CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 793 enrolled
Drug / intervention
rotavirus vaccine, live, oral, pentavalent +1 morebiological
Likely dose
~6.91–8.81 × 10^7 IU per dose, oral, three doses administered 4–10 weeks apartAI-extracted
Key inclusion· 1
  • ✓Healthy infants
Key exclusion· 5
  • ✕History of abdominal disorders from birth defect, intussusception, or abdominal surgery
  • ✕Known or suspected immune system problems
  • ✕Fever at time of immunization
  • ✕Prior rotavirus vaccine administration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00092456
NCT00092456Phase 3Completed
CompareCT.gov

Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants

Merck Sharp & Dohme LLC·interventional·Posted Sep 27, 2004·Updated Oct 5, 2015

In Brief

A Phase 3 clinical trial evaluating rotavirus vaccine, live, oral, pentavalent and Placebo for Rotavirus Infections. Completed, enrolled 793 participants.

Detailed Summary

This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus Infections
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2004
Enrollment StartMay 1, 2003
Primary CompletionAug 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 21.8 years ago

Interventions

rotavirus vaccine, live, oral, pentavalentbiological

Three oral doses (\~8.81 X 10\^7 IU/Dose for Lot 1; \~8.01 X 10\^7 IU/Dose for Lot 2; and \~6.91 X 10\^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination

Placebobiological

Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination