NCT00836498

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

V260-027 Safety and Immunogenicity of RotaTeq™ in Elderly Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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.
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.
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

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-02-04
• Last updated: 2015-05-01
• Results posted: 2011-02-04