Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)

Phase 2

Completed

• Conditions: Shingles

• Registration Number: NCT00109122
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).

Detailed Description

The duration of treatment is 12 weeks.

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2003-02
• Study First Submitted: 2005-04-22
• Study First Submitted QC: 2005-04-22
• Study First Posted: 2005-04-25
• Study Completion: 2006-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Individuals who are at least 60 years of age with a history of varicella (shingles)
• Females must have been postmenopausal.

Exclusion Criteria

• Subjects who did not previously participate in the main study of this protocol.
• Subject had shingles since their 6 month follow-up visit in main phase of study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VZV ELISPOT response ~6 weeks after 1 and 2 doses	6 weeks after 1 and 2 doses

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo	1 through 3 years after vaccination