Status:
COMPLETED
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Vomiting
Diarrhea
Eligibility:
All Genders
4-12 years
Phase:
PHASE3
Brief Summary
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.
Eligibility Criteria
Inclusion
- Age 4 weeks through 12 weeks at Dose 1
- Parent able to understand study procedures and give consent
Exclusion
- Clinical evidence of active gastrointestinal disease
- Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
7504 Patients enrolled
Trial Details
Trial ID
NCT00362648
Start Date
March 1 2007
End Date
March 1 2009
Last Update
April 13 2017
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