[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"influenza-b\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:influenza-b":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,76,100,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100626036","clinical-validation-of-an-at-home-flu-ab-and-covid-19-rapid-test-100626036",false,"NCT07430410","Clinical Validation of an At-Home Flu A\u002FB and COVID-19 Rapid Test","Human Factors and Clinical Validation of the CorDx Tyfast Flu A\u002FB & COVID-19 At Home Multiplex Rapid Test Using Anterior Nares Nasal Samples for Over-The-Counter (OTC) Use","Inclusion Criteria:\n\n1. Written informed consent obtained prior to study enrollment.\n2. Male or female aged 2 years or older.\n3. Subjects were tested with a Food Drug and Administration (FDA) cleared molecular assay no more than 2 days prior to the study visit.\n4. Subject, aged 2 years or older, is currently exhibiting one or more symptoms associated with COVID-19 or influenza such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea and must present within 5 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.\n\nExclusion Criteria:\n\n1. Subject who is 18 years of age (or the state's legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.\n2. Subject has had seasonal influenza vaccine within the past 5 days.\n3. Subject is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.\n4. Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).\n5. Subjects currently undergoing treatment and\u002For within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.\n6. Subjects 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.\n7. Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.","ALL","2 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"NA","The study's primary objective is to evaluate the performance of the CorDx Tyfast Flu A\u002FB \\& COVID-19 At-Home Test for detecting SARS-CoV-2, Influenza A, and B in nasal samples collected by lay users, compared to 510(k)-cleared RT-PCR tests. Secondary objectives are to assess usability and instruction comprehension and reproducibility with untrained operators at Clinical Laboratory Improvement Amendments (CLIA)-waived sites.",[26,27,28],"SARS-CoV-2 Infection","Influenza A","Influenza B","NOT_YET_RECRUITING","2026-02-23",{"date":32,"type":33},"2026-02-25","ACTUAL",{"date":35,"type":20},"2026-02-12",{"date":37,"type":20},"2027-02-12",{"name":39,"class":40},"CorDx, Inc.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100617152","phase-3-adaptive-platform-trial-of-treatments-for-respiratory-infections-in-community-settings-treatresp-100617152","NCT07314905","Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp)","Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings","TreatResp","Inclusion Criteria:\n\n* 18 years or older\n* A positive test (PCR or RAT) for one of the pathogens included in the trial's domains (influenza A\u002FB, or other future specified respiratory pathogens),\n* Enrolled within 5 days of symptoms onset. However, this window may vary depending on the domain or specific interventions within each domain (for example 72 hours for Baloxavir).\n* At least two symptoms commonly associated with respiratory infections, including:\n\n  * rhinitis\n  * cough\n  * wheezing\n  * sore throat\n  * nasal congestion\n  * shortness of breath\n  * fatigue\n  * rapid breathing\n  * excessive mucus production\n  * loss of smell or taste\n  * hemoptysis\n  * trouble sleeping or insomnia due to breathing difficulties\n  * fever (defined for purposes of this study as \\>37.5°C\u002F 41).\n\nExclusion Criteria:\n\n* Admitted to hospital or in an ED for more than 24 hours\n* Previously randomized to TreatResp within the past 12 months\n* Currently participating in a clinical trial of a therapeutic agent for acute respiratory pathogen infection that is not\u002Fsuspected not compatible with the study therapeutics\n* Already taking a study therapeutic or contraindication to a study therapeutic\n* Inability for participant or caregiver to provide informed consent.\n\nAdditional eligibility criteria will be applied based on the intervention assigned. For instance, if a participant is randomized to an antiviral treatment, they must not have contraindications specific to that antiviral. This ensures that each treatment is evaluated in a population for whom it is most appropriate and safe.\n\nBaloxavir exclusion:\n\n* Has a known or suspected pregnancy\n* Is breastfeeding\n* Is of childbearing potential and is not willing to use a highly effective contraceptive\n* Has advanced chronic kidney disease (CKD stage 3: eGFR ≥30 to \\\u003C60 mL\u002Fmin, and severe renal impairment (eGFR \\\u003C30 ml\u002Fmin, CKD stage 4-5)\n* Has severe hepatic impairment, or requires a live viral vaccine within the next seven days\n* Has a significant impaired immunity (e.g., due to long-term oral steroids, chemotherapy, or an immune disorder)\n* Requires immediate antiviral treatment or hospitalization as per the clinician's judgment\n* Is allergic to trial medications\n* Is scheduled for elective surgery or procedures requiring general anesthesia within the next two weeks\n* Is co-infected with viruses of interest\n* Received a live viral vaccine within the last 14 days","18 Years",{"count":51,"type":20},264,[53],"PHASE3","TreatResp is a double-blind, individually randomized, multi-centre adaptive platform trial. TreatResp aims to establish an adaptive platform trial aimed at evaluating the clinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics for respiratory pathogens in non-hospitalized patients. Participants will be randomized to receive usual care (i.e., supportive care and symptom relief) or a study therapeutic, which will be determined by the TreatResp Therapeutics Committee. The primary outcomes being evaluated is time to recovery.",[27,28,56,57],"SAR-CoV-2","Acute Respiratory Infections (ARIs)",[59,60,27,28,61,62,63,64,65],"COVID-19","SARS-CoV-2","Influenza","Respiratory pathogens","Respiratory infections","Adaptative Platform Trials (APT)","acute respiratory infections (ARIs)","2025-12-31",{"date":68,"type":33},"2026-01-02",{"date":68,"type":20},{"date":71,"type":20},"2027-04-24",{"name":73,"class":74},"Unity Health Toronto","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":75},"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":83,"type":20},2000,[23],"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.",[87,27,28,88,89,90],"COVID -19","Respiratory Synctial Virus","RSV","Rhinovirus","2025-10-14",{"date":93,"type":33},"2025-10-16",{"date":95,"type":20},"2025-11-01",{"date":97,"type":20},"2026-09-01",{"name":99,"class":40},"Aptitude Medical Systems",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100577642","phase-3-phase-iii-clinical-trial-of-quadrivalent-influenza-virus-split-vaccine-100577642","NCT06800950","Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine","A Randomized, Blinded, Positive-controlled Phase III Clinical Trial of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above","Inclusion Criteria:\n\n* Age Requirement: volunteers aged 3 years and above at the time of enrollment.