NL-OMON31293
Withdrawn
Phase 4
A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX in Subjects >=60 Years of Age - Safety and Tolerability of ZOSTAVAX in Subjects >=60 Years of Age
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Herpes Zoster
- Sponsor
- Merck
- Enrollment
- 750
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(see protocol page 20 for complete text of criteria);\- Age \>\=60 Years
- •\- Signed informed consent form
- •\- Afebrile on day of vaccination
- •\- Females must be postmenopausal or have negative pregnancy test
Exclusion Criteria
- •(see protocol page 20 for complete text of criteria);1\. A history of allergic reaction to any vaccine component
- •2\. Prior receipt of any varicella or zoster vaccine.
- •3\. Any live virus vaccine administered within 4 weeks prevaccination or scheduled
- •during the 42\-day postvaccination period.
- •4\. Any inactivated vaccine, except for influenza vaccine, administered within 7 days
- •prevaccination or scheduled during the 42\-day postvaccination period
- •5\. Subject is pregnant or breastfeeding.
- •6\. Participation in an investigational drug or vaccine study within the last 30 days prior to enrollment or expected during the 42\-day postvaccination period.
- •7\. An intercurrent illness (including active untreated tuberculosis) that might interfere with the interpretation of the study
- •8\. Use of immunosuppressive therapy.
Outcomes
Primary Outcomes
Not specified
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