[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rsv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rsv":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,49,78,109,134,166,186,216,240,260,284],{"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":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100600401","phase-4-concurrent-versus-sequential-administration-of-tdap-and-rsv-vaccines-in-pregnancy-100600401",false,"NCT07097012","Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy","Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy - A Pilot Feasibility Trial","CosTaR","Inclusion Criteria\n\n1. Healthy pregnant individuals with a singleton pregnancy aged 18-49 years.\n2. Gestational age 28-29+6 WG at time of study screening, enrolment and randomization as per documented first trimester (less than or equal to13+6 WG) ultrasound, or the first date of last menstrual period if ultrasound not obtained in the first trimester, or the age of the embryo and the date of transfer if pregnancy resulted from assisted reproductive technology.\n3. Able to comply with the study procedures required to achieve primary objective of this pilot trial (not being able to comply with procedures required to achieve exploratory objectives is not an exclusion criteria).\n4. Informed consent read, understood and signed prior to study-specific procedures.\n\nExclusion Criteria\n\nAny of the following:\n\n1. Receipt of RSV vaccine anytime.\n2. Receipt of immunoglobulins (except Rho D) within 1 year prior to vaccination.\n3. Documented receipt of pertussis vaccine within 2 years prior to vaccination.\n4. Documented pertussis infection (by culture or polymerase chain reaction) within 2 years prior to vaccination.\n5. Receipt of blood transfusion products within 6 months prior to vaccination.\n6. Primary or secondary immunologic disorder or immunosuppression.\n7. Any conditions that, in the investigator's judgement, may interfere with subject's ability to comply with study procedures or receipt of prenatal care, such as behavioural or cognitive impairment or neuropsychiatric illness.\n8. Preconception diabetes mellitus (defined as: previous diagnosis of diabetes while not pregnant OR First trimester hemoglobin A1c level of 6.5% \\[47.5 mmol\u002Fmol\\] OR First trimester fasting blood glucose 126 mg\u002FdL \\[7 mmol\u002FL\\]).\n9. Preconception chronic hypertension (defined as: sustained elevation in the systolic blood pressure to ≥140 mmHg or the diastolic blood pressure to ≥90 mmHg, that is diagnosed either prior to pregnancy or prior to 20 WG).\n10. Congenital anomalies per ultrasound.\n11. Hepatitis B infection; Hepatitis C infection; Untreated syphilis.\n12. Contraindication to receipt of Tdap (BOOSTRIX, GSK): a) Hypersensitivity to any component of the Tdap (BOOSTRIX, GSK) vaccine or individuals having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, or pertussis vaccines; b) Encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis containing vaccine; c) Transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and\u002For tetanus.\n13. Contraindication to receipt of RSVpreF (ABRYSVOTM, Pfizer): Hypersensitivity to the active substance or to any component of the vaccine.\n14. Pregnancy complications at the time of recruitment that are risk factors for preterm delivery:\n\n    1. Gestational hypertension (defined as new onset hypertension after 20 WG of systolic blood pressure is ≥140 mmHg or the diastolic blood pressure is ≥90 mmHg on two measurements at a minimum of one hour apart);\n    2. Pre-eclampsia (defined as development of gestational hypertension \\[as defined in #a above\\] and proteinuria after 20 WG (Proteinuria defined as ≥300 mg in a 24 h urine specimen, or ≥0.30 on a spot protein: creatinine ratio, or ≥1+ on a dipstick;\n    3. Gestational diabetes mellitus uncontrolled at time of consent (gestational diabetes is defined as a clinical syndrome characterized by the absence of preconception diabetes mellitus \\[as defined in #8 above\\] AND identification of sustained hyperglycemia during pregnancy not due to other known causes (i.e. corticosteroids, beta-mimetics, etc.) based on positive internationally recognized oral glucose tolerance test OR fasting plasma glucose of 92-125 mg\u002FdL \\[5.1-6.9 mmol\u002Fl\\] using venous or capillary blood samples;\n    4. Fetal growth restriction (defined as estimated fetal weight below 10% using locally-accepted growth curve AND Absent or reversed end-diastolic flow of the umbilical artery Doppler OR Oligohydramnios \\[defined as a decreased amniotic fluid volume as defined by amniotic fluid index less than 8 cm or deepest vertical pocket less than 2 cm in the presence of intact membranes without concern for fetal anomalies contributing to its etiology\\]);\n    5. Placenta anomalies (placenta previa and abruptio, vasa previa);\n    6. Polyhydramnios (defined as abnormal increase in the volume of amniotic fluid as either a deepest vertical pocket of ≥8 cm or an amniotic fluid index of ≥24 cm);\n    7. Oligohydramnios (decreased amniotic fluid volume as defined in d above);\n    8. Short uterine cervix (\\\u003C25 mm in the second trimester of pregnancy);\n    9. A significant acute disease or oral temperature ≥38 Co within 24 hours prior to vaccination. Participants can return for evaluation to be randomized\u002Fvaccinated 72 hours after symptoms resolve, if they are still within 28-29+6 WG.","FEMALE","18 Years","49 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to learn if the RSV vaccine (protects against respiratory syncytial virus) and Tdap vaccine (protects against pertussis) are most effective in pregnant individuals when taken together at the same visit, or separately at different visits. This clinical trial will also learn about the safety and immune responses of these vaccines in pregnancy.