Extrait

• To assess immunological non-inferiority of rMenB+OMV NZ and MenACWY when concomitantly administered compared to either alone in healthy infants at 3, 5, 7 and 13 months of age, as measured by the ratio of hSBA Geometric Mean Titers (GMTs) against each of the serogroup B indicator strains (for rMenB+OMV NZ) and serogroups A, C, W-135 and Y (for MenACWY) at one month after the fourth vaccination. Non-inferiority will be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ, and rMenB+OMV NZ + MenACWY versus MenACWY) is > 0.5 for all serogroup B indicator strains and all serogroups A, C, W-135 and Y.

Critère d'inclusion

• Healthy volunteers (Infections, Meningoccal)