A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)
Condition: Rotavirus
Intervention: Comparator: RotaTeq; Comparator: Placebo; Comparator: RotaTeq + Placebo
Intervention description: Three 2.0 mL oral doses of RotaTeq. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.; Three 2.0 mL oral doses of RotaTeq. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.; One 2.0 mL oral dose of RotaTeq and two 2.0 mL oral doses of placebo over an approximately 3-5 month treatment period
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 65 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

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 be randomly assigned to 1 of 2 treatment groups receiving 3 doses of
      RotaTeq™ or placebo. In Part II, approximately 200 subjects internationally will be randomly
      assigned to 1 of 3 treatment groups. Part II will start after Part I data analysis is
      reviewed and approved by the FDA/CBER, the Safety Evaluation Committee (SEC) and other
      regulatory agencies. Duration for the entire study will be approximately 4 years.

      Note: As the result of a business decision by the Sponsor, the study did not proceed with
      Part II. Therefore, this report includes the results for Part I only.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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