\n\nThe Main question:\n\n-Is it possible to run a successful trial that tests how safe and effective it is to give Tdap and RSV vaccines in pregnancy either at the same time or one after the other, at different visits?\n\nThe Secondary question:\n\n-To determine how safe and how well the Tdap and RSV vaccines work when given in pregnancy either at the same time or one after the other, at different visits.\n\nThe Exploratory (optional participation) questions:\n\n* To measure the levels of antibodies against whooping cough (pertussis) and RSV in mothers at 7 and 19 months after giving birth, depending on whether they got the vaccines at the same time or one after the other during pregnancy.\n* To measure whooping cough antibody levels in the babies at 2, 7, and 19 months of age, whose mothers who received the vaccines in pregnancy.\n* To measure the levels of RSV antibodies in the mothers' breast milk at 1 week, 2 weeks, 4 weeks, and 2 months after giving birth.\n\nParticipants will be randomly assigned to Group 1 (vaccines given at the same time, same visit) or Group 2 (vaccines given one after the other, at different visits).\n\nThere are 4 visits as part of the main study, and 6 additional visits as part of the optional study (exploratory questions).\n\nVisit 1-2: Blood collection and vaccines administered Visit 3-4: Blood work (cord blood sample collection from infant, after delivery, if possible) Visit 5-8: Breast milk collection Visit 8-10: Blood collection (infant blood collection only at Visit 8).\n\nParticipants will be asked to keep a diary of symptoms throughout the study.",[28,29,30,31],"RSV","Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination","Pregnancy","Healthy",[28,33,30,34,35],"Tdap","Clinical trial","Vaccine","RECRUITING","2026-06-14",{"date":39,"type":40},"2026-06-16","ACTUAL",{"date":42,"type":40},"2025-10-16",{"date":44,"type":22},"2027-10",{"name":46,"class":47},"Canadian Immunization Research Network","NETWORK",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100632050","phase-4-rsv-vaccination-to-reduce-recurrent-aecopd-100632050","NCT07508644","RSV Vaccination to Reduce Recurrent AECOPD","Open-label, Multicenter Trial of RSV Vaccination to Reduce Moderate-to-severe Exacerbations in COPD Frequent Exacerbators: Clinical Effectiveness and RSV-specific Immune Responses","Inclusion Criteria:\n\n* Age 50 years or older\n* Spirometry evidence of airflow obstruction (post-bronchodilator FEV1\u002FFVC \\\u003C0.70)\n* Current or former smoker who had accrued a ≥10 pack-year smoking history\n* Frequent COPD exacerbator, as defined by at least ≥2 moderate or ≥1 severe AECOPD in the 12 months prior to screening \\[31,32\\]\n* On dual LABD (LABA and LAMA) using the same inhaler\u002Fdevice for ≥8 weeks\n* Up-to-date influenza and pneumococcal vaccination received at least 1 month prior to screening\n\nExclusion Criteria:\n\n* Coexisting significant pulmonary disease predominating the respiratory symptoms (e.g. asthma, bronchiectasis)\n* Life expectancy shorter than 1 year due to serious or unstable chronic illness (e.g. advanced lung cancer)\n* Refused to receive RSV vaccine (for the RSV group only)\n* Received RSV vaccine of any brand before\n* Immunocompromised or long-term steroid user (≥10mg\u002Fday prednisolone or equivalent for ≥2 weeks), which may affect the RSV vaccine efficacy\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine\n* Pregnant or lactating (females not yet menopausal must have a negative pregnancy test before receiving the RSV vaccination)\n* Unable to provide informed consent","ALL","50 Years",{"count":59,"type":22},320,[25],"Objectives: To determine whether respiratory syncytial virus (RSV) vaccination reduces the rate of all-cause moderate-to-severe acute exacerbations of COPD (AECOPD) in high-risk patients, and to characterise RSV-specific infection and immune responses in this population.\n\nHypothesis: RSV vaccination in COPD frequent exacerbators receiving dual long-acting bronchodilators will reduce all-cause moderate-to-severe AECOPD by at least 20-25% over 12 months.\n\nDesign and subjects: This multicentre, two-arm, open-label, prospective study will recruit 320 COPD patients with 2 moderate or severe AECOPD in the prior year despite dual long-acting bronchodilator therapy. Eligible subjects will be allocated 1:1 to receive RSV vaccination plus standard care or standard care alone and followed for 12 months.