Status:
COMPLETED
Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth in Developing Countries?
Lead Sponsor:
Bandim Health Project
Collaborating Sponsors:
International Cooperation with Developing Countries
March of Dimes
Conditions:
Tuberculosis
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE4
Brief Summary
The World Health Organization (WHO) currently recommends BCG vaccination at birth in developing countries. Pre-term infants should be vaccinated when they reach the chronological age of 40 weeks. Due ...
Detailed Description
Criteria for verification: 1,600 low birth weight (LBW) infants recruited at the national hospital and local health centres and enrolled in a randomised trial of BCG vaccination at birth versus later ...
Eligibility Criteria
Inclusion
- Must weigh less than 2500 g at birth
- Must be able to nurse
- Must be healthy enough to be discharged from the hospital
Exclusion
- Overt illness
- Malformation
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
2320 Patients enrolled
Trial Details
Trial ID
NCT00146302
Start Date
November 1 2002
End Date
March 1 2008
Last Update
March 19 2012
Active Locations (1)
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1
Bandim Health Project, Apartado 861
Bissau, Guinea-Bissau