Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants

Study Overview
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Brief Summary
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To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus

Official Title
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A Study to Assess the Efficacy, Immunogenicity and Safety of Two Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in Healthy Infants.

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Biological: Rotarix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants 6 and 12 weeks of age at the time of the first vaccination. Written informed consent obtained from the parents or guardians of the subject. Born after a normal gestation period (between 36 and 42 weeks). Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.) Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after. Any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator. 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. Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). Household contact with an immunosuppressed individual or pregnant woman. Abnormal stool pattern. Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Previous confirmed occurrence of rotavirus gastroenteritis.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 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: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of RV GE |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of severe RV GE, solicited symptoms (Day 0-14), unsolicited Adverse Events (Day 0-42), Serious Adverse Events (full study), presence of rotavirus antigen in stool samples, immunogenicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral live attenuated human rotavirus vaccine, Gastroenteritis