\n* Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: Volutters, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.\n* Requirements for contraception: agree to take contraception actions in 6 months.\n* Temperature Requirement: Axillary body temperature is less than 37.3°C.\n* Previous Vaccination Requirements: (a) Received at least 1 dose of influenza vaccine within 1 year before screening in children aged 3-8 years; (b) Never received any influenza vaccine 1 year before screening in children aged over 3 years.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria will be not eligible for enrollment.\n\n* Subjects with a history of severe allergy to egg or egg protein, such as those who have had symptoms such as angioedema, dyspnea, chest distress, or repeated vomiting due to eating eggs, and even those who have used epinephrine or other emergency medical treatment, especially those who have symptoms immediately or within a short period (minutes to hours).\n* Subjects with influenza illness (clinically, serologically, or microbiologically confirmed) within 6 months before screening and enrollment.\n* Have received an influenza vaccine within 1 year before enrollment or scheduled to receive another influenza vaccine during the study period.\n* Allergic to any component contained in the investigational vaccine, or previous history of severe allergic to any vaccine or drug, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local allergic necrosis reaction, dyspnea, angioedema, systemic rash and\u002For urticaria, etc.\n* History of taking administration of a non-SARS-CoV-2 inactivated vaccine or subunit vaccine within 7 days before enrollment, or any live attenuated vaccine or SARS-CoV-2 vaccine within 14 days before enrollment, or subjects have scheduled to receive another vaccine within 1 month after receipt of the investigational vaccine\n* Subjects with convulsion, epilepsy, encephalopathy (such as moderate to severe hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumor, cerebral infarction, stroke, intracranial infection, etc.), psychiatric history or family history\n* Have been diagnosed with a serious medical condition or congenital malformation that may interfere with the conduct or completion of the study (including but not limited to suffering from respiratory diseases such as asthma or during episodes of chronic bronchitis, Down syndrome, thalassemia, heart disease, severe cardiac arrhythmias, kidney disease, diabetes (diabetics with poor glycemic control or severe complications), autoimmune diseases, genetic allergies, Guillain-Barre syndrome, Crohn disease, malignancies, severe infectious\u002Fallergic skin diseases, etc.)\n* Adults aged 18 years or older with medically uncontrolled abnormal blood pressure (systolic blood pressure ≥140mmHg and\u002For diastolic blood pressure ≥90mmHg or systolic blood pressure ≤ 90mmHg and\u002For diastolic blood pressure ≤ 60 mmHg)\n* Subjects with acute illness or in the acute phase of a chronic illness within 3 days before vaccination\n* Subjects with fever (axillary temperature ≥37.3 ° C) within 3 days before vaccination or use of antipyretic, analgesic, or antiallergic medications\n* Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders\n* Have received a blood transfusion or use of blood products within 3 months before enrollment, or planned to do so within 1 month after full immunization\n* History of surgical removal of the spleen or other vital organs for any reason\n* Use of any investigational or unregistered product (drug, vaccine, biological product, or device) other than a study vaccine within 3 months before enrollment or planned for use during the study\n* Have treatment with immunosuppressive agents within 6 months before enrollment, such as long-term systemic glucocorticoid therapy (e.g., prednisone or a similar drug for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) was allowed. Topical use should not exceed the recommended dose on the label or have any signs of systemic exposure\n* Have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study, such as active tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, etc\n* Being lactating, pregnant (including a positive urine pregnancy test), or planning to become pregnant within 6 months of vaccination\n* Subjects plan to move out of the local area before the end of the study or leave the local area for an extended period during the scheduled study visit\n* Subjects with abnormal vital signs with clinical significance\n* Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.",true,"3 Years",{"count":110,"type":20},4400,[53],"This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization, and primary safety endpoints are the occurrence of safety events after vaccination including the incidence of adverse events\u002Fadverse reactions within 30 minutes\u002F7 days\u002F30 days after immunization, as well as the incidence of serious adverse events\u002Fadverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary endpoints are to evaluate the same index above in different administration programs in children aged 3-8 years.",[114,115,116,28,117],"Influenza, Human","Influenza, Human Prevention","Influenza a","Influenza Viral Infections","2025-01-24",{"date":120,"type":33},"2025-01-30",{"date":122,"type":20},"2025-02-08",{"date":124,"type":20},"2025-10-15",{"name":126,"class":74},"Institute of Medical Biology, Chinese Academy of Medical Sciences",3,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":127},"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":136,"type":20},1000,[23],"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.",[116,28,89,140],"COVID 19","RECRUITING","2024-11-01",{"date":144,"type":33},"2024-11-04",{"date":146,"type":33},"2024-09-30",{"date":148,"type":20},"2025-05",{"name":150,"class":40},"DiaSorin Molecular LLC"]