Status:
TERMINATED
A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Rotavirus
Eligibility:
All Genders
65-80 years
Phase:
PHASE1
Brief Summary
This is a Phase I clinical trial including 2 parts to evaluate the safety and immune response to RotaTeq™ /placebo in subjects of 65 to 80 years of age. In Part I, approximately 60 subjects in US will...
Eligibility Criteria
Inclusion
- Is 65 to 80 years of age with controlled chronic illness
- agrees to participate in the study by giving written informed consent and cognitively competent as assessed by Mini-Mental State Examination
- for Part I: subject is living independently outside any long-term care facilities; for Part II: subject is expected to be a resident in a long term care facility (LTCF) including nursing homes with the exception of hospice care
- can be adequately followed for safety via visit or phone
- subject's routine safety lab results are within specified ranges
- has negative test results for HIV, Hepatitis B, and Hepatitis C
Exclusion
- abdominal cancer/surgery within the past 6 months
- known or suspected immune diseases, e.g. diabetes
- any chronic or relapsing infections
- a fever at the time of immunization
- active vomiting or diarrhea at the time of immunization
- chronic diarrhea, irritable bowel syndrome, or inflammatory disease of intestinal or colon in the past 12 months
- subjects' spouses/cohabitants are not healthy or are immunocompromised; roommates in LTCFs are not healthy and/or do not agree to participate in the study
- cannot be adequately followed for safety via visit or phone
- any other clinically significant conditions that, in the investigators' opinion, would interfere with subject's participation in the study
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00836498
Start Date
January 1 2009
End Date
January 1 2010
Last Update
May 1 2015
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