Immunogenicity and safety of an indigenously developed DTPw hepatitis B combination vaccine in Indian infants.

摘要: Objective: To evaluate the safety and immunogenicity of an indigenous hepatitis B, diphtheria, tetanus B. pertussis tetravalent vaccine (Shantetra TM ) in comparison with Tritanrix HB healthy Indian infants. Design: Multicentric, randomized, single blind intention-to-treat study 12-18 weeks follow up period. Setting: 5 out patient departments at tertiary care referral centers across India. Participants: 151 infants were randomized a 2:1 ratio to recruit 101 Shantetra 50 groups respectively. A total 136 subjects completed study. No patients withdrawn from due any adverse effects. Interventions: Recruited receive three doses either two DTPw-Hepatitis B combination vaccines as per EPI schedule. Main Outcome Measures: Monitoring humoral immune response (seroconversion rates) induced by each antigenic component six after last dose both groups. Results: Seroprotective was observed 98.9% for components group compared 95.5% group. Anti-pertussis antibody seen 89% 91.1 % groups, The commonly events were, pain injection site, mild fever transient crying. Conclusion: indigenously developed demonstrated present