Evaluation of a diphtheria–tetanus–acellular pertussis–inactivated poliovirus–Haemophilus influenzae type b vaccine given concurrently with meningococcal group C conjugate vaccine at 2, 3 and 4 months of age
- 1Sanofi Pasteur MSD, Maidenhead, Berkshire, UK
- 2Immunisation Department, Centre for Infections, Health Protection Agency, London, UK
- 3Gloucester Vaccine Evaluation Unit, Health Protection Agency South West, Gloucester Royal Hospital, Gloucester, UK
- 4Sanofi Pasteur MSD, Lyon, France
- Correspondence to:
Dr N R E Kitchin
Sanofi Pasteur MSD, Mallards Reach, Bridge Avenue, Maidenhead, Berkshire SL6 1QP, UK;
- Accepted 11 April 2006
- Published Online First 2 May 2006
Background and objective: In view of the possible introduction of diphtheria–tetanus–acellular pertussis–inactivated poliovirus–Haemophilus influenzae type b (DTaP-IPV-Hib, eg Pediacel) vaccine in the UK, a study of the immunogenicity of Pediacel when given with one of two different meningococcal group C conjugate (MCC) vaccines at 2, 3 and 4 months of age was conducted.
Methods: Randomised controlled study in 241 infants.
Results: Post vaccination, the proportion of infants with anti-polyribosylribitol phosphate (PRP) levels ⩾0.15 μg/ml was 93.2% (95% confidence interval (CI) 86.6 to 96.7) in the Pediacel group compared with 100% (95% CI 96.4 to 100) in the diphtheria–tetanus–whole-cell pertussis–Haemophilus influenzae type b (DTwP-Hib) group. The anti-PRP response was lower in infants receiving either Pediacel or DTwP-Hib when these vaccines were given concomitantly with meningococcal group C conjugate with diphtheria-derived protein CRM197 as conjugate protein (MCC-CRM) compared with meningococcal group C conjugate with tetanus toxoid as conjugate protein (MCC-TT). For group C meningococcus, the proportion of infants with serum bactericidal antibody (SBA) titre ⩾1:8 in the Pediacel group was 99.0% compared with 100% in the DTwP-Hib group. The MCC SBA geometric mean titre (GMT) was lower in those receiving Pediacel with MCC-TT than in those receiving DTwP-Hib with MCC-TT, although all titres were well above the protective threshold. The MCC SBA GMT was similar in those receiving Pediacel and DTwP-Hib and MCC-CRM. Responses to all other vaccine components were equivalent in the two groups.
Conclusions: Pediacel is immunogenic when given at 2, 3 and 4 months of age. Coadministration of MCC vaccine can influence the Hib response, and the MCC response to a tetanus conjugate can be influenced by the nature of the coadministered DTP-Hib vaccine.
- DTaP-Hib, diphtheria–tetanus–acellular pertussis
- DTaP-IPV-Hib, diphtheria–tetanus–acellular pertussis–inactivated poliovirus–Haemophilus influenzae type b
- DTwP, diphtheria–tetanus–whole-cell pertussis
- DTwP-Hib, diphtheria–tetanus–whole-cell pertussis–Haemophilus influenzae type b
- GMC, geometric mean concentration
- GMT, geometric mean titre
- Hib, Haemophilus influenzae type b
- IPV, inactivated poliomyelitis vaccine
- ITT, intention-to-treat
- MCC, meningococcal group C conjugate
- MenC, meningococcal serogroup C
- MCC-CRM, meningococcal group C conjugate with diphtheria-derived protein CRM197 as conjugate protein
- MCC-TT, meningococcal group C conjugate with tetanus toxoid as conjugate protein
- OPV, oral poliomyelitis vaccine
- PRP, polyribosylribitol phosphate
- SBA, serum bactericidal antibody
Published Online First 2 May 2006
Funding: This study was funded by a grant provided by Sanofi Pasteur MSD, which covered the costs of the study nurses and was accepted in accordance with the code of practice of the Immunisation Department of the Health Protection Agency (http://www.hpa.org.uk/infections/about/dir/psp.pdf).
Competing interests: NREK, FH, ST and MWW are employees of Sanofi Pasteur MSD, which markets Pediacel and Act-HIB DTP.
Partial immunological data were presented at the 21st Annual Meeting of the European Society for Paediatric Infectious Diseases, Sicily, 9–11 April 2003 (abstract number 272).