\n\nInterventions: Participants in the vaccine arm will receive a single dose of a licensed RSV vaccine in addition to usual COPD management. Controls will receive usual care without RSV vaccination during the study period.\n\nMain outcome measures: The primary outcome is the rate of all-cause moderate-to-severe AECOPD per patient-year. Secondary outcomes include RSV-positive AECOPD, RSV infection incidence confirmed by virological testing, severe AECOPD requiring hospitalisation, time to first moderate-to-severe AECOPD, and changes in plasma RSV-specific antibody titres over 12 months.\n\nData analysis and expected results: Exacerbation rates will be compared between groups using negative binomial regression with adjustment for key covariates on an intention-to-treat basis. The investigators expect RSV vaccination to achieve a clinically meaningful (20%) reduction in all-cause moderate-to-severe AECOPD and to provide mechanistic insights linking RSV immunity, RSV infection, and exacerbation risk in COPD frequent exacerbators.",[63,28],"COPD",[65,28,35],"AECOPD","NOT_YET_RECRUITING","2026-04-07",{"date":69,"type":40},"2026-04-13",{"date":71,"type":22},"2027-07-01",{"date":73,"type":22},"2030-12-31",{"name":75,"class":76},"Chinese University of Hong Kong","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":56,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100630052","phase-2-a-phase-2-study-to-investigate-the-efficacy-and-safety-of-zelicapavir-in-participants-aged-28-days-to-36-months-of-age-infected-with-respiratory-syncytial-virus-100630052","NCT07482657","A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus","Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zelicapavir in Participants ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus","Inclusion Criteria:\n\n* Participants diagnosed with RSV infection using an approved diagnostic assay, without known and\u002For documented coinfection with SARS-CoV-2 or influenza\n* Participant has signs of RSV infection with onset ≤3 days (72 hours) at the time of randomization\n* In the Investigator's opinion, the participant's caregiver understands and is able to comply with protocol requirements, instructions, and restrictions, and the participant is likely to complete the study as planned. The caregiver(s) should be of legal age.\n\nExclusion Criteria:\n\n* Participant has any condition that in the opinion of the Investigator would interfere with the evaluation of the study drug or participant safety.\n* Participant has underlying immune deficiency. Participants with immunoglobulin A deficiency are not excluded.\n* Participant has had major surgery within 6 weeks prior to randomization or has major surgery planned during the course of the study.\n* Participant is currently taking either chronically or has taken within 7 days prior to randomization, or is anticipated to receive during the course of the study, systemic medications that are known to cause immunosuppression other than corticosteroids for \\>5 days.\n* Participant has received an investigational agent within the last 30 days or 5 half-lives of the investigational agent, whichever is longer.","28 Days","36 Months",{"count":88,"type":22},150,[90],"PHASE2","Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and non-hospitalized children aged ≥28 days to ≤36 months who present with symptomatic RSV infection.",[93,28,94],"RSV Infection","Respiratory Syncytial Virus (RSV)",[28,96,97,98],"children","Respiratory Syncytial Virus","Pediatric study","2026-03-16",{"date":101,"type":40},"2026-03-19",{"date":103,"type":22},"2026-07",{"date":105,"type":22},"2026-12",{"name":107,"class":108},"Enanta Pharmaceuticals, Inc","INDUSTRY",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":77},"100625099","phase-1-study-to-evaluate-the-safety-of-a-lyophilized-rsv-mrna-vaccine-100625099","NCT07418229","Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine","A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety of Different Doses of a Lyophilized RSV mRNA Vaccine in Adults Aged 18 Years and Older","Inclusion Criteria:\n\n1. Participants can understand and voluntarily sign the informed consent form;\n2. Able to provide legal identity documents;\n3. Healthy individuals aged 18 years and above;\n4. Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures (such as correct use of condoms, or female participants using combined oral contraceptives, intrauterine devices) from the time the participant signs the informed consent form until 6 months after the administration of the investigational vaccine, and have no plans to donate sperm or ovums; Female participants of childbearing potential must also have adopted effective contraceptive measures within 2 weeks before enrollment.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from this trial:\n\n1. Those with fever on the day of vaccination with the trial vaccine, with an axillary temperature \\> 37.0℃ before vaccination;\n2. Those with a history of previous RSV vaccination, or a history of RSV infection within 6 months before enrollment.\n3. Known to be allergic to vaccines or vaccine components;\n4. Before vaccination, the electrocardiogram examination and clinical laboratory test indicators specified in the protocol are abnormal and clinically significant;\n5. Female participants who are breastfeeding or pregnant;\n6. Having autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, splenectomy, HIV infection);\n7. History of poorly controlled chronic diseases or severe diseases, including but not limited to cardiovascular diseases (such as hypertension uncontrolled by drugs, i.e., systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg for participants aged 18-59 years old, systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg for participants aged 60 years old and above, as well as congenital heart disease, atrial fibrillation, myocarditis, pericarditis), hematological system diseases, liver and kidney diseases, respiratory system diseases, malignant tumors, history of transplantation of major functional organs, or any other diseases or physiological conditions that the researcher believes can interfere with the trial results;\n8. Current encephalopathy (such as damage to cerebral nerve tissue caused by congenital hypoplasia of the brain, brain trauma, brain tumors, cerebral hemorrhage, brain infection, chemical drug poisoning, etc.);\n9. Severe neurological diseases, such as a history of demyelinating diseases including but not limited to Guillain-Barré syndrome, multiple sclerosis, neuromyelitis optica, acute disseminated encephalomyelitis, etc., or a history of convulsions, epilepsy, or a family history of mental illness;\n10. Having a doctor-diagnosed coagulation dysfunction (such as coagulation factor deficiency, coagulative diseases, abnormal platelets);\n11. Having received systemic immunosuppressive agents or other immunomodulatory treatments (prednisone \\[≥ 20 mg\u002Fday\\] or its equivalent) for ≥ 14 days within the past 3 months, cytotoxic therapy, or planning to receive such treatments during the study period;\n12. Having received immunoglobulin or other blood products within 3 months before receiving the trial vaccine, or planning to receive such treatments during the study period;\n13. Currently participating in other clinical trials, or planning to receive such drugs or vaccines during the study period;\n14. Having received live attenuated vaccines within the past 14 days or other vaccines with processes such as subunit or inactivated vaccines within 7 days;\n15. Having various acute diseases or acute exacerbation of chronic diseases within the past 7 days, or known or suspected active infection;\n16. Axillary temperature \\> 37.0℃ within the past 3 days, or use of anti-allergic drugs, non-steroidal antipyretic analgesics, etc.;\n17. Those with skin damage, inflammation, ulceration, rash, scarring, or other conditions at the target vaccination site that may interfere with vaccination or observation of local reactions;\n18. According to the researcher's judgment, participants have any other factors that make them unsuitable for participating in the clinical trial.",true,{"count":21,"type":22},[119],"PHASE1","To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years",[28,122],"mRNA Vaccine",[124],"RSV vaccine","2026-02-11",{"date":127,"type":40},"2026-02-18",{"date":129,"type":22},"2026-03-09",{"date":131,"type":22},"2027-05-30",{"name":133,"class":108},"Sinovac Biotech Co., Ltd",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":116,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":77},"100528389","clinical-outcomes-and-pharmacotherapy-effectiveness-in-the-va-health-care-system-cope-va-100528389","NCT06160128","Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)","CSP #2038 - COVID-19 Pharmacotherapy Effectiveness in the VA Healthcare System (COPE-VA)","COPE-VA","Inclusion Criteria:\n\nPhase 1:\n\n\\- Veterans aged 18 years with a laboratory-confirmed positive test for SARS-CoV-2 or a diagnosis of COVID-19 documented at any time since the beginning of the pandemic in January 2020 to present.\n\nPhase 2:\n\n* All Veterans aged 18 years alive and in VHA care as of January 2018.\n* Specific exclusion\u002Finclusion criteria and observation periods will be further defined for each sub-study (See outcomes\u002Fpublications).