A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.

Detailed Description
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The duration of treatment is 4 weeks.

Official Title
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A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)

Conditions
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Herpes Zoster

Intervention / Treatment
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* Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
* Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who are at least 50 years of age or older with a history of varicella (chicken pox) Exclusion Criteria: Prior history of herpes zoster (shingles) Prior receipt of varicella or zoster vaccine Immunosuppressed

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zoster vaccine live (Oka/Merck) refrigerated formulation<br>ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer ( 45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection | Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation<br>* 1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1<br>|
| Active Comparator: zoster vaccine live (Oka/Merck) frozen formulation<br>ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer ( 57,000 PFU), 1 subcutaneous 0.65-mL injection | Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation<br>* 1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1<br>|

What is the study measuring?
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Primary 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 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 4 weeks |