Immunogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with the meningococcal serogroup B (4CMenB) vaccine in infants: A post-hoc analysis in a phase 3b, randomised, controlled trial

Vaccine. 2019 Aug 14;37(35):4858-4863. doi: 10.1016/j.vaccine.2019.07.021. Epub 2019 Jul 18.

Abstract

Background: No data are currently available on immunogenicity of higher-valent pneumococcal conjugate vaccines when co-administered with a 4-component meningococcal serogroup B vaccine (4CMenB).

Methods: Post-hoc analysis of pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) immunogenicity when co-administered with 4CMenB (2 + 1 schedule) and/or a CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM) in a trial assessing 4CMenB reduced schedules and co-administration with MenC-CRM (NCT01339923). Infants were randomized to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM (Group 2) at 3, 5, and 12 months (M) of age. Both groups received PHiD-CV (3 + 1 schedule) as part of the Brazilian national immunisation programme at 3 M, 5 M, 7 M, and 12 M of age. Antibody responses were assessed pre-vaccination, 1 M post-dose 2, pre-booster, and 1 M post-booster.

Results: Anti-pneumococcal antibody responses were in similar ranges in the two study groups.

Conclusions: 4CMenB co-administration did not seem to impact antibody responses to PHiD-CV in infants.

Keywords: Co-administration; Immunogenicity; Infants; Meningococcal conjugate vaccine; Pneumococcal conjugate vaccine.

Publication types

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

MeSH terms

  • Antibodies, Bacterial / blood
  • Brazil
  • Female
  • Haemophilus influenzae
  • Humans
  • Immunization Schedule
  • Immunogenicity, Vaccine*
  • Infant
  • Male
  • Meningitis, Meningococcal / prevention & control
  • Meningococcal Vaccines / administration & dosage*
  • Meningococcal Vaccines / immunology
  • Neisseria meningitidis, Serogroup B
  • Neisseria meningitidis, Serogroup C
  • Pneumococcal Infections / prevention & control*
  • Pneumococcal Vaccines / administration & dosage*
  • Pneumococcal Vaccines / immunology*
  • Serogroup
  • Streptococcus pneumoniae
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / immunology
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / immunology

Substances

  • 4CMenB vaccine
  • Antibodies, Bacterial
  • Meningococcal Vaccines
  • PHiD-CV vaccine
  • Pneumococcal Vaccines
  • Vaccines, Combined
  • Vaccines, Conjugate

Associated data

  • ClinicalTrials.gov/NCT01339923