To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
Infections, Rotavirus
About this trial
This is an interventional prevention trial for Infections, Rotavirus focused on measuring Prophylaxis against gastroenteritis caused by Rotavirus
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site