Back to resultsZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
Primary Purpose
Herpes Zoster, Shingles
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zoster Vaccine Live
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Zoster
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zoster Vaccine Live
Arm Description
Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Outcomes
Primary Outcome Measures
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).
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
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.
Percentage of Participants Discontinued Due to Clinical Adverse Experiences
Secondary Outcome Measures
Full Information
NCT ID
NCT01556451
First Posted
February 17, 2012
Last Updated
March 14, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01556451
Brief Title
ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster, Shingles
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zoster Vaccine Live
Arm Type
Experimental
Arm Description
Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Intervention Type
Biological
Intervention Name(s)
Zoster Vaccine Live
Other Intervention Name(s)
ZOSTAVAX™, V211
Intervention Description
Zoster vaccine live
Primary Outcome Measure Information:
Title
Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody
Description
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
Title
Geometric Mean Titer (GMT) of VZV Antibody
Description
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
Title
Percentage of Participants With Clinical Adverse Experiences
Description
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
Title
Percentage of Participants Discontinued Due to Clinical Adverse Experiences
Time Frame
Up to 42 days postvaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
26770032
Citation
Choi WS, Choi JH, Choi JY, Eom JS, Kim SI, Pai H, Peck KR, Sohn JW, Cheong HJ. Immunogenicity and Safety of a Live Attenuated Zoster Vaccine (ZOSTAVAX) in Korean Adults. J Korean Med Sci. 2016 Jan;31(1):13-7. doi: 10.3346/jkms.2016.31.1.13. Epub 2015 Dec 24.
Results Reference
result
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ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
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