Clinical Trials Directory

Trials / Completed

CompletedNCT00345956

To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)

A Placebo-controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine, When Given to Healthy Infants, in Vietnam

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
375 (estimated)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
6 Weeks – 10 Weeks
Healthy volunteers
Accepted

Summary

To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo

Conditions

Interventions

TypeNameDescription
BIOLOGICALHuman rotavirus liquid vaccine

Timeline

Start date
2006-09-01
Completion
2007-03-01
First posted
2006-06-29
Last updated
2016-10-28

Locations

2 sites across 1 country: Vietnam

Source: ClinicalTrials.gov record NCT00345956. Inclusion in this directory is not an endorsement.