ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical hypothesis testing will be conducted in the study.

Official Title
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An Open-label, Single-arm, Multi-center, Phase IV Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in Korea

Conditions
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Herpes Zoster, Shingles

Intervention / Treatment
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* Biological: Zoster Vaccine Live


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No fever on day of vaccination Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal Underlying chronic illness must be stable Exclusion Criteria: History of hypersensitivity reaction to any vaccine component Prior history of herpes zoster Prior receipt of varicella or zoster vaccine Pregnant or breastfeeding Have recently received immunoglobulins or blood products other than autologous blood transfusion Received any inactivated other live virus vaccine within 4 weeks prior to vaccination, or is expected to received any other live virus vaccine during the duration of the study Received any inactivated vaccine within 7 days prior to vaccination, or is expected to receive any inactivated vaccine during the duration of the study Use of immunosuppressive therapy Known or suspected immune dysfunction Use of nontopical antiviral therapy with activity against herpes virus Known or suspected active untreated tuberculosis

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoster Vaccine Live<br>Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1 | Biological: Zoster Vaccine Live<br>* Zoster vaccine live<br>* Other names: V211;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody | Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline). | Day 1 (Baseline) and Week 4 postvaccination | 
| Geometric Mean Titer (GMT) of VZV Antibody | Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV | Day 1 (Baseline) and 4 weeks postvaccination | 
| Percentage of Participants With Clinical Adverse Experiences | An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. | Up to 42 days postvaccination | 
| Percentage of Participants Discontinued Due to Clinical Adverse Experiences |  | Up to 42 days postvaccination |