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Clinical trials for Vaccine Adverse Event Reporting System

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    8 result(s) found for: Vaccine Adverse Event Reporting System. Displaying page 1 of 1.
    EudraCT Number: 2019-001401-25 Sponsor Protocol Number: QHD00012 Start Date*: 2019-09-27
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Relative Effectiveness of a High-Dose Quadrivalent Influenza Vaccine versus a Standard-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older
    Medical condition: Prevention of influenza infection in adults from 65 years of age and older
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001170-29 Sponsor Protocol Number: V503-066 Start Date*: 2024-02-05
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 3, Open-label Clinical Study to Evaluate the Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age.
    Medical condition: Papillomavirus Infections
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10047438 Viral infectious disorders HLGT
    20.1 10021881 - Infections and infestations 10063001 Human papilloma virus infection LLT
    21.1 10042613 - Surgical and medical procedures 10071146 Human papilloma virus immunisation PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-002145-11 Sponsor Protocol Number: B1971015(6108A1-2005) Start Date*: 2013-05-23
    Sponsor Name:Pfizer Inc
    Full Title: A Phase 2, Randomized, Active-controlled, observer-blindED Trial, to Assess the Safety, Tolerability, and Immunogenicity of MCV4, TDAP Vaccine and bivalent RLP2086 Vaccine When Administered Concomi...
    Medical condition: Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10004049 Bacterial meningitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-003591-13 Sponsor Protocol Number: V503-076 Start Date*: 2024-05-06
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of 2-dose Regimens of 9vHPV and mRNA-1273 SARS-CoV-2 Vaccines Where the First Dose of Each Vaccine Are Given Conco...
    Medical condition: Papilloma viral infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10063001 Human papilloma virus infection LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-002137-38 Sponsor Protocol Number: B1971011(6108A1-2007) Start Date*: 2013-05-23
    Sponsor Name:Pfizer Inc
    Full Title: A Phase 2, Randomized, ACTIVE-CONTROLLED, observer-blinded Trial, to Assess the Safety, Tolerability, and Immunogenicity of Gardasil® (HPV) Vaccine and BIVALENT RLP2086 Vaccine When Administered Co...
    Medical condition: Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10004049 Bacterial meningitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003736-24 Sponsor Protocol Number: V503-069 Start Date*: 2021-03-03
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen with Extended Dosing Intervals in 9- to 14-Year Old ...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10047438 Viral infectious disorders HLGT
    20.1 10021881 - Infections and infestations 10063001 Human papilloma virus infection LLT
    21.1 10042613 - Surgical and medical procedures 10071146 Human papilloma virus immunisation PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-001676-21 Sponsor Protocol Number: V48P7E1 Start Date*: 2006-08-14
    Sponsor Name:Novartis Vaccines and Diagnostics GmbH & Co. KG
    Full Title: A phase IV, open-label, single-center study in adolescents and adults: Evaluation of immunogenicity and safety of the first booster immunization with Chiron’s TBE vaccine for adults in participants...
    Medical condition: TBE prophylaxis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10043847 Tick-borne viral encephalitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2019-004680-51 Sponsor Protocol Number: 212496 Start Date*: 2021-01-18
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and differe...
    Medical condition: Healthy volunteers (Active immunization for the prevention of disease caused by RSV in adults aged 60 years or above)
    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 Gender: Male, Female
    Trial protocol: FI (Ongoing) DE (Ongoing)
    Trial results: (No results available)
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    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.

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