CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 735 enrolled
Drug / intervention
Rotavirus Vaccine, Live, Oral, Pentavalent +2 morebiological
Likely dose
Pentavalent rotavirus vaccine, live, oral: three doses given on Day 1, then 56-84 days post Dose 1, and 56-84 days post Dose 2; Oral Poliovirus Vaccine: three doses given concomitantly or staggered 14-28 days after RotaTeq dosesAI-extracted
Key inclusion· 1
  • ✓Infants in good health
Key exclusion· 11
  • ✕Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine
  • ✕Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study
  • ✕Any condition resulting in depressed immunity
  • ✕Any allergy to any vaccine component as stated in the package circulars

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

Search/NCT00130832
NCT00130832Phase 3Completed
CompareCT.gov

Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants

Merck Sharp & Dohme LLC·interventional·Posted Aug 16, 2005·Updated Apr 1, 2015

In Brief

A Phase 3 clinical trial evaluating Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Oral Poliovirus Vaccine (OPV), and 1 other intervention for Rotavirus Infections and Gastroenteritis. Completed, enrolled 735 participants.

Detailed Summary

The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2005
Enrollment StartOct 1, 2005
Primary CompletionJul 1, 2006
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 20.9 years ago

Interventions

Rotavirus Vaccine, Live, Oral, Pentavalentbiological

Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.

Comparator: Oral Poliovirus Vaccine (OPV)biological

Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.

Comparator: Oral Poliovirus Vaccine (OPV) (staggered)biological

Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.