Evaluation of a diphtheria-tetanus-acellular pertussis- inactivated poliovirus-Hib vaccine given concurrently with meningococcal group C conjugate vaccine at 2, 3 and 4 months of age

Nicholas Kitchin ^1*, Joanna Southern ², Rhonwen Morris ³, Fabienne Hemme ¹, Stephane Thomas ⁴, Michael Watson ⁴, Keith Cartwright ³ and Elizabeth Miller ²

¹ Sanofi Pasteur MSD, United Kingdom
² Immunisation Department, Centre for Infections, Health Protection Agency, United Kingdom
³ Gloucester Vaccine Evaluation Unit, Health Protection Agency South West, United Kingdom
⁴ Sanofi Pasteur MSD, France

^* To whom correspondence should be addressed. E-mail: nkitchin{at}spmsd.com.

Accepted 11 April 2006

Abstract

Background: In view of the possible introduction of DTaP-IPV-Hib vaccine in the UK, a study of its immunogenicity when administered 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 subjects with anti-PRP 0.15 µg/mL was 93.2% (95% CI [86.6, 96.7]) in the Pediacel group, compared to 100.0% (95%CI [96.4, 100.0]) in the DTwP/Hib. The anti- PRP response was lower in subjects receiving either Pediacel or DTwP/Hib when these vaccines were given concomitantly with MCC-CRM compared with MCC-TT. For group C meningococcus, the proportion of subjects with serum bactericidal antibody (SBA) titre 1:8 in the Pediacel group was 99.0% compared with 100% in the DTwP/Hib group. The Men C SBA GMT was lower in those receiving Pediacel with MCC-TT compared to those receiving DTwP/Hib with MCC-TT, although all titres were well above the protective threshold. The Men C 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 administered at 2, 3 and 4 months of age. Co- administration of MCC vaccine can influence the Hib response, and the MCC response to a tetanus conjugate can be influenced by the nature of the co-administered DTP/Hib vaccine.

Keywords: acellular pertussis, combination vaccine, concomitant administration, immunogenicity

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