Immunogenicity and safety of an indigenously developed DTPw hepatitis B combination vaccine in Indian infants.
| Autor: | Shah R; Department of Pediatrics, Shardaben General Hospital and Smt NHL Municipal Medical College, Ahmedabad, India. rajucshah@gmail.com, Raghu MB, Shivananda A, Mangayarkarasi S, Rao I, Rao R, Bhusari P, Joseph CA, Reddy R |
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| Jazyk: | angličtina |
| Zdroj: | Indian pediatrics [Indian Pediatr] 2008 Oct; Vol. 45 (10), pp. 819-23. |
| Abstrakt: | 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 No patients were withdrawn from the study due to any adverse effects.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. |
| Databáze: | MEDLINE |
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