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Clinical trials for RSV

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    123 result(s) found for: RSV. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2020-005996-11 Sponsor Protocol Number: MK-1654-007 Start Date*: 2021-08-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for S...
    Medical condition: Prevention of Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) DE (Trial now transitioned) FI (Trial now transitioned) Outside EU/EEA HU (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) GR (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004923-34 Sponsor Protocol Number: RSV-MVA-004 Start Date*: 2022-07-07
    Sponsor Name:Bavarian Nordic A/S
    Full Title: A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA-BN®-RSV Vaccine in Adults ≥60 Years of Age
    Medical condition: respiratory syncytial virus disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002742-37 Sponsor Protocol Number: 66735.041.18 Start Date*: 2018-09-12
    Sponsor Name:University Medical Center Utrecht
    Full Title: Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection – a randomized controlled trial
    Medical condition: respiratory syncytial virus infection
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000099-20 Sponsor Protocol Number: VAS00006 Start Date*: 2022-07-19
    Sponsor Name:Sanofi Pasteur
    Full Title: A Phase IIIb randomized open-label study of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial virus in infants (HARMONIE)
    Medical condition: respiratory syncytial virus (RSV) infection
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005980-30 Sponsor Protocol Number: 53718678RSV2008 Start Date*: 2021-11-26
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients with Respiratory Syncytial Virus (RSV) Infection...
    Medical condition: Respiratory Syncytial Virus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) PL (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-001862-56 Sponsor Protocol Number: 64041575RSV2004 Start Date*: 2018-01-09
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (...
    Medical condition: Respiratory syncytial virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) BE (Prematurely Ended) FI (Prematurely Ended) SK (Prematurely Ended) ES (Prematurely Ended) IE (Prematurely Ended) PT (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004582-27 Sponsor Protocol Number: RSV-MVA-013 Start Date*: 2018-07-23
    Sponsor Name:Bavarian Nordic A/S
    Full Title: A Phase 2a Randomized, Double-blinded, Placebo-controlled Trial to assess the Safety, Immunogenicity, and Efficacy of the recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infectio...
    Medical condition: Upper and lower respiratory tract infections caused by Respiratory Syncytical Virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10039247 RSV infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000357-26 Sponsor Protocol Number: 214709 Start Date*: 2021-09-14
    Sponsor Name:GlaxoSmithKline S.A.
    Full Title: A Phase III, observer-blind, randomized, multi-country study to evaluate the lot-to-lot consistency of GSK’s investigational RSV maternal vaccine and the immune response, safety and reactogenicity ...
    Medical condition: Healthy volunteers (prevention of RSV-associated lower respiratory tract illnesses (LRTIs))
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Temporarily Halted) FI (Completed)
    Trial results: View results
    EudraCT Number: 2021-003693-31 Sponsor Protocol Number: C3671013 Start Date*: 2021-09-30
    Sponsor Name:Pfizer Inc., 66 Hudson Boulevard East New York, NY 10001
    Full Title: A PHASE 3 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
    Medical condition: Prevention of RSV-associated lower respiratory tract illness in adults 60 years of age and older by active immunization
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000753-28 Sponsor Protocol Number: 212494 Start Date*: 2021-05-11
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase 3, randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose and annual revaccination of GSK’s RSVPreF3 OA investigational vaccine in ...
    Medical condition: Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10035732 Pneumonia respiratory syncytial viral PT
    21.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    21.1 10021881 - Infections and infestations 10069811 Respiratory syncytial virus bronchitis PT
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    21.1 10021881 - Infections and infestations 10035692 Pneumonia due to respiratory syncytial virus LLT
    21.1 10021881 - Infections and infestations 10067384 Respiratory syncytial virus pneumonitis LLT
    21.1 10021881 - Infections and infestations 10052200 Respiratory syncytial virus infection NOS LLT
    21.1 10021881 - Infections and infestations 10066741 Respiratory syncytial virus infection recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FI (Completed) DE (Completed) IT (Completed) SE (Prematurely Ended) HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001509-25 Sponsor Protocol Number: 53718678RSV2006 Start Date*: 2019-08-16
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled S...
    Medical condition: Acute Respiratory Tract Infection due to RSV
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10066740 Acute respiratory tract infection LLT
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Preterm newborn infants, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-000039-27 Sponsor Protocol Number: MI-CP110 Start Date*: 2004-08-09
    Sponsor Name:MedImmune, Inc.
    Full Title: A pivotal phase 3 study of MEDI-524 (Numax), an enhanced potency humanized respiratory syncytial virus (RSV) monoclonal antibody, for the prophylaxis of serious RSV disease in high-risk children.
    Medical condition: Serious respiratory syncytial virus (RSV) disease
    Disease: Version SOC Term Classification Code Term Level
    7.0 10061603
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) HU (Completed) CZ (Completed) DK (Completed) IS (Completed) AT (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-002302-39 Sponsor Protocol Number: RSV-M-301 Start Date*: 2016-09-06
    Sponsor Name:Novavax, Inc.
    Full Title: A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Alumi...
    Medical condition: Respiratory syncytial virus (RSV) is the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. In industrialized countries, nearly all children have...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: In utero, Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001355-40 Sponsor Protocol Number: 212171 Start Date*: 2021-02-23
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase III, randomized, double-blind, placebo-controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted RSV Maternal vaccine, administered IM to pregnant women 18 to ...
    Medical condition: Healthy Volunteers (prevention of lower respiratory tract illness)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed) FR (Completed) BE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-000825-33 Sponsor Protocol Number: MI-CP117 Start Date*: 2012-03-09
    Sponsor Name:MedImmune LLC
    Full Title: A Phase 3 Study of MEDI-524 (Motavizumab) for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States
    Medical condition: Serious Lower Respiratory Tract disease caused by RSV
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003642-93 Sponsor Protocol Number: 53718678RSV2002 Start Date*: 2018-12-05
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses o...
    Medical condition: Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10066740 Acute respiratory tract infection LLT
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) ES (Prematurely Ended) HU (Completed) SE (Completed) FR (Completed) DE (Prematurely Ended) PL (Completed) BG (Completed) Outside EU/EEA IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001667-24 Sponsor Protocol Number: PC_RSV_004 Start Date*: 2018-08-21
    Sponsor Name:Pulmocide Ltd
    Full Title: A double blind, placebo-controlled study to assess the anti-viral effect, safety and tolerability of inhaled PC786 for the treatment of acute respiratory syncytial virus (RSV) infection in adult he...
    Medical condition: Respiratory Syncytial Virus
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-002023-11 Sponsor Protocol Number: 53718678RSV3001 Start Date*: 2021-02-16
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (...
    Medical condition: Respiratory Syncytial Virus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BG (Completed) DE (Prematurely Ended) SE (Completed) CZ (Completed) HU (Completed) BE (Completed) PL (Completed) Outside EU/EEA EE (Completed) LV (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005458-97 Sponsor Protocol Number: VAC18193RSV3001 Start Date*: 2021-10-28
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years an...
    Medical condition: Prevention of Lower Respiratory Tract Disease Caused by The respiratory syncytial virus (RSV)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-005026-20 Sponsor Protocol Number: mRNA-1345-P301 Start Date*: 2022-08-04
    Sponsor Name:ModernaTX, Inc.
    Full Title: A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥ 60 Years...
    Medical condition: Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) BE (Completed) ES (Ongoing) PL (Completed)
    Trial results: (No results available)
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