At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,274 enrolled
Drug / intervention
Lyophilized formulation of HRV vaccine +1 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 Study to Assess the Immunogenicity, Reactogenicity and Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated HRV Vaccine, Given as a Two-dose Primary Vaccination, in Healthy Infants Previously Uninfected With HRV
In Brief
A Phase 3 clinical trial evaluating Lyophilized formulation of HRV vaccine and Liquid formulation of HRV vaccine for Infections, Rotavirus. Completed, enrolled 1,274 participants across 3 sites.
Detailed Summary
This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
CountriesPanama
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2006
Enrollment StartSep 2006
Primary CompletionApr 2007
TodayJul 2026
First PostedAug 15, 2006
Enrollment StartSep 1, 2006
Primary CompletionApr 12, 2007
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 19.9 years ago
Interventions
Lyophilized formulation of HRV vaccinebiological
Lyophilized formulation of HRV vaccine
Liquid formulation of HRV vaccinebiological
Liquid formulation of HRV vaccine