Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio virus, Haemophilus influenzae type b and control hepatitis A vaccines

Vaccine. 2008 Aug 18;26(35):4563-70. doi: 10.1016/j.vaccine.2008.05.080. Epub 2008 Jun 17.

Abstract

This randomized (1:1), double-blind, multicenter study, included 4,968 healthy infants to receive either the 11-valent pneumococcal protein D (PD)-conjugate study vaccine or the hepatitis A vaccine (HAV) (control) at 3, 4, 5, and 12-15 months of age. The three-dose primary course of both vaccines was co-administered with combined hexavalent DTPa-HBV-IPV/Hib vaccine. The pneumococcal PD-conjugate study vaccine did not impact the immune response of co-administered hexavalent vaccine and the control HAV vaccine induced seropositivity (antibodies >or=15 mIU/mL) in all infants. The incidence of solicited symptoms was higher with the 11-valent pneumococcal PD-conjugate study vaccine, yet similar to that induced by concomitant DTPa-HBV-IPV/Hib vaccine. Overall, the reactogenicity and safety profile of the 11-valent pneumococcal PD-conjugate vaccine when co-administered with the hexavalent DTPa-HBV-IPV/Hib vaccine, as well as the immunogenicity of the co-administered hexavalent vaccine, were consistent with previous reports for the licensed DTPa-HBV-IPV/Hib and pneumococcal conjugate vaccines.

Publication types

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

MeSH terms

  • Antibodies, Bacterial / blood
  • Bacterial Proteins / immunology*
  • Carrier Proteins / immunology*
  • Double-Blind Method
  • Female
  • Haemophilus Vaccines / adverse effects*
  • Hepatitis A Vaccines / immunology*
  • Humans
  • Immunization, Secondary
  • Immunoglobulin D / immunology*
  • Infant
  • Lipoproteins / immunology*
  • Male
  • Pneumococcal Vaccines / adverse effects*
  • Vaccines, Conjugate / immunology*

Substances

  • Antibodies, Bacterial
  • Bacterial Proteins
  • Carrier Proteins
  • Haemophilus Vaccines
  • Hepatitis A Vaccines
  • Immunoglobulin D
  • Lipoproteins
  • Pneumococcal Vaccines
  • Vaccines, Conjugate
  • glpQ protein, Haemophilus influenzae