A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
- Conditions
- Herpes Zoster
- Registration Number
- NCT00322231
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment
- History of allergy to any vaccine component
- Prior receipt of a varicella or zoster vaccine
- Ability to defend against infection is suppressed by a medical condition or medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination To Day 28 postvaccination SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
- Secondary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination 4 weeks postvaccination The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination From prevaccination (baseline) to 4 weeks postvaccination GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination