A phase 3, randomized, double-blind trial comparing the safety and immunogenicity of the 7-valent and 13-valent pneumococcal conjugate vaccines, given with routine pediatric vaccinations, in healthy infants in Brazil ☆

摘要: Abstract Background The inclusion of 7-valent pneumococcal conjugate vaccine (PCV7) into national immunization programs in many countries has significantly decreased the incidence disease caused by Streptococcus pneumoniae . However, a substantial portion remained and, some areas, there been an increase produced serotypes not included PCV7. A 13-valent (PCV13) was studied healthy Brazilian infants phase 3, double-blind, randomized study. Methods Infants were to receive either PCV7 or PCV13 at 2, 4, 6, (doses 1–3), and 12 (toddler dose) months age, along with routine pediatric vaccinations (diphtheria, tetanus, whole-cell pertussis, Haemophilus influenzae type b vaccine). Pneumococcal anticapsular polysaccharide-binding immunoglobulin G (IgG) responses antibody pertussis antigens measured 1 month after both dose 3 infant series toddler dose. Safety tolerability also assessed. Results proportion subjects achieving serotype-specific IgG concentration ≥0.35 μg/mL comparable (≥94.2%) (≥93.0%) groups for 7 common vaccines. percentage responders 6 additional ranged from 87.1 100% PCV13. varied across studied, but different recipients. Overall, safety profile that Conclusions tolerability, elicited immune serotypes, did interfere concomitantly administered vaccine. robust immunogenicity exhibited suggests it could provide significant protection against these serotypes.