None listed
Conditions
Interventions
Oral Live Attenuated Human Rotavirus Type of group
Two oral doses administered to healthy infants who are 6-13 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country. A minimum 2-week interval was to be observed between HRV vaccine and OPV doses.
Group name:Placebo Type of group
Vaccinated human rotavirus vaccine placebo will be administered orally.
Sponsors
GlaxoSmithKline,
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 rotavirus gastroenteritis. Measure:Occurrence of severe GE RV caused by wild VR strains during the period starting from 2 weeks after dose 2 until year of age. Timepoints:2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Occurrence of rotavirus gastroenteritis. Measure:Severe RV GE in subset during the 2nd year and both years Timepoints:second year | — |
Countries
Argentina, Brazil, Chile, Colombia, Dominican Republic, Finland, Honduras, Mexico, Nicaragua, Panama, Peru, Venezuela
Outcome results
None listed