A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

Study Overview
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Brief Summary
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The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.

Detailed Description
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The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age in Hongkong and Taiwan or 11-17 weeks of age in Singapore, according to a 0, 1 to 2-month schedule. Routine vaccinations are given concomitantly with the study vaccines at 2 or 3 and 4 months of age according to each local country regulation. Whenever OPV is used, a minimum 2-week interval should be observed between HRV vaccine and OPV doses.

Official Title
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A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Biological: Rotavirus


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol. 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 of immunosuppressants or other immune-modifying drugs since birth. Child is unlikely to remain in the study area during 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. First or second degree of consanguinity of parents.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 17 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Rotavirus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe RV GE by wild-type G1, non-G1, each non-G1 and severe GE from 2 weeks after Dose 1 and 2 until 2-year old. SAEs. Mortality. Definite IS until 2-years old. Serum anti-RV IgA at Visits 1 and 3 (100 subjects/country). |  |  |