Vaccine
Phase 2 trial to evaluate the safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine (IVT-PCV25) in infants
Par Bravo L, Bermal N, Alberto E et 11 autres.
Contenu en anglais
Résumé
Introduction
IVT-PCV25 is a 25-valent pneumococcal conjugate vaccine designed to broaden serotype coverage beyond current vaccines. We evaluated the safety and immunogenicity in infants of three dose-ranging formulations of IVT-PCV25 in comparison to licensed Prevnar-20.
Methods
In this double-blind phase 2 trial in the Philippines, 421 healthy infants were randomly assigned (1:1:1:1) to three IVT-PCV25-formulation arms or a Prevnar-20 arm. Three doses were administered 4-weeks apart from 6 weeks of age, alongside routine vaccinations. Adverse events (AEs), and IgG and functional antibody (opsonophagocytic; OPA) titres were assessed up to 28-days after Dose 3. Unlike IgG concentrations, OPA titres were only measured in a third of the population.