NCT00429481CompletedPhase 2
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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 2,464
- Primary Endpoint
- Occurrence of any RV GE
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 11 Weeks to 17 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Occurrence of any RV GE
Secondary Outcomes
- Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study),
Investigators
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