Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Respiratory Syncytial Virus (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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    116 result(s) found for: Respiratory Syncytial Virus (RSV). Displaying page 4 of 6.
    « Previous 1  2  3  4  5  6  Next»
    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: 2024-000422-17 Sponsor Protocol Number: C3671016 Start Date*: 2024-08-26
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 1, OPEN-LABEL, AGE DESCENDING, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (RSVpreF) IN CHILDREN ...
    Medical condition: Prevention of RSV-associated lower respiratory tract illness in children 2-18 years of age by active immunization
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-002213-18 Sponsor Protocol Number: EDP938-103 Start Date*: 2020-11-05
    Sponsor Name:Enanta Pharmaceuticals, Inc.
    Full Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Adult Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection o...
    Medical condition: Respiratory syncytial virus (RSV)
    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: FR (Completed) DE (Prematurely Ended) BE (Completed) PL (Prematurely Ended) GR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003252-24 Sponsor Protocol Number: 53718678RSV2004 Start Date*: 2018-01-16
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ- 53718678 at Two Dose Le...
    Medical condition: Respiratory Syncytial Virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10038717 Respiratory syncytial viral infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) SE (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-002028-26 Sponsor Protocol Number: AK0529-1003 Start Date*: Information not available in EudraCT
    Sponsor Name:Ark Biosciences Pty Ltd.
    Full Title: A Randomised, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered AK0529 to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Single and Multiple Dosing ...
    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: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000431-27 Sponsor Protocol Number: 204894 Start Date*: 2018-12-18
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase 1/2, randomized, observer-blind, controlled, multi-center study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ respiratory syncytial virus (RSV) investigational v...
    Medical condition: Active immunization of infants for the prevention of any lower respiratory tract infections (LRTI; bronchiolitis and [broncho] pneumonia) associated with respiratory syncytial virus (RSV).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) BE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001677-33 Sponsor Protocol Number: D5290C00003 Start Date*: 2016-09-22
    Sponsor Name:MedImmune, LLC
    Full Title: A Phase 2b Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, ...
    Medical condition: The prevention of medically attending RSV LRTI.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Preterm newborn infants, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) CZ (Completed) HU (Completed) BG (Completed) PL (Completed) FR (Completed) BE (Completed) SE (Completed) EE (Completed) LV (Completed) FI (Completed) LT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-014758-14 Sponsor Protocol Number: 201177 Start Date*: 2010-05-13
    Sponsor Name:West Middlesex University Hospital
    Full Title: Does nebulised hypertonic (3%) saline reduce the duration of hospital admission in infants with bronchiolitis?
    Medical condition: Viral bronchiolitis (in infants aged under 1yr old)
    Disease: Version SOC Term Classification Code Term Level
    12-1 10038718 (Respiratory syncytial virus) bronchiolitis LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-000114-11 Sponsor Protocol Number: D5290C00004 Start Date*: Information not available in EudraCT
    Sponsor Name:MedImmune, LLC
    Full Title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, i...
    Medical condition: The prevention of medically attended RSV LRTI.
    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: BE (Completed) LV (Completed) GB (GB - no longer in EU/EEA) SE (Completed) FR (Completed) DE (Completed) CZ (Completed) LT (Completed) EE (Completed) FI (Completed) PL (Completed) AT (Completed) ES (Ongoing) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001714-96 Sponsor Protocol Number: R2222-RSV-1332 Start Date*: 2015-11-03
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in ...
    Medical condition: Medically attended respiratory syncytial virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10038717 Respiratory syncytial viral infections HLT
    Population Age: Preterm newborn infants, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) GB (Completed) HU (Completed) FI (Completed) BG (Completed) ES (Completed) CZ (Completed) NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2025-000021-13 Sponsor Protocol Number: D5290C00009 Start Date*: 2025-04-24
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III Single-Arm Open-Label Study to Evaluate the Safety PK ADA and Anti RSV nAb Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants With CHD, CLD, Immunoco...
    Medical condition: Medically attended Respiratory Syncytial Viral (RSV) Lower respiratory tract infection(LRTI)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    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: 2020-001355-40 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: 2016-000221-39 Sponsor Protocol Number: M15-539 Start Date*: 2017-12-14
    Sponsor Name:AbbVie Inc
    Full Title: A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infectio...
    Medical condition: Severe Respiratory Syncytial Virus (RSV) Infection
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-000994-96 Sponsor Protocol Number: 214725 Start Date*: 2021-07-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase III, double-blind, randomized, placebo-controlled study to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of unadjuvanted RSV Maternal vaccine, in hi...
    Medical condition: High risk pregnant women (prevention of RSV-associated lower respiratory tract illnesses (LRTIs) in infants)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: FI (Completed) ES (Temporarily Halted) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001551-39 Sponsor Protocol Number: 53718678RSV2005 Start Date*: 2019-11-14
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-5371...
    Medical condition: Respiratory Syncytial Virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10038717 Respiratory syncytial viral infections HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) ES (Completed) SE (Completed) BE (Completed) BG (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003859-36 Sponsor Protocol Number: VAC18194RSV2002 Start Date*: 2019-03-27
    Sponsor Name:Janssen Vaccines and Prevention B.V.
    Full Title: A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
    Medical condition: Prophylactic respiratory syncytial virus (RSV)
    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, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) FI (Completed) ES (Completed) Outside EU/EEA PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-005041-41 Sponsor Protocol Number: 53718678RSV2001 Start Date*: 2015-04-24
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the antiviral activity, safety, and pharmacokinetics of repeated doses of orally administered JNJ-53718678 against Respi...
    Medical condition: Respiratory Syncytial Virus
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10038717 Respiratory syncytial viral infections HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-003221-30 Sponsor Protocol Number: D5290C00008 Start Date*: 2021-10-22
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ ...
    Medical condition: RSV disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-004036-30 Sponsor Protocol Number: ALS-8176-502 Start Date*: 2013-11-29
    Sponsor Name:Alios BioPharma
    Full Title: A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered ALS-008176 Against Respirator...
    Medical condition: Respiratory Syncytial Virus (RSV) infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10038717 Respiratory syncytial viral infections HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    « Previous 1  2  3  4  5  6  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 13 10:07:07 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA