A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.
- Registration Number
- PER-064-03
- Lead Sponsor
- GLAXOSMITHKLINE BIOLOGICALS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Healthy infants 6-13 weeks of age at the time of the first study vaccination whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits)
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
Child is unlikely to remain in the study area for the duration of the study
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Occurrence of severe GE RV caused by wild VR strains during the period starting from 2 weeks after dose 2 until year of age. 2. Occurrence of definite cases of SI within 31 days (Day 0 - Day 30) after each dose of vaccination against HRV.<br>Measure:Safety of the RVH vaccine of GSK Biologicals with respect to intussusception (IS) in 31 days (Day 0-Day 30) after each dose of RVH vaccine (administered at 2 and 4 months of age).<br>Timepoints:day 30<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Severe RV GE by wild type G1, not G1, each not G1, 11 score after dose 2 and dose 1 until 1 year of age.<br>Measure:To evaluate whether two doses of RVH vaccine from GSK Biologicals can prevent severe GE RV caused by the natural strain of RV serotype G1 during the period starting 2 weeks after Dosage 2 until the year of age.<br>Timepoints:day 30<br>