Status:
COMPLETED
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
11-17 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2003
Estimated Enrollment :
2464 Patients enrolled
Trial Details
Trial ID
NCT00429481
Start Date
January 1 2001
End Date
April 1 2003
Last Update
September 16 2016
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