Safety and reactogenicity of a low dose diphtheria tetanus acellular pertussis vaccine (Boostrix) in pre-school Indian children.

Autor:	Bose A; Department of Community Health, Christian Medical College, Vellore, India., Dubey AP, Gandhi D, Pandit A, Raghu MB, Raghupathy P, Rao MI, Verghese VP, Datta SK, Bock HL
Jazyk:	angličtina
Zdroj:	Indian pediatrics [Indian Pediatr] 2007 Jun; Vol. 44 (6), pp. 421-4.
Abstrakt:	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.
Databáze:	MEDLINE
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