None listed
Conditions
Interventions
Live human rotavirus oral vaccine attenuated Type of group
Vaccination schedule: Two oral doses will be administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0 - 2 month schedule.
Sponsors
GLAXOSMITHKLINE BIOLOGICALS,
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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). Timepoints:day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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. Timepoints:day 30 | — |
Countries
Brazil, Costa Rica, Mexico, Peru, United States, Venezuela
Contacts
Public ContactClaudio Franco Lanata
INSTITUTO DE INVESTIGACION NUTRICIONAL
Outcome results
None listed