To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
Phase 3
Completed
- Conditions
- Infections, Rotavirus
- Registration Number
- NCT00345956
- Lead Sponsor
- GlaxoSmithKline
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 375
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of GSK's HRV liquid vaccine in eliciting immune responses against rotavirus in infants?
How does the immunogenicity of GSK's HRV liquid vaccine compare to standard-of-care rotavirus vaccines in low-resource settings like Vietnam?
Are there specific biomarkers that correlate with enhanced safety or efficacy profiles of live attenuated rotavirus vaccines in co-administered EPI regimens?
What adverse events are associated with GSK's HRV vaccine in infants and how do they compare to placebo-controlled trials in Southeast Asia?
What is the therapeutic landscape for rotavirus vaccines in Vietnam, including competitor drugs and combination approaches with other EPI vaccines?
Trial Locations
- Locations (1)
GSK Investigational Site
🇻🇳Nhatrang, Vietnam
GSK Investigational Site🇻🇳Nhatrang, Vietnam