\n\nExclusion Criteria:\n\n* VA employees who are not enrollees",{"count":143,"type":22},400000,"OBSERVATIONAL","The purpose of this study is to comprehensively describe the temporal and geographic utilization of COVID-19 therapies used for mild to moderate disease during different periods of SARS-CoV-2 variant circulation as well as to compare demographic and clinical characteristics of Veterans who are treated or do not receive these different therapies. The investigators will also perform similar descriptive epidemiology for other respiratory viruses, including RSV and influenza and other infectious diseases. This first phase will critically inform feasibility and direction of the second phase, in which the investigators will use target trial emulation design to study the comparative effectiveness of therapies and vaccines for COVID-19, respiratory viruses, including RSV, and influenza, and other infectious diseases.",[147,28,148],"COVID-19, SARS-CoV-2 Infection","Influenza",[150,151,152,153,28,154,155],"COVID-19","pharmacotherapy effectiveness","SARS-CoV-2","antiviral","influenza","respiratory viruses","2026-02-05",{"date":158,"type":40},"2026-02-10",{"date":160,"type":40},"2022-09-26",{"date":162,"type":22},"2027-09-30",{"name":164,"class":165},"VA Office of Research and Development","FED",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":175,"studyType":144,"phases":4,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":77},"100617645","rsv-burden-in-hong-kong-100617645","NCT07321314","RSV Burden in Hong Kong","The Disease Burden of RSV Infection in Hong Kong","Inclusion Criteria:\n\n* Community-acquired respiratory tract infection symptoms\n* Age \\>= 18\n\nExclusion Criteria:\n\n* Unable to provide a good quality of sputum and saliva",{"count":174,"type":22},10000,"1 Month","RSV infection causes significant mortality and morbidity in susceptible adults. There are many publications on the global RSV disease burden in infants and young children but data on adults are lacking with lots of knowledge gaps. Currently there is no established effective antiviral therapy for RSV. RSV vaccines have recently become available commercially but the Center for Health Protection (Hong Kong) has yet to discuss procurement of RSV vaccines for the high risk groups. Thus a prospective study to assess the disease burden of RSV infection in adults would be of great interest.",[28],"2026-01-06",{"date":180,"type":40},"2026-01-08",{"date":182,"type":22},"2026-03-01",{"date":184,"type":22},"2028-08-31",{"name":75,"class":76},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":116,"sex":56,"minAge":4,"maxAge":4,"enrollmentInfo":194,"targetDuration":196,"studyType":144,"phases":4,"briefSummary":197,"conditions":198,"keywords":202,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100604284","preparedness-through-respiratory-virus-epidemiology-and-community-engagement-100604284","NCT07147517","Preparedness Through Respiratory Virus Epidemiology and Community Engagement","PREVENT: Preparedness Through Respiratory Virus Epidemiology and Community Engagement","PREVENT","Community Testing Component:\n\nInclusion:\n\n\\- All community members are able to participate in the community testing component.\n\nExclusion:\n\n\\- There is no exclusion criteria and participants will not be excluded based on pregnancy status or age.\n\nFor Component A:\n\nInclusion:\n\n* All ages\n* AND Lives in service area of a recruitment center (i.e., within range of courier pick up)\n* AND Plans to remain living in a recruitment area for the next 2 years.\n\nExclusion:\n\n* Inability to communicate in a language in which consent forms, materials, etc. are available\n* OR Incarcerated\n* OR Living in a congregate setting (e.g., assisted living, nursing home, university dormitories with shared bathroom and communal eating facilities)\n* OR Unable\u002Funwilling to participate in planned data and specimen collections\n* OR Unable to comply with study procedures, as determined by study investigators\n* OR Participation in clinical trials of investigational agents for respiratory viral infections during the three months prior to enrollment and for the duration of the study.\n\nFor Component B:\n\nInclusion:\n\nIndex case:\n\n* Detection of priority respiratory pathogen via laboratory or point-of-care test on the day of eligibility screening or in the previous 5 days, AND\n* Lives in service area of a recruitment center (i.e., within range of courier pick up), AND\n* Lives in a household with ≥1 other person and plans to remain in the household for at least the duration of specimen collection (i.e., 14 days), AND\n* Has not been hospitalized since the date of symptom onset.\n\nHousehold contacts:\n\n* Routinely sleep in the same household as index case and slept in household ≥1 night in the 7 days before index case symptom onset, AND\n* Plan to remain in the household for at least the duration of specimen collection (i.e., 14 days).\n\nHousehold:\n\n* There is ≥1 non-ill household member (i.e., asymptomatic and has not tested positive for the virus of the index case) on the day of eligibility screening or in the previous 5 days,\n* AND all symptomatic persons in the household had a symptom or diagnosis onset date on the day of eligibility screening or in the previous 5 days.