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.
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