Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.

Abstract

Safety and reactogenicity data were reviewed following 10 years of experience with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in clinical development and from post-licensure settings. Analyses of pooled clinical trial data and post-marketing reports provided an overview of its safety profile and allowed assessment of rare adverse events that might not have been identified previously. The safety of PHiD-CV was also evaluated in children at higher risk for pneumococcal infection (preterm and HIV-infected or HIV-exposed infants), for different vaccination schedules and co-administered pediatric vaccines, and with a focus on special categories of adverse events (febrile convulsions, apnea, Kawasaki disease and sudden deaths). Following the distribution of over 235 million doses, PHiD-CV has been well tolerated when co-administered with other pediatric vaccines to children aged less than 5 years from diverse ethnic and geographic backgrounds. Detailed examination of various aspects has confirmed its favorable benefit: risk profile.

Keywords: PHiD-CV; Pneumococcal conjugate vaccine; adverse events; children; clinical trial; infants; pneumococcal disease; post-licensure; reactogenicity; safety.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials as Topic
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Drug-Related Side Effects and Adverse Reactions / pathology*
  • Haemophilus Infections / prevention & control
  • Humans
  • Pneumococcal Infections / prevention & control
  • Pneumococcal Vaccines / administration & dosage*
  • Pneumococcal Vaccines / adverse effects*
  • Product Surveillance, Postmarketing
  • Retrospective Studies

Substances

  • PHiD-CV vaccine
  • Pneumococcal Vaccines