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Clinical trials for V419-008

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    The EU Clinical Trials Register currently displays   43440   clinical trials with a EudraCT protocol, of which   7185   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).

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    3 result(s) found for: V419-008. Displaying page 1 of 1.
    EudraCT Number: 2020-000126-26 Sponsor Protocol Number: V419-013 Start Date*: 2020-07-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    Full Title: A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-...
    Medical condition: Long-term protection against HBV infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10019743 Hepatitis B virus (HBV) LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2016-000274-37 Sponsor Protocol Number: PRI03C Start Date*: 2016-03-21
    Sponsor Name:MCM Vaccine B.V.
    Full Title: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4- to 5 year old Children Previously Vaccinated with a 2-dose or 3-dose Infants series and Toddler dose with VAXELIS...
    Medical condition: Vaxelis is indicated for primary and booster vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B (HB), poliomyelitis and invasive diseases caused by Haemophilus ...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10054187 Polio immunization LLT
    19.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    19.0 100000004865 10069593 Pertussis immunization LLT
    19.0 100000004865 10054181 Hepatitis B immunization LLT
    19.0 100000004865 10054180 Diphtheria immunization LLT
    19.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2010-021491-28 Sponsor Protocol Number: V419-008 Start Date*: 2012-01-26
    Sponsor Name:Sanofi Pasteur MSD S.N.C.
    Full Title: A phase III randomized, double-blind, active-comparator controlled clinical trial to study the safety, tolerability, and immunogenicity of V419 in healthy infants when given at 2, 4, and 11 to 12 m...
    Medical condition: PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004848 10019743 Hepatitis B virus (HBV) LLT
    16.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    16.0 100000004865 10069593 Pertussis immunization LLT
    16.0 100000004865 10054181 Hepatitis B immunization LLT
    16.0 100000004865 10053386 Poliomyelitis vaccine LLT
    16.0 100000004865 10054180 Diphtheria immunization LLT
    16.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) IT (Completed)
    Trial results: View results
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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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