CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 144 enrolled
Drug / intervention
Rotarix®, +3 moredrug
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.

Search/NCT02542462
NCT02542462Phase 4Completed
CompareCT.gov

Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

Children's Hospital Medical Center, Cincinnati·interventional·Posted Sep 7, 2015·Updated Jul 12, 2018

In Brief

A Phase 4 clinical trial evaluating Rotarix®,, Rotarix®, with other routine vaccines, and 2 other interventions for Intussusception and Rotavirus Infections. Completed, enrolled 144 participants across 1 site.

Detailed Summary

This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntussusception, Rotavirus Infections
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 7, 2015
Enrollment StartNov 1, 2015
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.8 years ago

Interventions

Rotarix®,drug

Single oral dose of licensed rotavirus vaccine given alone

Rotarix®, with other routine vaccinesdrug

Single oral dose of licensed rotavirus vaccine given with other routine vaccines

RotaTeq®,drug

Single oral dose of licensed rotavirus vaccine given alone

RotaTeq®, with other routine vaccinesdrug

Single oral dose of licensed rotavirus vaccine given with other routine vaccines