ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01556451|
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : September 23, 2013
Last Update Posted : April 12, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster Shingles||Biological: Zoster Vaccine Live||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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
Primary Outcome Measures :
- 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 ]
No Contacts or Locations Provided