At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 2,464 enrolled
Drug / intervention
Rotarixbiological
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.
Study to Assess Efficacy, Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at Different Viral Concentrations in Healthy Infants Previously Uninfected With Human Rotavirus and Approximately 3 Months of Age.
In Brief
A Phase 2 clinical trial evaluating Rotarix for Hepatitis B. Completed, enrolled 2,464 participants.
Detailed Summary
To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2001
Primary CompletionApr 2003
First PostedJan 2007
TodayJul 2026
First PostedJan 31, 2007
Enrollment StartJan 1, 2001
Primary CompletionApr 1, 2003
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.4 years ago
Interventions
Rotarixbiological