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

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.

• Authors: A Bose, A P Dubey, D Gandhi, A Pandit, M B Raghu, P Raghupathy, M I S Rao, V P Verghese, S K Datta, H L Bock
• Journal: Indian pediatrics (Indian Pediatr) Vol. 44 Issue 6 Pg. 421-4 (Jun 2007) ISSN: 0019-6061 [Print] India
• PMID: 17620694 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Diphtheria-Tetanus-acellular Pertussis Vaccines

Topics

• Child
• Child, Preschool
• Diphtheria-Tetanus-acellular Pertussis Vaccines (administration & dosage, adverse effects)
• Female
• Guideline Adherence
• Humans
• Immunization (adverse effects)
• India
• Male
• Patient Compliance
• Prospective Studies
• Whooping Cough (prevention & control)