CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 456 enrolled
Drug / intervention
Human Rotavirus Vaccinebiological
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/NCT01575197
NCT01575197Phase 4Completed
CompareCT.gov

Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana

PATH·interventional·Posted Apr 11, 2012·Updated Jun 1, 2015

In Brief

A Phase 4 clinical trial evaluating Human Rotavirus Vaccine for Rotavirus Gastroenteritis. Completed, enrolled 456 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus Gastroenteritis
CountriesGhana
CollaboratorsNoguchi Memorial Institute for Medical Research, Navrongo Health Research Centre, Ghana, Centers for Disease Control and Prevention

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2012
Enrollment StartSep 1, 2012
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.2 years ago

Interventions

Human Rotavirus Vaccinebiological

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.