Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines

Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S77-88. doi: 10.1097/INF.0b013e318199f609.


Background: Immunogenicity of the candidate 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was assessed when coadministered with other routine pediatric vaccines including different Neisseria meningitidis serogroup C conjugate vaccines.

Methods: One thousand five hundred forty-eight healthy infants received, according to a balanced (1:1:1:1) randomization, either PHiD-CV coadministered with (1) DTPa-HBV-IPV/Hib (Infanrix hexa) and MenC-CRM (Meningitec), (2) DTPa-HBV-IPV/Hib and MenC-TT (NeisVac-C), or (3) DTPa-HBV-IPV (Infanrix penta/Pediarix) and Hib-MenC-TT (Menitorix); or 7vCRM (Prevenar/Prevnar) coadministered with DTPa-HBV-IPV and Hib-MenC-TT at 2-4-6 months of age with a booster dose at 11-18 months. Serotype-specific pneumococcal responses were measured by 22F-inhibition ELISA and opsonophagocytic (OPA) assay.

Results: In all 3 coadministration groups, PHiD-CV was immunogenic for each of the 10 pneumococcal vaccine serotypes as assessed by post-primary and post-booster antibody ELISA and OPA responses. When coadministered with DTPa-HBV-IPV, Hib, and MenC antigens, PHiD-CV responses after the third primary dose were within the same range as 7vCRM responses in terms of the percentage of subjects achieving an ELISA antibody concentration >or=0.2 microg/mL for all common vaccine serotypes (over 92% of subjects) except for serotype 6B (at least 87% of subjects). ELISA and OPA immune responses were also evident after the second primary doses of PHiD-CV or 7vCRM vaccine, although antibody levels were below that achieved after 3 primary doses, particularly for serotypes 6B and 23F. The kinetics of the immune responses from after the second dose to after the booster dose were similar for most of the serotypes in both PHiD-CV and 7vCRM groups.

Conclusions: PHiD-CV was immunogenic when coadministered with other routine pediatric vaccines including MenC conjugate vaccines.

Trial registration: NCT00334334 NCT00463437.

Publication types

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

MeSH terms

  • Antibodies, Bacterial / blood*
  • Bacterial Proteins / immunology*
  • Carrier Proteins / immunology*
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Hepatitis B Vaccines
  • Humans
  • Immunization, Secondary
  • Immunoglobulin D / immunology*
  • Infant
  • Lipoproteins / immunology*
  • Male
  • Meningococcal Infections / immunology
  • Meningococcal Infections / microbiology
  • Meningococcal Infections / prevention & control
  • Meningococcal Vaccines* / administration & dosage
  • Meningococcal Vaccines* / immunology
  • Neisseria meningitidis, Serogroup C / immunology*
  • Opsonin Proteins / metabolism
  • Phagocytosis
  • Pneumococcal Infections / immunology
  • Pneumococcal Infections / microbiology
  • Pneumococcal Infections / prevention & control
  • Pneumococcal Vaccines* / administration & dosage
  • Pneumococcal Vaccines* / adverse effects
  • Pneumococcal Vaccines* / immunology
  • Poliovirus Vaccine, Inactivated
  • Serotyping
  • Streptococcus pneumoniae / classification
  • Streptococcus pneumoniae / immunology
  • Treatment Outcome
  • Vaccination
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / immunology
  • Vaccines, Conjugate* / administration & dosage
  • Vaccines, Conjugate* / immunology


  • Antibodies, Bacterial
  • Bacterial Proteins
  • Carrier Proteins
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Hepatitis B Vaccines
  • Immunoglobulin D
  • Lipoproteins
  • Meningococcal Vaccines
  • Opsonin Proteins
  • Pneumococcal Vaccines
  • Poliovirus Vaccine, Inactivated
  • Vaccines, Combined
  • Vaccines, Conjugate
  • glpQ protein, Haemophilus influenzae

Associated data