A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Rotavirus

Treatments: Biological: Comparator: RotaTeq + Placebo; Biological: Comparator: Placebo; Biological: Comparator: RotaTeq

Study type: Interventional

Funder types: Industry

Identifiers

NCT00836498

2007_537

V260-027

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 5 patient groups, including a placebo group

Part I, RotaTeq

Experimental group

Description:

3 doses of RotaTeq

Treatment:

Biological: Comparator: RotaTeq

Part I, placebo

Placebo Comparator group

Description:

3 doses of placebo

Treatment:

Biological: Comparator: Placebo

Part II, RotaTeq

Experimental group

Description:

3 doses of RotaTeq

Treatment:

Biological: Comparator: RotaTeq

Part II, RotaTeq and placebo

Experimental group

Description:

1 dose of RotaTeq and 2 doses of placebo

Treatment:

Biological: Comparator: RotaTeq + Placebo

Part II, placebo

Placebo Comparator group

Description:

3 doses of placebo

Treatment:

Biological: Comparator: Placebo