CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 178 enrolled
Drug / intervention
Rotavirus Vaccine, Live, Oral, Pentavalent +1 morebiological
Likely dose
3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2AI-extracted
Key inclusion· 1
  • ✓Age 6 weeks through exactly 12 weeks at first vaccination
Key exclusion· 4
  • ✕History of congenital abdominal disorders, intussusception, or abdominal surgery
  • ✕History of known prior rotavirus disease
  • ✕Ongoing chronic diarrhea or failure to thrive
  • ✕Clinical evidence of active gastrointestinal illness

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

Search/NCT00166517
NCT00166517Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Merck Sharp & Dohme LLC·interventional·Posted Sep 14, 2005·Updated Apr 1, 2015

In Brief

A Phase 3 clinical trial evaluating Rotavirus Vaccine, Live, Oral, Pentavalent and Comparator: Placebo for Rotavirus. Completed, enrolled 178 participants.

Detailed Summary

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartAug 1, 2005
Primary CompletionJul 1, 2006
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.8 years ago

Interventions

Rotavirus Vaccine, Live, Oral, Pentavalentbiological

3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2

Comparator: Placebobiological

3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2