Immunogenicity and safety of an indigenously developed DTPw hepatitis B combination vaccine in Indian infants.
Indian Pediatr
;
2008 Oct; 45(10): 819-23
Artigo
em Inglês
| IMSEAR
| ID: sea-15846
ABSTRACT
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 21 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 No patients were withdrawn from the study due to any adverse effects.INTERVENTIONS: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 OUTCOMEMEASURES:
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.
Texto completo:
DisponíveL
Índice:
IMSEAR (Sudeste Asiático)
Assunto principal:
Humanos
/
Vacina contra Difteria, Tétano e Coqueluche
/
Método Simples-Cego
/
Vacinas contra Hepatite B
/
Vacinas Combinadas
/
Índia
/
Lactente
Tipo de estudo:
Ensaio Clínico Controlado
País/Região como assunto:
Ásia
Idioma:
Inglês
Revista:
Indian Pediatr
Ano de publicação:
2008
Tipo de documento:
Artigo
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