\n\nExclusion:\n\nIndex case:\n\n* Lives in a congregate setting (e.g., assisted living, nursing home, university dormitories with shared bathroom and communal eating facilities)\n* Meet any A1 exclusion criteria\n\nHousehold contacts:\n\n* Has been hospitalized any time since date of primary case symptom onset\n* Meets any A1 exclusion criteria\n\nHousehold:\n\n* The enrollment visit occurs \\>6 days after the first symptom onset of primary case\n* The primary case in the household is not enrolled\n* The primary case has been hospitalized any time after the date of symptom onset",{"count":195,"type":22},25000,"5 Years","The CHARM network will be established through three primary institutions-Beth Israel Deaconess Medical Center (BIDMC), the University of California San Diego (UCSD), and the University of Washington (UW)-along with their subcontracting institutions. At UCSD and partner sites, the CHARM network will be implemented via the PREVENT project. All PREVENT participants will be consented in to Component A0 (Community Testing) and a subset of A0 participants will be invited to participate and will be consented into the other components: Component A (Ongoing Testing); Component A Sub-study (Immunology); Component B (Household Transmission).\n\nComponent A0 participants (Community testing) will be members of the community who are interested in accessing testing for respiratory infections and will be asked to provide limited information that will then be used for screening for study Components A and\u002For B.\n\nParticipants in Component A (Ongoing Testing ) will undergo weekly symptom screening. If they report symptoms, they will be asked to provide a nasal swab and complete illness questionnaires on the day they report symptoms (Day 0) and again on Days 7 and 14. Participants in Component A Sub-study (Immunology) will provide blood and saliva\u002Fnasal fluid samples twice a year, as well as before and after infection and\u002For immunization against priority pathogens.\n\nParticipants in Component B (Household Transmission) will complete daily symptom questionnaires and nasal swabs for 14 days following enrollment, regardless of symptoms. Those who are symptomatic at enrollment will also complete retrospective daily diaries from symptom onset to the enrollment date. Additionally, they provide blood and\u002For saliva\u002Fnasal fluid samples at enrollment and again 28 days later.\n\nFor all Components, UCSD will provide PCR test results for SARS-CoV-2, Influenza A\u002FB, and RSV for nasal swab samples.",[199,200,28,201],"Respiratory Infection Virus","COVID -19","FLU",[203,204,205],"respiratory pathogen testing","vending machine","implementation","2025-10-31",{"date":208,"type":40},"2025-11-04",{"date":210,"type":40},"2025-10-08",{"date":212,"type":22},"2030-10-30",{"name":214,"class":76},"University of California, San Diego",2,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":56,"minAge":4,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":77},"100609673","clinical-validation-of-the-aptitude-medical-systems-metrix-respiratory-panel-test-in-at-homenon-laboratory-settings-100609673","NCT07217639","Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home\u002FNon-Laboratory Settings","Inclusion Criteria:\n\n1. Participant or guardian understands and is able and willing to provide written informed consent, and assent where applicable, prior to study enrollment.\n2. Participant is currently exhibiting signs\u002Fsymptoms of respiratory tract infection including but not limited to fever, cough, sore throat, runny nose, myalgia, headache, chills, new loss of taste or smell, or fatigue. Participant must still be exhibiting symptoms on the day of specimen collection. Days post symptom onset is not to exceed 14 days.\n3. Participant or guardian agrees to read, and is able to read with understanding, the Quick Reference Instructions (QRI) prior to beginning the execution of each of the tests.\n4. Participant or guardian is able and willing to contribute the required swab specimens for testing and understands and is able and willing to sign the study informed consent.\n5. Participant is willing to provide all samples and run tests for the specified investigational devices.\n\nExclusion Criteria:\n\n1. Participant does not understand and\u002For is not able and willing to sign the study informed consent and\u002For assent.\n2. Participant or guardian is not able to comply with nasal swab collection requirements following the Quick Reference Instructions (QRI).\n3. Participant is not currently exhibiting respiratory tract infection symptoms.\n4. Participant has previously participated in the study.\n5. Participant is not able to tolerate specimen collection.\n6. Participant is currently undergoing or has within the past thirty (30) days undergone treatment with prescription medication to treat SARS-CoV-2 infection, including but not limited to Remdesivir (Veklury®), Nirmatrelvir\u002FRitonavir (Paxlovid®), Molnupiravir (LagevrioTM) or receiving convalescent plasma therapy for SARS-CoV- 2.\n7. Participant is currently undergoing or has within the past thirty (30) days undergone an inhaled influenza vaccine (FluMist®), or antiviral treatment, including but not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), Baloxavir Marboxil (Xofluza®), Amantadine (Symmetrel®), Rimantadine (Flumadine®), or Peramivir (Rapivab®).\n8. Participant is currently undergoing or has within the past thirty (30) days undergone antiviral treatment for RSV, including but not limited to Ribavirin (Virazole®), RSV-IGIV (RespiGam®), Palivizumab (Synagis®), or Nirsevimab-alip (Beyfortus®).