Status:
COMPLETED
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief Summary
To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess r...
Eligibility Criteria
Inclusion
- Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of \> 2000 grams.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00345956
Start Date
September 1 2006
End Date
March 1 2007
Last Update
October 28 2016
Active Locations (2)
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1
GSK Investigational Site
Hanoi, Vietnam, 084
2
GSK Investigational Site
Nhatrang, Vietnam, 084