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| ID | Type | Description | Link |
|---|---|---|---|
| MKV211-019 | |||
| 2007_008 |
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The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Zostavax |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine, Live, (Oka-Merck) | Biological | A single dose of 0.65 ml of Zostavax injection was given to each study subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed. | prevaccination and 4 weeks postvaccination |
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Inclusion Criteria:
Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent
All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test
A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination
Subject Must Sign Informed Consent Prior To Any Study Procedure
Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination
Any Underlying Chronic Illness Must Be In Stable Condition
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25681662 | Result | Yao CA, Chen LK, Huang KC. The immunogenicity and safety of zoster vaccine in Taiwanese adults. Vaccine. 2015 Mar 24;33(13):1515-7. doi: 10.1016/j.vaccine.2015.01.085. Epub 2015 Feb 11. |
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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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| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |