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

NCT ID: NCT00836498

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

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 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.

Conditions

Rotavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Part I, RotaTeq

3 doses of RotaTeq

Group Type: EXPERIMENTAL

Comparator: RotaTeq

Intervention Type: BIOLOGICAL

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.

Part I, placebo

3 doses of placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: BIOLOGICAL

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.

Part II, RotaTeq

3 doses of RotaTeq

Group Type: EXPERIMENTAL

Comparator: RotaTeq

Intervention Type: BIOLOGICAL

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.

Part II, RotaTeq and placebo

1 dose of RotaTeq and 2 doses of placebo

Group Type: EXPERIMENTAL

Comparator: RotaTeq + Placebo

Intervention Type: BIOLOGICAL

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

Part II, placebo

3 doses of placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: BIOLOGICAL

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.

Interventions

Comparator: RotaTeq

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.

Intervention Type: BIOLOGICAL

Comparator: Placebo

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.

Intervention Type: BIOLOGICAL

Comparator: RotaTeq + Placebo

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Lawrence J, He S, Martin J, Schodel F, Ciarlet M, Murray AV. Safety and immunogenicity of pentavalent rotavirus vaccine in a randomized, double-blind, placebo-controlled study in healthy elderly subjects. Hum Vaccin Immunother. 2014;10(8):2247-54. doi: 10.4161/hv.29107.

Reference Type: RESULT

PMID: 25424929 (View on PubMed)

Other Identifiers

2007_537

Identifier Type: -

Identifier Source: secondary_id

V260-027

Identifier Type: -

Identifier Source: org_study_id