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

Study Overview
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Brief Summary
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To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.

Official Title
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Study to Assess Efficacy, Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at Different Viral Concentrations in Healthy Infants Previously Uninfected With Human Rotavirus and Approximately 3 Months of Age.

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Rotarix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks). Written informed consent obtained from the parents or guardians of the subject. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib. 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 including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). Household contact with an immunosuppressed individual or pregnant woman. Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Previous confirmed occurrence of RV GE.

Ages Eligible for Study
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Minimum Age: 11 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: 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 any RV GE |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study), |  |  | 

 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, Vomiting