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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official 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|
- Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody [ Time Frame: Day 1 (Baseline) and Week 4 postvaccination ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Zoster Vaccine Live
Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Biological: Zoster Vaccine Live
Zoster vaccine live