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
in En
| 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.
Full text:
1
Index:
IMSEAR
Main subject:
Female
/
Humans
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Male
/
Child
/
Child, Preschool
/
Whooping Cough
/
Prospective Studies
/
Immunization
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Patient Compliance
/
Guideline Adherence
Type of study:
Observational_studies
Country/Region as subject:
Asia
Language:
En
Journal:
Indian Pediatr
Year:
2007
Type:
Article