\n9. Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.\n10. Participants who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.\n11. Participants who do not understand\u002Fread the English language.",{"count":223,"type":22},2000,[225],"NA","The Metrix Respiratory Panel Test will be evaluated for use in Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix Respiratory Panel Test for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory syncytial virus, and Rhinovirus in anterior nares (AN) swab samples. Additional sites may be added to the study in order to meet minimum subject\u002Fsample enrollment requirements and geographic prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus.",[200,228,229,230,28,231],"Influenza A","Influenza B","Respiratory Synctial Virus","Rhinovirus","2025-10-14",{"date":42,"type":40},{"date":235,"type":22},"2025-11-01",{"date":237,"type":22},"2026-09-01",{"name":239,"class":108},"Aptitude Medical Systems",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":215},"100595255","surveillance-assessment-and-detection-of-influenza-associated-respiratory-infections-in-hiv-positive-and-negative-individuals-in-lusaka-zambia-100595255","NCT07030075","SURVEILLANCE, ASSESSMENT AND DETECTION OF INFLUENZA ASSOCIATED RESPIRATORY INFECTIONS IN HIV POSITIVE AND NEGATIVE INDIVIDUALS IN LUSAKA, ZAMBIA","Inclusion Criteria:\n\n* i. age ≥18 years old ii. presenting with flu-like symptoms or acute respiratory infection with ≥2 to 7 days history of cough and \u002For sore throat and fever, +\u002F- sneezing, +\u002F- congestion, +\u002F- myalgia, +\u002F- fatigue, +\u002F- wheezing, shortness of breath)\\[55-57\\] iii. willing to share their HIV status or be tested iv. willing to share their COVID-19 vaccination status v. able and willing to give informed consent vi. willing to provide a nasal\u002F nasopharyngeal sample for testing as part of standard of care vii. willing to provide exhaled breath aerosol samples i.e. wear a mask and provide a breath sample viii. willing to fill a symptoms diary card for symptom tracking for 7 days ix. agree to be followed-up and attend study visits up to two weeks after study entry\n\nExclusion Criteria:\n\n* i. individuals who are unwilling to provide any reference standard samples such as the nasopharyngeal swabs ii. those with symptoms for \\>7 days, or iii. those unwilling or unable to provide informed consent",{"count":247,"type":22},594,"Background and rationale:The World Health Organisation (WHO), estimates influenza global deaths at 290,000 to 650,000 annually. Although influenza is mostly associated with upper respiratory tract infections (URTIs), its role in lower respiratory tract infections (LRTIs) and the associated poor clinical outcomes have been overlooked in sub-Saharan Africa. A study conducted in eight SSA countries estimated that 8.2% of cases and 2.8% of deaths from LRTIs were due to primary infection with influenza. Pneumonia and influenza-associated illness are responsible for 8.5% of respiratory deaths in Zambia. However, in routine practice, testing to distinguish between bacterial and viral etiology of RTIs is seldom done outside sentinel surveillance due to the high cost and lack of available testing options. This consequently underestimates viral RTIs in the population. It is particularly important to diagnose flu early on in vulnerable populations so that they receive timely and appropriate medical care. Although Zambia is a high HIV burden country with a prevalence of 11%, there is presently no study that has described the burden of influenza in the HIV positive population. This research study will address gaps in current scientific knowledge, providing key insights about the prevalence, circulating types, seasonality and associated clinical outcomes of influenza, RSV and SARS-CoV-2 infection in Zambia in the post COVID-19 era.\n\nObjectives Primary To determine the prevalence of influenza (A and\u002For B) infections in a high HIV burden setting in Lusaka, Zambia over one or more influenza seasons.\n\nSecondary\n\n1. To determine the prevalence of influenza co-infection with RSV and\u002For SARS-CoV-2\n2. To determine the clinical outcomes of influenza (A and\u002For B) infection among Zambian adults, with and without co-infection with RSV and COVID-19, by HIV and COVID-19 vaccination status.\n3. To evaluate the accuracy and yield of aerosol-based sampling for diagnosis of respiratory viruses (influenza, SARS-CoV-2, and RSV) compared to nasal\u002F nasopharyngeal swabs, for rapid diagnosis of infection among symptomatic individuals in Zambia.\n4. To evaluate the acceptability of exhaled breath aerosol (XBA) sampling for diagnosis and screening of respiratory infections of pandemic potential.\n\nStudy design and participants:\n\nPrimary objective and secondary objective 1:\n\nCross sectional surveillance study of individuals presenting with flu-like symptoms at two first level hospitals in Lusaka, Zambia. Recruitment of 594 participants will be done over the study period and participants will include both males and females presenting with 2-7 days of flu-like symptoms, able to provide informed consent, aged ≥18 years, with a known HIV status or willing to be tested, with a known COVID 19 vaccination status and available for symptom follow-up.