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

Phase 3

Completed

• Conditions: Infections, Rotavirus

• Registration Number: NCT00289172
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-02-08
• Study First Submitted QC: 2006-02-08
• Study First Posted: 2006-02-09
• Study Start: 2006-02-10
• Study Completion: 2006-09-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-26
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.

Secondary Outcome Measures

Name	Time	Method
Fever, vomiting, diarrhea. Solicited symptoms. Unsolicited events. SAEs. Presence of rotavirus in GE stools.

Trial Locations

Locations (1)

GSK Investigational Site; 🇮🇳 Vellore,, India