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COMPLETEDPHASE3

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

NCT00345956•GlaxoSmithKline

View on ClinicalTrials.gov

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

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of \> 2000 grams.
•Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
•Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.

Locations (2)

GSK Investigational Site

Hanoi, Vietnam

GSK Investigational Site

Nhatrang, Vietnam

Key Dates

Start Date

September 1, 2006

Completion Date

March 1, 2007

Last Updated

October 28, 2016

Enrollment

375

ESTIMATED participants

Conditions

Infections, Rotavirus

Interventions

Human rotavirus liquid vaccine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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