An open-label, phase IV randomised controlled trial of two schedules of a four-component meningococcal B vaccine in UK preterm infants.

ABSTRACT:

Objective

To compare immunological responses of preterm infants to a four-component meningococcal B vaccine (4CMenB; Bexsero) following a 2+1 vs a 3+1 schedule, and to describe reactogenicity of routine vaccines.

Design

An open-label, phase IV randomised study conducted across six UK sites.

Setting

Neonatal units, postnatal wards, community recruitment following discharge.

Participants

129 preterm infants born at a gestation of <35 weeks (64 in group 1 (2+1), 65 in group 2 (3+1)) were included in the analysis. Analysis was completed for postprimary samples from 125 participants (59 in group 1, 66 in group 2) and for postbooster samples from 118 participants (59 in both groups).

Interventions

Infants randomised to 4CMenB according to a 2+1 or a 3+1 schedu

SUBMITTER: Calvert A 

PROVIDER: S-EPMC11503106 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature