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Clinical trials for Palivizumab

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   44347   clinical trials with a EudraCT protocol, of which   7375   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 ).  
     
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    22 result(s) found for: Palivizumab. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2019-000201-69 Sponsor Protocol Number: D5290C00005 Start Date*: 2019-08-13
    Sponsor Name:MedImmune, LLC
    Full Title: A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-...
    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) DE (Completed) BG (Completed) CZ (Completed) EE (Completed) HU (Completed) LT (Completed) PL (Completed) FI (Completed) AT (Completed) FR (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001044-26 Sponsor Protocol Number: MB05-P-01-20 Start Date*: 2020-05-12
    Sponsor Name:mAbxience Research S.L.
    Full Title: A Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated with Respiratory Syncytial Virus (RSV)
    Medical condition: Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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: 2020-004137-21 Sponsor Protocol Number: 78591.041.21 Start Date*: 2021-10-28
    Sponsor Name:University Medical Center Utrecht
    Full Title: Effect of intranasal administration of palivizumab on experimental respiratory syncytial viral infection – a human challenge study
    Medical condition: respiratory syncytial virus infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004105-10 Sponsor Protocol Number: RSV- NTR1023 Start Date*: 2008-07-07
    Sponsor Name:Wilhelmina Children's Hospital
    Full Title: Effect of palivizumab on respiratory syncytial virus-associated burden of disease – a randomized controlled trial
    Medical condition: Long term respiratory complaints as a possible consequence of RSV bronchiolitis
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004491-31 Sponsor Protocol Number: M12-420 Start Date*: 2015-02-03
    Sponsor Name:Abbott Japan Co., Ltd
    Full Title: Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less with Immunocompromised Medical Conditions
    Medical condition: Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-002980-25 Sponsor Protocol Number: PRESERV Start Date*: 2020-06-12
    Sponsor Name:OSP.DEGLI INFERMI DI BIELLA
    Full Title: Randomized, multicenter, open-label study on PREvention of respiratory SEquelae of RSV bronchiolitis in preterm babies (PRESERV)
    Medical condition: Respiratory sincizial virus (RSV) bronchiolitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    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: 2014-004527-42 Sponsor Protocol Number: W10-664 Start Date*: 2015-02-03
    Sponsor Name:Abbott Laboratories LLC
    Full Title: A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis® in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation.
    Medical condition: Severe Respiratory Syncytial Virus Infection (RSV)
    Disease: Version SOC Term Classification Code Term Level
    17.1 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: 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: 2005-001671-35 Sponsor Protocol Number: MI-CP124 Start Date*: 2005-08-16
    Sponsor Name:MedImmune, Inc.
    Full Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Childr...
    Medical condition: Serious respiratory syncytial virus (RSV) disease in children with hemodynamically significant congential heart disease (CHD).
    Disease: Version SOC Term Classification Code Term Level
    7.0 10061603 PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) SE (Completed) CZ (Prematurely Ended) BE (Completed) DE (Completed) DK (Completed) AT (Prematurely Ended) ES (Completed) Outside EU/EEA
    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: 2007-002070-61 Sponsor Protocol Number: MI-CP124-S2 Start Date*: 2007-09-04
    Sponsor Name:MedImmune, LLC
    Full Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Childr...
    Medical condition: Serious respiratory syncytial virus (RSV) disease in children with hemodynamically significant congential heart disease (CHD).
    Disease: Version SOC Term Classification Code Term Level
    9.0 10061603 PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) SE (Completed) BE (Completed) HU (Completed) DE (Completed) FR (Completed) PL (Completed) CZ (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003274-32 Sponsor Protocol Number: 2015/233 Start Date*: 2016-07-13
    Sponsor Name:Dra Maria Luz Couce [...]
    1. Dra Maria Luz Couce
    2. Dr. José Luis Fernández Trisac
    Full Title: Effect of caffeine citrate in acute bronchiolitis symptoms of apnea in neonates and infants during the first three months of life
    Medical condition: Children under 3 years with acute RSV bronchiolitis which present breaks apnea
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002688-14 Sponsor Protocol Number: 201510 Start Date*: 2015-02-11
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase II, randomised, observer-blind, controlled, multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of different formulations of GlaxoSmit...
    Medical condition: Healthy, non-pregnant women (intended indication: prevention of severe RSV disease in infants by transfer of maternal antibodies following active single dose immunisation of pregnant women)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    17.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    17.1 10021881 - Infections and infestations 10035692 Pneumonia due to respiratory syncytial virus LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (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: 2016-001135-12 Sponsor Protocol Number: 204812 Start Date*: 2016-10-27
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase II, randomised, observer-blind, controlled, multi-country study to rank different formulations of GSK Biologicals’ investigational RSV vaccine (GSK3003891A), based on immunogenicity, reacto...
    Medical condition: Respiratory Syncytial Virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) EE (Completed) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-000337-36 Sponsor Protocol Number: FSJD-GLUCOBR-2010 Start Date*: 2011-08-30
    Sponsor Name:FUNDACIÓ SANT JOAN DE DÉU
    Full Title: IMPACT OF THE ADMINISTRATION OF SYSTEMIC GLUCOCORTICOIDS ON INFLAMMATORY RESPONSE AND CLINICAL EVOLUTION OF PATIENTS DIAGNOSED WITH MODERATE-SEVERE BRONCHIOLITIS
    Medical condition: Viral bronchiolitis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2023-000864-67 Sponsor Protocol Number: COAV101A1IC01 Start Date*: 2024-02-02
    Sponsor Name:NOVARTIS BIOCIÊNCIAS S.A
    Full Title: A Phase IV Open-label, single-arm, single-dose, multicenter study to evaluate the saFEty, toLerability and effIcacy of gene replacement therapy with intravenous OAV101(AVXS101) in pediatric patien...
    Medical condition: Spinal Muscular Atrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000117-76 Sponsor Protocol Number: 204838 Start Date*: 2016-09-27
    Sponsor Name:GlaxoSmithKline S.A.
    Full Title: A Phase 1/2, randomized, observer-blind, controlled, multi-center, dose-escalation study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ respiratory syncytial virus (RSV) ...
    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 [subtypes A...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    21.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    21.1 10021881 - Infections and infestations 10035692 Pneumonia due to respiratory syncytial virus LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) PL (Completed) IT (Completed)
    Trial results: View results
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