Safety and immunogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated polio vaccine-Haemophilus influenzae type b vaccine administered at 2-4-6-13 or 3-5-12 months of age

摘要: Methods. In an open randomized study we compared the safety and immunogenicity of two schedules for priming booster vaccinations infants. A pentavalent combination vaccine, including a lyophilized Haemophilus influenzae type b-tetanus toxoid conjugate vaccine reconstituted with liquid diphtheria, tetanus, acellular pertussis (pertussis filamentous hemagglutinin) inactivated polio (DTaP-IPV/Act-HIB®; Pasteur Merieux Connaught, Lyon, France) was administered to 236 Swedish infants either at 2, 4 6 months or 3 5 months, dose 7 after last primary dose. Adverse events were monitored by diaries days each vaccination questions ensuing visits. Antibodies against different components analyzed series vaccinations, before injections. Results. There no serious adverse reactions, rates febrile local reactions low in both groups. The three schedule induced higher geometric mean concentrations all antigens than did schedule, but there differences between groups proportions protective antibody titers Hib certain defined levels antibodies. Prebooster results showed similar pattern, exception that group primed injections detectable antibodies polio-virus types 1 3. After above concentrations, indicating effective from vaccinations. Conclusion. combined DTaP-IPV/ Act-HIB® equally safe immunogenic when according time studied.