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Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

NCT02542462 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2018-07-12

Study results available
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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.

Conditions

  • Intussusception
  • Rotavirus Infections

Interventions

DRUG

Rotarix®,

Single oral dose of licensed rotavirus vaccine given alone

DRUG

Rotarix®, with other routine vaccines

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

DRUG

RotaTeq®,

Single oral dose of licensed rotavirus vaccine given alone

DRUG

RotaTeq®, with other routine vaccines

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

Sponsors & Collaborators

Principal Investigators

  • Mary A. Staat, MD, MPH · Children's Hospital Medical Center, Cincinnati

  • Karen Broder, MD · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02542462 on ClinicalTrials.gov