At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 405 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.
A Study to Assess the Efficacy, Immunogenicity and Safety of Two Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in Healthy Infants.
In Brief
A Phase 2 clinical trial evaluating Rotarix for Infections, Rotavirus. Completed, enrolled 405 participants.
Detailed Summary
To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2000
Primary CompletionJul 2001
First PostedJan 2007
TodayJul 2026
First PostedJan 23, 2007
Enrollment StartAug 1, 2000
Primary CompletionJul 1, 2001
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.4 years ago
Interventions
Rotarixbiological