A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster

Conditions
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Herpes Zoster

Intervention / Treatment
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* Biological: zoster vaccine live (ZOSTAVAX™)
* Biological: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZOSTAVAX™ / Placebo<br>Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2) | Biological: zoster vaccine live (ZOSTAVAX™)<br>* 1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live<br>* Other names: Zostavax;Biological: Comparator: Placebo<br>* 1 dose 0.65 mL/dose subcutaneous injection of placebo.<br>|
| Experimental: Placebo / ZOSTAVAX™<br>Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2) | Biological: zoster vaccine live (ZOSTAVAX™)<br>* 1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live<br>* Other names: Zostavax;Biological: Comparator: Placebo<br>* 1 dose 0.65 mL/dose subcutaneous injection of placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days 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 | To Day 28 postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 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 | 4 weeks postvaccination | 
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination | GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination | From prevaccination (baseline) to 4 weeks postvaccination |