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

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 No patients were withdrawn from the study due to any adverse effects.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