NCT00396630

A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 14 Weeks
• Healthy volunteers: Accepted

Summary

The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator. One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study. The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo. The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix	Two-dose oral vaccination.
BIOLOGICAL	Placebo	Two-dose oral administration.

Timeline

• Start date: 2007-01-23
• Primary completion: 2008-01-23
• Completion: 2008-02-13
• First posted: 2006-11-07
• Last updated: 2018-02-06
• Results posted: 2009-03-13

Locations

1 site across 1 country: Dominican Republic

Regulatory

• FDA-regulated drug study