Immunogenicity and reactogenicity of a three-dose primary vaccination course with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-haemophilus influenzae type b vaccine coadministered with a meningococcal C conjugate vaccine

Pediatr Infect Dis J. 2004 Dec;23(12):1109-15.


Aim: To evaluate the immunogenicity and safety of 3 doses of the combined diphtheria-tetanus toxoids-acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine (Infanrix hexa) when coadministered with a CRM197-conjugated meningococcal C vaccine (Meningitec) at different injection sites during the same visit or during separate visits.

Methods: Healthy infants were randomized in an open randomized multicenter study to receive either the DTPa-HBV-IPV/Hib and meningococcal C conjugate vaccines during the same vaccination visit at 2, 4 and 6 months of age (coadministration group) or the DTPa-HBV-IPV/Hib vaccine at 2, 4 and 6 months of age and the meningococcal C conjugate vaccine at 3, 5 and 7 months of age (separate administration group).

Results: The immunogenicity analysis included 452 infants, 228 in the coadministration group and 224 in the separate administration group. One month after primary vaccination, 99.1% of subjects in both groups achieved anti-polyribosylribitol phosphate antibody concentrations >/=0.15 microg/mL. The vaccine response against pertussis antigens was at least 99.1% in both groups. For all other DTPa-HBV-IPV/Hib vaccine antigens, at least 97.8% of all subjects of both groups were seroprotected. In addition, 99.5% of all subjects had meningococcal C bactericidal antibody titers >/=1/8 and 99.1% >/=1/128. Coadministration of both vaccines did not result in an increased local or general reactogenicity compared with separate administration.

Conclusion: Coadministration of the combined DTPa-HBV-IPV/Hib vaccine and the meningococcal C conjugate vaccine during the same vaccination visit was immunogenic and safe.

Publication types

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

MeSH terms

  • Antibodies, Bacterial / blood
  • Antibodies, Viral / blood
  • Bacterial Capsules
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Female
  • Haemophilus Vaccines / administration & dosage
  • Haemophilus Vaccines / adverse effects
  • Haemophilus Vaccines / immunology*
  • Hepatitis B Vaccines
  • Humans
  • Infant
  • Male
  • Meningococcal Vaccines / administration & dosage
  • Meningococcal Vaccines / adverse effects
  • Meningococcal Vaccines / immunology*
  • Poliovirus Vaccine, Inactivated
  • Polysaccharides, Bacterial / administration & dosage
  • Polysaccharides, Bacterial / adverse effects
  • Polysaccharides, Bacterial / immunology*
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / adverse effects
  • Vaccines, Combined / immunology*


  • Antibodies, Bacterial
  • Antibodies, Viral
  • DTPa-HBV-IPV combined vaccine
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Haemophilus Vaccines
  • Haemophilus influenzae type b polysaccharide vaccine
  • Hepatitis B Vaccines
  • Meningococcal Vaccines
  • Poliovirus Vaccine, Inactivated
  • Polysaccharides, Bacterial
  • Vaccines, Combined
  • serogroup C meningococcal conjugate vaccine