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Safety and reactogenicity of a low dose diphtheria tetanus acellular pertussis vaccine (Boostrix) in pre-school Indian children.
Indian Pediatr ; 2007 Jun; 44(6): 421-4
Article Dans Anglais | IMSEAR | ID: sea-13171
ABSTRACT

OBJECTIVE:

To evaluate the safety and reactogenicity of a reduced-antigen-content combined Diphtheria Tetanus Acellular Pertussis (dTpa) vaccine in Indian preschool children.

METHODS:

GlaxoSmithKline Biologicals combination dTpa vaccine was administered as a single booster dose to 347 children aged 46 years in seven centers across India. All children were subsequently followed up for two weeks for safety and reactogenicity assessment.

RESULTS:

A total of 345 subjects completed the study and two subjects were lost to follow-up. One serious adverse event (head injury) unrelated to vaccination was reported. Otherwise, all subjects were in good health throughout the study period. Three subjects (0.9%) reported transient general symptoms (such as irritability and drowsiness), which prevented normal activity. Pain at injection site, swelling and redness was reported in 31.1%, 18.2% and 8.9% subjects respectively. Five subjects (1.4%) reported severe pain preventing normal movement. This resolved within 48 hours in all cases. There were no other severe local reactions including large injection site reactions.

CONCLUSION:

The reduced antigen content combined dTpa vaccine is safe and well tolerated in Indian pre-school children.
Sujets)
Texte intégral: Disponible Indice: IMSEAR (Asie du Sud-Est) Sujet Principal: Femelle / Humains / Mâle / Enfant / Enfant d'âge préscolaire / Coqueluche / Études prospectives / Immunisation / Observance par le patient / Adhésion aux directives Type d'étude: Étude observationnelle Pays comme sujet: Asie langue: Anglais Texte intégral: Indian Pediatr Année: 2007 Type: Article

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Texte intégral: Disponible Indice: IMSEAR (Asie du Sud-Est) Sujet Principal: Femelle / Humains / Mâle / Enfant / Enfant d'âge préscolaire / Coqueluche / Études prospectives / Immunisation / Observance par le patient / Adhésion aux directives Type d'étude: Étude observationnelle Pays comme sujet: Asie langue: Anglais Texte intégral: Indian Pediatr Année: 2007 Type: Article