At a glance
ClinicalIndex Comparison Record- ✓Healthy male or female infant aged 5–10 weeks (inclusive) at first vaccination
- ✓Healthy as established by medical history and clinical examination
- ✓In South Africa: birth weight >2000 grams or gestation >36 weeks (if weight unknown)
- ✓Written informed consent from parent/guardian of legal age
- ✕Prior investigational or non-registered product within 30 days before first vaccine dose
- ✕Concurrent participation in another clinical study involving investigational or non-investigational products
- ✕Any vaccine not foreseen by protocol within 14 days before and after each study vaccine dose
- ✕Chronic immunosuppressant use (>14 days) since birth
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
In Brief
A Phase 3 clinical trial evaluating Rotarix™ and Placebo for Infections, Rotavirus. Completed, enrolled 2,089 participants across 13 sites in 2 countries.
Detailed Summary
The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the 20-point Vesikari scoring system \[Ruuska, 1990\]) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 5. The primary objective will be reached if the lower limit of the 95% confidence interval (CI) on vaccine efficacy is \>0%. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
Two or Three doses, oral administration
One or three doses, oral administration.