Status:
COMPLETED
A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and t...
Detailed Description
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age in Hongkong and Taiwan or 11-17 weeks of age in Singapore, according to ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol.
- Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Child is unlikely to remain in the study area during study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
- First or second degree of consanguinity of parents.
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
10708 Patients enrolled
Trial Details
Trial ID
NCT00197210
Start Date
December 1 2003
End Date
July 1 2007
Last Update
November 4 2016
Active Locations (4)
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1
GSK Investigational Site
Singapore, Singapore, 119074
2
GSK Investigational Site
Singapore, Singapore, 228510
3
GSK Investigational Site
Singapore, Singapore, 229899
4
GSK Investigational Site
Singapore, Singapore, 308433