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

The objective was to evaluate the safety and reactogenicity of a reduced-antigen-content combined Diphtheria-Tetanus-Acellular Pertussis (dTpa) vaccine in Indian pre-school children. GlaxoSmithKline Biologicals combination dTpa vaccine was administered as a single booster dose to 347 children aged 4-6 years in seven centers across India. All children were subsequently followed up for two weeks for safety and reactogenicity assessment. 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 hoursin all cases. There were no other severe local reactions including large injection site reactions. The reduced-antigen-content combined dTpa vaccine is safe and well tolerated in Indian pre-school children. (authors)