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

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.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Shingles Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoster Vaccine Live

Biological

Zoster vaccine live

Other names: ZOSTAVAX™, V211

Primary outcomes

Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody

Time frame: Day 1 (Baseline) and Week 4 postvaccination

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).
Geometric Mean Titer (GMT) of VZV Antibody

Time frame: Day 1 (Baseline) and 4 weeks postvaccination

Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV
Percentage of Participants With Clinical Adverse Experiences

Time frame: Up to 42 days postvaccination

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.
Percentage of Participants Discontinued Due to Clinical Adverse Experiences

Time frame: Up to 42 days postvaccination

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Mar 16, 2012
Registry last updated: Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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