At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,020 enrolled
Drug / intervention
RotaTeq™ experimental formulation +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 Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
In Brief
A Phase 3 clinical trial evaluating RotaTeq™ experimental formulation and RotaTeq™ existing formulation for Rotavirus Gastroenteritis. Completed, enrolled 1,020 participants.
Detailed Summary
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus Gastroenteritis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartApr 2013
Primary CompletionMar 2014
TodayJul 2026
First PostedMay 16, 2012
Enrollment StartApr 29, 2013
Primary CompletionMar 25, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.1 years ago
Interventions
RotaTeq™ experimental formulationbiological
RotaTeq™ existing formulationbiological