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Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana

NCT01575197 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2015-06-01

Study results available
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Summary

The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.

Conditions

  • Rotavirus Gastroenteritis

Interventions

BIOLOGICAL

Human Rotavirus Vaccine

Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 \& 10 weeks of age, 10 \& 14 weeks of age, or 6, 10, \& 14 weeks of age, depending on study arm assignment.

Sponsors & Collaborators

Principal Investigators

  • George Armah, PhD · Noguchi Memorial Institute for Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Ghana

Study Locations

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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 NCT01575197 on ClinicalTrials.gov