NCT00289172

Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India

A Multicenter Study of the Immunogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (RIX4414) as Primary Dosing of Healthy Infants in India Aged Approximately 8 Wks at the Time of the First Dose

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose.

Detailed description

The study consists of two groups of children to be recruited in different centers in India. One group will receive the HRV vaccine and one group will receive the placebo. The vaccine or placebo will be administered starting at 8-12 weeks of age, according to a two dose schedule (0, 1 months schedule). The study will consist of three visits. A 8-day (Day 0 - 7) follow-up period will be observed for general symptoms solicited in the study. A 31-day (Day 0 - 30) follow-up will be observed for other unsolicited symptoms. Serious adverse events (SAEs) will be followed-up throughout the study. A stool sample will be collected from the child at any point during the study if he/ she develops any GE.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated human rotavirus vaccine

Timeline

• Start date: 2006-02-10
• Completion: 2006-09-08
• First posted: 2006-02-09
• Last updated: 2017-05-30

Locations

4 sites across 1 country: India