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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00345956

Enrollment

375

Registered

2006-06-29

Start date

2006-09-30

Completion date

2007-03-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Rotavirus

Keywords

Prophylaxis against gastroenteritis caused by Rotavirus

Brief 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

Interventions

BIOLOGICALHuman rotavirus liquid vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 10 Weeks

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.

Design outcomes

Primary

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

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026