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

Merck Sharp & Dohme LLC180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

180

Conditions

Herpes Zoster Shingles

Interventions

Zoster Vaccine LiveBIOLOGICAL

Zoster vaccine live

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 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.

Time frame: Up to 42 days postvaccination

Percentage of Participants Discontinued Due to Clinical Adverse Experiences

Time frame: Up to 42 days postvaccination

Data from ClinicalTrials.gov

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