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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 No patients were withdrawn from the study due to any adverse effects.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 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.
Assuntos
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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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