Safety, tolerability, and immunogenicity of pentavalent meningococcal MenABCWY vaccine in healthy infants: A phase 2b randomized clinical trial.

ABSTRACT: Invasive meningococcal disease is an uncommon but serious disease predominantly affecting children. This phase 2b study evaluated MenABCWY in 6-month-old infants followed by MenB-fHbp and MenABCWY in 2-month-old infants, the latter being the target age and intervention. Participants were randomized to MenABCWY, 60 µg or 120 µg MenB-fHbp+MenACWY-TT, or 4CMenB+MenACWY-TT, administered as 2 primary and 1 booster dose. The primary safety objective was to describe the safety profile of MenABCWY in participants enrolled at 2 months. Primary immunogenicity objectives were the percentage of participants achieving seroprotective serum bactericidal antibody using human complement titers. Overall, 314 and 12 participants were randomized to sentinel cohort and open-label expanded-enrollment stages, re

SUBMITTER: Martinon-Torres F 

PROVIDER: S-EPMC11853628 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature