Status:
COMPLETED
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2001
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00425737
Start Date
August 1 2000
End Date
July 1 2001
Last Update
September 16 2016
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