Herpes Zoster
Conditions
Interventions
ZOSTAVAX* or placebo will be administered as a ~0.65-mL subcutaneous injection,
preferably in the deltoid region of the nondominant arm.
Sponsors
Merck
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects reporting serious clinical adverse experiences through Day 42 postvaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects reporting serious clinical adverse experiences during the entire 6-month postvaccination follow-up period. | — |
Countries
Netherlands
Outcome results
None listed