[Safety and immunogenicity of the diphtheria, tetanus, accellular pertussis plus hemophilus influenza type b combined vaccine (DTaP-Hib) to Chinese infants].

Abstract

Objective: To evaluate the safety and immunogenicity of combined diphtheria, tetanus, accellular pertussis Plus hemophilus influenza type b vaccine (DTaP-Hib)to Chinese infants.

Methods: Safety study (study A), and immunogenicity and safety study (study B) were conducted in infants aged 3, 4 and 5 months. The immune response and safety of the DTaP-Hib vaccine were compared after administered DTaP and Hib separately based on specified criteria.

Results: A total of 690 healthy infants received primary vaccination with combined DTaP-Hib or administered DTaP and Hib(DTaP+Hib) separately. Immunogenicity was assessed before and one month after vaccination in a subjet. The tolerance of DTaP-Hib vaccine was at least as same as administered DTaP+Hib separately. The differences of local and general adverse events following immunigation (AEFI) between groups had no difference statisticaly significantly. At least 97.5% of DTaP-Hib recipients had seroprotection against diphtheria, tetanus and Hib, and response to acellular pertussis antigens one month after primary vaccination. The immune response of the DTaP-Hib vaccine was comparable to administered DTaP+Hib based on specified criteria separately.

Conclusion: The combined DTaP-Hib vaccine gets expected safety and immunogenicity.