At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 enrolled
Drug / intervention
Rotavirus Vaccine, Live, Oral, Pentavalentbiological
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.
Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India
In Brief
A Phase 3 clinical trial evaluating Rotavirus Vaccine, Live, Oral, Pentavalent for Gastroenteritis and Rotavirus. Completed, enrolled 110 participants.
Detailed Summary
To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroenteritis, Rotavirus
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2007
Enrollment StartMay 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedJul 4, 2007
Enrollment StartMay 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 19.0 years ago
Interventions
Rotavirus Vaccine, Live, Oral, Pentavalentbiological
Pentavalent vaccine 9G1, G2, G3, G4 \& P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.