RESULTS OF A MULTICENTER CLINICAL STUDY OF A NEW COMBINATION VACCINE DTaP-HepB+Hib PRODUCTION OF THE CPA «MICROGEN» FOR IMMUNIZATION OF CHILDREN 6 MONTHS

Abstract

Aim. The aim of the study is evaluate of reactogenicity, safety and immunogenicity of the native combined vaccine DTaP-HepB+Hib. Materials and methods. Assessment of reactogenicity, safety and immunogenicity of the drug is investigated in a multicenter, comparative, randomized, simple-blind clinical trial of immunization of children 6 months (the comparator vaccine DTaP-HepB combined vaccine, Hiberix®). Results. The native combined vaccine DTaP-HepB+Hib is characterized by good tolerability, high safety profile and a pronounced immunogenicity. In terms of seroprotection, seroconversion and geometric mean titers of antibodies comparable to that used in Russia of vaccines DTP-HBV and Hiberix®. Conclusion. Vaccine DTaP-HepB+Hib can be recommended for registration in the territory of the Russian Federation for the prevention of pertussis, diphtheria, tetanus, hepatitis B and Hib-infection.

Keywords

• dtap-hepb+hib vaccine
• reactogenicity
• safety
• immunogenicity