Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial

BMC Infect Dis. 2013 Feb 21;13:95. doi: 10.1186/1471-2334-13-95.

Abstract

Background: Pneumococcal infections are major causes of child mortality and morbidity worldwide and antibiotic resistance of Streptococcus pneumoniae is a major concern, especially in Asian countries. The present study was designed to evaluate the reactogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the licensed diphtheria, tetanus, acellular pertussis, hepatitis B virus, inactivated poliovirus and H. influenzae type b vaccine (DTPa-HBV-IPV/Hib) in a 3-dose primary vaccination course in Vietnamese infants.

Methods: This phase III, open, randomised study was conducted in one centre in Ho Chi Minh City between February and July 2011. Healthy infants (N=300) were randomised (2:1) to receive either PHiD-CV co-administered with DTPa-HBV-IPV/Hib (PHiD-CV group) or DTPa-HBV-IPV/Hib alone (Control group) at 2, 3, and 4 months of age.

Results: Within 31 days post-vaccination, 8.2% of overall doses in the PHiD-CV group and 3.0% of overall doses in the Control group were followed by at least one solicited and/or unsolicited, local and/or general adverse event of grade 3 intensity. Pain at injection site was the most common grade 3 solicited symptom, which was reported following 6.5% and 1.0% of overall doses in the PHiD-CV and Control groups, respectively. Within 4 days post-vaccination, the most common solicited local and general symptoms reported with any intensity were pain (48.9% and 31.0% of doses in the PHiD-CV and Control groups) and irritability (58.0% and 40.4% of doses in the PHiD-CV and Control groups). Within 31 days post-vaccination, the incidence of unsolicited symptoms was comparable in both groups (following 12.3% and 14.8% of doses in the PHiD-CV and Control groups, respectively). Throughout the study, 13 serious adverse events (SAEs) were reported in 9 infants in the PHiD-CV group and 11 SAEs in 6 infants in the Control group. None of them were fatal or considered causally related to vaccination.

Conclusions: PHiD-CV had a clinically acceptable safety profile when co-administered with DTPa-HBV-IPV/Hib in Vietnamese infants. The reactogenicity of PHiD-CV was comparable to that observed in other South-East Asian populations.

Trial registration: ClinicalTrials.gov NCT01153841.

Publication types

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

MeSH terms

  • Bacterial Proteins / immunology
  • Carrier Proteins / immunology
  • Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
  • Diphtheria-Tetanus-Pertussis Vaccine / adverse effects
  • Drug-Related Side Effects and Adverse Reactions / etiology
  • Female
  • Hepatitis B Vaccines / administration & dosage
  • Hepatitis B Vaccines / adverse effects
  • Humans
  • Immunoglobulin D / immunology
  • Infant
  • Infant, Newborn
  • Lipoproteins / immunology
  • Male
  • Pneumococcal Vaccines / administration & dosage*
  • Pneumococcal Vaccines / adverse effects*
  • Poliovirus Vaccine, Inactivated / administration & dosage
  • Poliovirus Vaccine, Inactivated / adverse effects
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / adverse effects
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / adverse effects
  • Vietnam

Substances

  • 10-valent pneumococcal vaccine
  • Bacterial Proteins
  • Carrier Proteins
  • DTPa-HBV-IPV combined vaccine
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Hepatitis B Vaccines
  • Immunoglobulin D
  • Lipoproteins
  • Pneumococcal Vaccines
  • Poliovirus Vaccine, Inactivated
  • Vaccines, Combined
  • Vaccines, Conjugate
  • glpQ protein, Haemophilus influenzae

Associated data

  • ClinicalTrials.gov/NCT01153841