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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_017 |
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The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).
The duration of treatment is 12 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoster vaccine live (Oka/Merck) | Biological |
| ||
| Comparator: placebo (unspecified) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| VZV ELISPOT response ~6 weeks after 1 and 2 doses | 6 weeks after 1 and 2 doses |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo | 1 through 3 years after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22154769 | Result | Vermeulen JN, Lange JM, Tyring SK, Peters PH, Nunez M, Poland G, Levin MJ, Freeman C, Chalikonda I, Li J, Smith JG, Caulfield MJ, Stek JE, Chan IS, Vessey R, Schodel FP, Annunziato PW, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >/=60 years of age. Vaccine. 2012 Jan 20;30(5):904-10. doi: 10.1016/j.vaccine.2011.11.096. Epub 2011 Dec 7. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsiis | View IPD |
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| 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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| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |