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Clinical trials for V419-008

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
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    The EU Clinical Trials Register currently displays   34872   clinical trials with a EudraCT protocol, of which   5674   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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    2 result(s) found for: V419-008. Displaying page 1 of 1.
    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: (No results available)
    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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    Query did not match any studies.
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