NCT01575197

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 42 Days – 55 Days
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-04-11
• Last updated: 2015-06-01
• Results posted: 2015-06-01

Locations

1 site across 1 country: Ghana