Status:
COMPLETED
A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Rotavirus Gastroenteritis
Eligibility:
All Genders
6-47 years
Phase:
PHASE1
Brief Summary
This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts,...
Eligibility Criteria
Inclusion
- Healthy adults ages 19 to 47 years for Cohort I
- Healthy children ages 2 to 6 years for Cohort II
- Healthy infants ages 6 to 12 weeks for Cohort III
- Negative pregnancy test for females in Cohort I
- Signed Informed Consent Forms (ICFs)
Exclusion
- Participants in Cohorts I and II receiving any vaccine 14 days before or anticipated after study vaccine
- Participants in Cohort III receiving non-concomitant live vaccines 14 days before or after study vaccine
- Prior administration of any rotavirus vaccine
- Elevated temperature, with axillary temperature ≥37.1 Degrees C 24 hours before study vaccine
- Prior or active gastrointestinal illnesses, immunodeficiency
- Any condition which may interfere with evaluation of study objectives or make participation in the study unsafe for the participant
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00953056
Start Date
September 1 2009
End Date
March 1 2010
Last Update
November 2 2015
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