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A Phase IIb Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids
The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 309 |
| Start date | 2007-10 |
| Completion | 2010-08 |
Conditions
- Herpes Zoster
Interventions
- Zoster Vaccine, Live
- Comparator: Placebo
Primary outcomes
- Number of Participants With Serious Adverse Events (SAE) — Up to 182 days postvaccination
A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.