A Phase 4 interventional study of Zoster Vaccine Live in Herpes Zoster and Shingles, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 4, Interventional, and Prevention
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.
370 studies on the registry are indexed under Herpes Zoster; 63 are open to participants now.
This study's enrollment of 180 is below the median of 242 across 306 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
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Exclusion Criteria:
Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Biological: Zoster Vaccine Live
Zoster vaccine live
Also known as: ZOSTAVAX™, V211
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
| Milestone | Zoster Vaccine Live |
|---|---|
| Started | 180 |
| Completed | 180 |
| Not completed | 0 |
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).
| Ratio | Zoster Vaccine Live |
|---|---|
| Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody | 2.8 (2.5 to 3.1) |
Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV
| gpELISA units/mL | Zoster Vaccine Live |
|---|---|
| Day 1 (Baseline) | 66.9 (59.2 to 75.5) |
| Week 4 postvaccination | 185.4 (167.0 to 205.9) |
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 | Zoster Vaccine Live |
|---|---|
| Injection site adverse experiences | 53.3 |
| Non-injection site adverse experiences | 24.4 |
| Percentage of Participants | Zoster Vaccine Live |
|---|---|
| Percentage of Participants Discontinued Due to Clinical Adverse Experiences | 0 |
Collected over Up to 42 days postvaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zoster Vaccine Live | — | 3/180 (1.7%) | 96/180 (53.3%) |
| Event | Zoster Vaccine Live |
|---|---|
| Anal FistulaGastrointestinal disorders | 1/180 |
| Gastric PolypsGastrointestinal disorders | 1/180 |
| Spinal Compression FractureInjury, poisoning and procedural complications | 1/180 |
| Event | Zoster Vaccine Live |
|---|---|
| Injection-Site ErythemaGeneral disorders | 81/180 |
| Injection-Site SwellingGeneral disorders | 68/180 |
| Injection-Site PainGeneral disorders | 50/180 |
| Age, Customized(Participants) | Zoster Vaccine Live |
|---|---|
| Between 50 and 59 years | 89 |
| 60 years or older | 91 |
| Sex: Female, Male(Participants) | Zoster Vaccine Live |
|---|---|
| Female | 136 |
| Male | 44 |
No study locations are listed for this record.
Plan to share: Yes — 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
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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