Status:
COMPLETED
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
5-10 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.
Eligibility Criteria
Inclusion
- Healthy infants born after a normal gestation period (\>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother.
- Written informed consent was obtained from the parent/guardian of the subject before study entry.
Exclusion
- History of allergic disease/polio disease,
- Confirmed or suspected immunosuppressive or immunodeficient condition,
- Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator,
- Received treatment prohibited by the protocol.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT00383903
Start Date
September 1 2003
End Date
September 1 2004
Last Update
September 15 2016
Active Locations (6)
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1
GSK Investigational Site
Brits, South Africa, 0250
2
GSK Investigational Site
Ga-Rankuwa, South Africa, 0208
3
GSK Investigational Site
Pretoria, South Africa, 2
4
GSK Investigational Site
Pretoria North, South Africa, 2