\n\nSecondary objective 2:\n\nProspective follow up of participants enrolled in aim 1 for 14 days will be done to document clinical symptom progression and outcomes. Appropriate care will be provided to all participants within routine care services.\n\nSecondary objective 3 \\& 4:\n\nMixed methods approach. All patients enrolled under aim 1 will be requested to provide in addition to the routine nasopharyngeal sample, an aerosol-based sample for diagnostic accuracy and yield evaluation. We will also conduct an investigator-administered questionnaire to ascertain end-user experience and preferences for either sampling method.\n\nLocation Zambia (Kanyama and Chawama sub-districts) Duration April 2025 to November 2026 (Participant enrolment duration)",[148,28,250],"COVID - 19","2025-06-12",{"date":253,"type":40},"2025-06-19",{"date":255,"type":40},"2025-05-20",{"date":257,"type":22},"2027-01",{"name":259,"class":76},"Centre for Infectious Disease Research in Zambia",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":56,"minAge":4,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":283},"100567784","a-multi-site-clinical-evaluation-of-the-liaison-nes-flu-ab-rsv--covid-19-assay-in-symptomatic-patients-100567784","NCT06672692","A Multi-Site Clinical Evaluation of the LIAISON NES FLU A\u002FB, RSV & COVID-19 Assay in Symptomatic Patients","NES ABCR","Inclusion Criteria:\n\n* The specimen is a NPS or NS from a patient collected and preserved in 3 mL Universal Transport Media (UTM), BD Universal Viral Transport (UVT), or MicroTest M4RT transport media, or 1 mL Copan Eswab (Liquid Amies).\n* The specimen is from a patient who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.\n* The specimen is from a human patient with active signs and symptoms of respiratory tract infection at time of collection\n* Specimen stored at 2-8°C for up to 72 hours from collection. If there is a delay in testing, store specimen at ≤-70 °C.\n* The total volume of the leftover specimen received is ≥1.5 mL, except for specimens collected in Liquid Amies which requires a total leftover volume of ≥0.5 mL\n* The specimen was received in good condition (no leakage or drying of the specimen).\n\nExclusion Criteria:\n\n* Incorrect swab type\n* Incorrect transport media\n* Incorrect specimen handling (e.g. specimens not stored at recommended temperature)\n* The specimen has undergone more than two freeze\u002Fthaw cycles\n* Specimens collected with calcium alginate or organic swabs",{"count":268,"type":22},1000,[225],"The DiaSorin Molecular LIAISON® NES FLU A\u002FB, RSV \\& COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B, RSV and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors.\n\nThe LIAISON® NES FLU A\u002FB, RSV \\& COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B, RSV and SARS-CoV-2 infection in a professional laboratory setting.\n\nNegative results do not preclude influenza A, influenza B, RSV or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.",[272,229,28,273],"Influenza a","COVID 19","2024-11-01",{"date":276,"type":40},"2024-11-04",{"date":278,"type":40},"2024-09-30",{"date":280,"type":22},"2025-05",{"name":282,"class":108},"DiaSorin Molecular LLC",3,{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":56,"minAge":4,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":77},"100555407","effectiveness-and-impact-of-nirsevimab-in-chile-nirse-cl-100555407","NCT06511687","Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)","Effectiveness And Impact of Nirsevimab In A Nationwide Immunization Program During The 2024 Winter Campaign In Chile (Nirse-CL)","Inclusion Criteria:\n\n* Subjects born between October 1st, 2023, to September 31st, 2024.\n* Subjects born with 29 weeks of gestational age (wga) or less who were born between July 1st, 2023 and October 1st, 2023\n* Subjects born with Bronchopulmonary Dysplasia (BPD), 32 or less wga and\u002For a birth weight less than 1·5 kgs born between April 1st, 2023 and October 1st, 2023.\n\nExclusion Criteria:\n\n* No specific criteria has been reported","4 Years",{"count":293,"type":22},160000,"The Nirse-CL study is a collaborative effort between the Ministry of Health of Chile, Instituto Sistemas Complejos de Ingeniería (ISCI), and the Faculty of Medicine of the University of Chile. The primary aim is to determine the effectiveness of the monoclonal antibody nirsevimab in preventing RSV infection in infants based on the integrated analysis of several national databases before, during, and after the implementation of a universal immunization program. The impact of the program on RSV-related health outcomes will also be determined.",[28],[28,297],"Nirsevimab","2024-07-15",{"date":300,"type":40},"2024-07-22",{"date":302,"type":40},"2024-04-01",{"date":304,"type":22},"2024-10-01",{"name":306,"class":76},"Instituto Sistemas Complejos de Ingeniería"]