Extrait

The co-primary objectives of the primary & booster phases will be assessed in a sequential fashion: One month after the primary vaccination course, to demonstrate the non-inferiority of the -meningococcal serogroup C and -Hib immune response induced by GSK Biologicals’ Hib-MenC conjugate vaccine given concomitantly with Infanrix™-IPV compared to a licensed meningococcal serogroup C vaccine given concomitantly with Pediacel™ when given as a 3-dose primary vaccination in infants at 2, 3 and 4 months of age. 42 days after the booster vaccination, to evaluate the immunogenicity in terms of the percentage of subjects with -SBA-MenC titres >= 1:128 and -anti-PRP antibody concentration >= 1 µg/ml induced by a booster dose of GSK Biologicals’ Hib-MenC vaccine given concomitantly with Priorix™ in toddlers aged 12 to 15 months who have been primed with either 3 doses of Infanrix™-IPV and Hib-MenC or Pediacel™ and a licensed meningococcal serogroup C vaccine.

Critère d'inclusion

• Three-dose primary vaccination course with a haemophilus influenzae type B and meningococcal serogroup C conjugate vaccine of infants starting between 6 to 12 weeks of age with one month interval between doses and a single booster dose at 12 to 15 months of age

Liens

• ictrp
• euctr