Status:
COMPLETED
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Rotavirus Vaccines
Eligibility:
All Genders
5-10 years
Phase:
PHASE2
Brief Summary
This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
Eligibility Criteria
Inclusion
- Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.
- Birth weight of the subject should be \> 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 study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine 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. BCG is administered at birth according to the local EPI.
- Concurrently participating in another clinical study, at any time during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Key Trial Info
Start Date :
March 9 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2007
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00432380
Start Date
March 9 2007
End Date
September 4 2007
Last Update
January 2 2020
Active Locations (1)
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1
GSK Investigational Site
City of Muntinlupa, Philippines