Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany

Vaccine. 2010 Jun 7;28(25):4192-203. doi: 10.1016/j.vaccine.2010.04.008. Epub 2010 Apr 22.

Abstract

13-valent pneumococcal conjugate vaccine (PCV13) was compared to PCV7 in infants administered 4 doses. For the 7 common serotypes, PCV13- and PCV7-elicited responses showed comparable percent responders achieving 0.35mug/mL IgG threshold (exception 6B, 77.5% versus 87.1%, respectively) and OPA titers of 1:8; IgGs were lower than PCV7 but functional responses were generally comparable. For the 6 additional serotypes, PCV13-elicited IgG and functional OPA responses were notably greater than PCV7. The toddler dose boosted immune responses. Vaccines were comparable with regard to safety. PCV13 should be as effective as PCV7 in preventing pneumococcal disease caused by the common serotypes and may provide protection against the additional serotypes.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial / blood
  • Double-Blind Method
  • Female
  • Germany
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Humans
  • Immunization Schedule
  • Immunoglobulin G / blood
  • Infant
  • Male
  • Pneumococcal Infections / prevention & control*
  • Pneumococcal Vaccines / adverse effects
  • Pneumococcal Vaccines / immunology*
  • Vaccines, Conjugate / immunology

Substances

  • 13-valent pneumococcal vaccine
  • Antibodies, Bacterial
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Immunoglobulin G
  • Pneumococcal Vaccines
  • Vaccines, Conjugate