Objective: Assessment of immunogenicity and reactogenicity of DTPa-IPV/Hib (Infanrixquinta) and DTPa-IPV-HBV/Hib (Infanrixhexa) combined vaccines coadministered in healthy infants with 7-valent pneumococcal conjugate vaccine (Prevenar), according to the current French vaccine recommendations.
Method: Multicenter, open label, non-controlled study performed in France. Each subject received 1 dose of DTPa-IPV-HBV/Hib combined vaccine at 2, 4 and 16-18 months of age, coadministered with conjugated pneumococcal vaccine and 1 dose of DTPa-IPV/Hib vaccine at 3 months of age coadministered with conjugated pneumococcal vaccine.
Results: Among the 102 enrolled infants, 64 were analysed (10.09 weeks+/-1.22 of age; boys: 58%) in the According-To-Protocol (ATP) immunogenicity cohort. One month after the administration of the booster dose of DTPa-IPV-HBV/Hib vaccine, 93.8% of subjects had protective titres for anti-HBs antibody superior or equal to 10 mIU/ml (primary objective). Seroprotection rate against Haemophilus influenzae type b component (anti-PRP antibody >or=0.15 microg/ml) was 98.4% and the immune response for the 7-valent pneumococcal serotypes (antipneumococcal antibody >or=0,05 microg/ml) was between 98.4 and 100%. Local reactogenicity increased with the number of doses administered, but was comparable between combined vaccines and conjugated pneumococcal vaccine. The incidence of fever increased between the primary vaccination and the booster.
Conclusion: The immunogenicity and reactogenicity profile of DTPa-IPV-HBV/Hib and DTPa-IPV/Hib combined vaccines coadministered with conjugated pneumococcal vaccine according to the schedule recommended in the French vaccine calendar is acceptable and similar to previous reports.