45 days","60 Years",{"count":368,"type":22},1000,"This observational, prospective, multicenter study aims to estimate the proportion of RSV infection in adults aged 60 years and older hospitalized due to acute respiratory infections or exacerbation of cardiopulmonary disease.",[371,26],"Respiratory Syncytial Virus Infection",[290,373,374,375,376,377],"Acute Respiratory Infection (ARI)","Metagenomic Sequencing (mNGS)","RSV Genotype","Disease Severity","Healthcare Resource Utilization","2025-11-16",{"date":380,"type":31},"2025-11-20",{"date":382,"type":31},"2025-10-06",{"date":384,"type":22},"2027-03-30",{"name":386,"class":245},"Tam Anh Research Institute",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":410,"locationsCount":21},"100531235","identification-and-clinical-validation-of-biomarkers-associated-with-clinical-severity-in-adults-infected-with-rsv-100531235","NCT06197152","Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With RSV","Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With Respiratory Syncytial Virus","ARF-RSV","Group of patients with RSV diagnosis\n\nInclusion Criteria:\n\n* Age \\> 18 years\n* Positive RSV RT-PCR in nasopharyngeal swab\n* Patient admitted to the hospital (intensive care unit or medical ward admission at inclusion) with clinical signs of lower respiratory tract infection (defined as the presence of two or more respiratory signes (cough, dyspnea, sputum production, wheezing, tachypnea (respiratory rate\\>20\u002Fmin) or one respiratory sign plus one or more systemic symptoms (fatigue and fever)) requiring hospitalization.\n* No objection letter (from the patient or a member of family if the patient is not physically able to give consent\n\nExclusion Criteria:\n\n* Co-infection with other respiratory viruses\n* Persons under guardianship\u002Fguardianship\n* AME (state medical aid) patient\n\nGroup of \"control\" patients\n\nInclusion Criteria :\n\n* Age\\>18 years\n* Patient's consent\n* Enrolled in a social security plan\n* Admitted for an acute respiratory syndrome\n* No diagnosis of respiratory infection in the 4 weeks prior to inclusion\n* Negative RSV nasopharyngeal PCR (or other respiratory specimen) collected within the last 48 hours\n* No immunosuppression (HIV infection, bone marrow or solid organ transplantation, post-chemotherapy aplasia, immunosuppressive therapy, corticosteroid therapy (\\> 200 mg\u002Fd hydrocortisone or equivalent within 4 weeks prior to inclusion)\n\nExclusion Criteria :\n\n* Persons under guardianship\u002Fguardianship\n* AME (state medical aid) patient",{"count":396,"type":22},133,"A short description, 5000 characters Intro: Respiratory Syncytial Virus (RSV) is a frequent, ubiquitous agent of respiratory viral infections. It is the leading viral cause of lower respiratory tract infection (LRTI) in infants and also causes significant morbidity and mortality in adults, especially in the elderly, in patients with cardiorespiratory comorbidities \\[e.g., patients with Chronic Obstructive Pulmonary Disease (COPD) and\u002For heart failure\\], and in immunocompromised patients. Clinical phenotyping of RSV respiratory infections has shown that the occurrence of LRTI in RSV-infected patients is associated with the need for ventilatory support and an increased risk of mortality. Virological data also suggest that there is a relationship between high nasopharyngeal viral replication levels and a poor prognosis, although these data have not been confirmed in other studies. Beyond viral load, the impact of viral subtypes on the severity of RSV infection is controversial. Few data have explored the prognostic value of genetic diversity (i.e., role of RSV variants, mutations occurring during clinical course) in RSV-infected adult patients with acute respiratory failure.\n\nObjective: The main goal of the present study is to identify and validate biomarkers associated with RSV severity in adults infected with RSV that will be useful to guide treatment decisions in the future. This study will additionally characterize the thus far unknown genetic diversity of RSV in hospitalized adults with severe and mild infections, in order to anticipate virological escape mechanisms from current and future treatments.\n\nMethod: This is a prospective multicenter cohort study of patients with RSV infection admitted to the hospital. These patients will be followed-up for 28 days. Nasopharyngeal samples will be obtained sequentially (i.e., at day 0, day 3-4, day 5-7, and day 14 of inclusion) for virological and transcriptomic analyses. Blood samples will also be collected at day 0 (EDTA tubes and Paxgene tubes) for peripheral transcriptomic analyses and plasma banking.\n\nThe 100 first patients included in the study will be allocated to the development cohort and the last 100 patients will be allocated to the validation cohort.",[26],[400,108,401,402,403],"Respiratory Syncytial Virus","Respiratory infection","Febrile acute respiratory syndrome","Immuno-virological determinants","2023-12-26",{"date":406,"type":31},"2024-01-09",{"date":408,"type":31},"2023-11-27",{"date":272,"type":22},{"name":411,"class":245},"Assistance Publique - Hôpitaux de Paris",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":174,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":419,"targetDuration":47,"studyType":23,"phases":4,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":4},"100440609","epidemiology-and-household-transmission-of-streptococcus-pneumoniae-and-respiratory-syncytial-virus-100440609","NCT05017519","Epidemiology and Household Transmission of Streptococcus Pneumoniae and Respiratory Syncytial Virus","Epidemiology and Transmission of Streptococcus Pneumoniae and Respiratory Syncytial Virus in Children and Elderly: a Household-based Prospective Cohort Study","Inclusion Criteria:\n\n* Indicator case: Babies under 5 months of age were born in Mackay Children's Hospital and had no acute respiratory infection-like symptoms that required medical intervention when they agreed to participate in the trial.\n* Family members: family members living with the Indicator case, including 2-5 years old siblings, parents and grandparents over 65 years old.\n* Willing to sign the informed consent form and agree to join the official LINE account to receive research tracking.\n\nExclusion Criteria:\n\n* Babies older than 5 months\n* Co-morbid medical conditions of the baby such as chronic lung disease, cyanotic congenital heart disease, neuromuscular disease and a primary immunodeficiency.\n* Family members who do not live with the Indicator case\n* Family with grandparents younger than 65 years old\n* Someone living with family members refuses to participate in the research.\n* Unwilling to sign informed consent form or refuse to join the official LINE account to receive tracking.",{"count":420,"type":22},240,"This household-based prospective cohort study aims to stablish the household transmission of Respiratory syncytial virus and S. pneumoniae especially in the elderly and infants\u002Fchildren as well as inter-relationship between S. pneumoniae and Respiratory syncytial virus.",[423,26],"Streptococcus Pneumoniae Infection",[425,400,426],"Streptococcus Pneumoniae","household-based","2021-08-17",{"date":429,"type":31},"2021-08-24",{"date":431,"type":22},"2021-10-01",{"date":433,"type":22},"2026-07-31",{"name":435,"class":245},"Mackay Memorial Hospital"]