One-year antibody persistence and safety of a 4-dose schedule of MenACWY-CRM in healthy infants from South Korea.

ABSTRACT:

Purpose

Results from a post-marketing study to generate evidence on 1-year antibody persistence and safety following vaccination of infants from South Korea with the quadrivalent meningococcal conjugate vaccine MenACWY-CRM.

Materials and methods

In this phase IV, open-label, multi-center study (NCT02446691), 128 infants received MenACWY-CRM at ages 2, 4, 6, and 12 months. One-year antibody persistence following the full vaccination course was evaluated (primary objective) for the four meningococcal serogroups (Men) by serum bactericidal activity assay using human or rabbit complement (hSBA/rSBA). Immune responses at 1-month post-vaccination and safety were also assessed.

Results

The percentage of children with hSBA titers ≥8 ranged between 94% (MenA) and 100% (MenY/W)

SUBMITTER: Lee HJ 

PROVIDER: S-EPMC6689500 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature