Extrait

PRIMARY SERIES: - To demonstrate that the concomitant administration of the hexavalent vaccine given at 2, 3 and 4 months of age with a meningococcal serogroup C conjugate (MenC) vaccine given at 2 and 4 months of age is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine. - To demonstrate that the concomitant administration of a MenC vaccine given at 2 and 4 months of age with the hexavalent vaccine given at 2, 3 and 4 months of age induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC. BOOSTER: To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate vaccine either co-administered at 12 months of age or given separately.

Critère d'inclusion

• Healthy infants 46 to 74 days of age (both inclusive)

Liens

• ictrp
• euctr