Immunogenicity and safety of GlaxoSmithKline Biologicals' Havrix administered on a 0, 6-month schedule concomitantly with Merck and Company, Inc. M-M-R II and Merck and Company, Inc. VARIVAX to health...

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-001509-15

Immunogenicity and safety of GlaxoSmithKline Biologicals' Havrix administered on a 0, 6-month schedule concomitantly with Merck and Company, Inc. M-M-R II and Merck and Company, Inc. VARIVAX to healthy children 15 months of age

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Extrait

To demonstrate non-inferiority of the anti-HAV immune response (with respect to both seropositivity rates and GMCs) 31 days following the second dose of Havrix when the first dose of Havrix is co-administered with M-M-RII and VARIVAX (HAV+MMR+V Group) compared to Havrix given alone (HAV Group), To demonstrate the non-inferiority of the anti-measles, anti-mumps, anti-rubella and anti-varicella immune responses (with respect to seroconversion rates for anti-measles, anti-mumps and anti-varicella and seroresponse rate for anti-rubella) 42 days following the co-administration of M-M-RII and VARIVAX with the first dose of Havrix (HAV+MMR+V Group) compared to when M-M-RII and VARIVAX are given alone (MMR+V→HAV Group).


Critère d'inclusion

  • Active immunization against hepatitis A of healthy children 15 months of age at the time of the first study vaccination

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