Extrait

To demonstrate the immunogenicity of the MenACWY-TT conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135 and Y one month post-dose 3 of MenACWY-TT at 7 months of age in healthy infants. Criteria for immunogenicity: For each serogroup, one month after dose 3 of MenACWY-TT vaccination, the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.

Critère d'inclusion

• Active immunisation of healthy infants to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y