At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 100 enrolled
Drug / intervention
Rotarix +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Reactogenicity and Immunogenicity of Three Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine
In Brief
A Phase 2 clinical trial evaluating Rotarix, Placebo, and 2 other interventions for Infections, Rotavirus. Completed, enrolled 100 participants across 6 sites.
Detailed Summary
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
CountriesSouth Africa
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
First PostedDec 2005
Primary CompletionFeb 2008
Study CompletionFeb 2008
TodayJul 2026
First PostedDec 9, 2005
Enrollment StartMar 16, 2005
Primary CompletionFeb 7, 2008
Study CompletionFeb 13, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.6 years ago
Interventions
Rotarixbiological
Oral vaccination
Placebobiological
Oral administration
Tritanrix-HB+Hibbiological
Concomitant routine vaccination, IM administration
Polio Sabinbiological
Oral administration, concomitant routine vaccination