Immunogenicity and safety of a multi-human dose formulation of Biological E's 14-valent pneumococcal polysaccharide conjugate vaccine (PNEUBEVAX 14^®) administered to 6-8-week-old healthy infants: a phase 3, single-blind, randomized, active-controlled study.

ABSTRACT:

Background

Pneumococcal conjugate vaccines (PCVs) have considerably reduced the burden of invasive pneumococcal disease (PD) worldwide. Consequently, though, there has been an increase in non-vaccine serotype-induced PD particularly at both the extremes of age. Biological E has developed a 14-valent PCV (PNEUBEVAX 14®) that includes additional serotypes 22F and 33F. PNEUBEVAX 14® was shown to be safe, immunogenic, and non-inferior to Prevenar-13® (PCV-13) when administered to infants in a pivotal phase 3 trial. In this study, the multi-dose presentation of PNEUBEVAX 14® with 2-phenoxyethanol as a preservative was assessed for safety and immunogenicity in infants.

Methods

This was a phase 3, single-blind, randomized, active-controlled study in 6-8-week-old healthy infants, co

SUBMITTER: Thuluva S 

PROVIDER: S-EPMC12010144 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature