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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00345956

Purpose

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

Condition	Intervention	Phase
Gastroenteritis Rotavirus Infection	Biological: Human rotavirus liquid vaccine	Phase III

MedlinePlus related topics: Gastroenteritis Rotavirus Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Placebo-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Bio Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine, When Given to Healthy Infants, in Vietnam

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs

Estimated Enrollment:	375
Study Start Date:	September 2006

Eligibility

Ages Eligible for Study:	6 Weeks to 10 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345956

Locations

Vietnam
GSK Investigational Site
Hanoi, Vietnam, 084
GSK Investigational Site
Nhatrang, Vietnam, 084

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	105722
Study First Received:	June 28, 2006
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00345956
Health Authority:	Vietnam: Ministry of Health

Keywords provided by GlaxoSmithKline:

Prophylaxis against gastroenteritis caused by Rotavirus

Study placed in the following topic categories:

Virus Diseases
Digestive System Diseases
Rotavirus Infections

Gastrointestinal Diseases
Healthy
Gastroenteritis

Additional relevant MeSH terms:

RNA Virus Infections
Reoviridae Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009