A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX in Subjects >=60 Years of Age
- Conditions
- Herpes Zostershingles10047438
- Registration Number
- NL-OMON31293
- Lead Sponsor
- Merck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 750
(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
(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.
9. Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Subjects with a history of cancer who are not on active treatment and are not thought to be immunosuppressed at enrollment will be eligible for enrollment.
10. Any concomitant use of nontopical antiviral therapy with activity against
herpesviruses.
11. Any other reason that in the opinion of the investigator might interfere with the
evaluation required by the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of subjects reporting serious clinical adverse experiences<br /><br>through Day 42 postvaccination.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The proportion of subjects reporting serious clinical adverse experiences<br /><br>during the entire 6-month postvaccination<br /><br>follow-up period.</p><br>