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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoster Vaccine Live | Experimental | Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine Live | Biological | Zoster vaccine live |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | 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. | Up to 42 days postvaccination |
| Percentage of Participants Discontinued Due to Clinical Adverse Experiences | Up to 42 days postvaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26770032 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoster Vaccine Live | Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoster Vaccine Live | Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (Baseline) and Week 4 postvaccination |
|
Up to 42 days postvaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zoster Vaccine Live | Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal Fistula | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-Site Erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | 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 | The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 (Baseline) and 4 weeks postvaccination |
|
|
|
| Primary | 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. | Safety population which included all vaccinated participants who had any safety follow-up | Posted | Number | Percentage of Participants | Up to 42 days postvaccination |
|
|
|
| Primary | Percentage of Participants Discontinued Due to Clinical Adverse Experiences | Safety population which included all vaccinated participants who had any safety follow-up | Posted | Number | Percentage of Participants | Up to 42 days postvaccination |
|
|
|
| 3 |
| 180 |
| 96 |
| 180 |
| Gastric Polyps | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Injection-Site Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection-Site Swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |