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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001030-29 | EudraCT Number |
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The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V212 Lot 1 | Experimental | Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart |
|
| V212 Lot 2 | Experimental | Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart |
|
| V212 Lot 3 | Experimental | Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V212 Lot 1 | Biological | Inactivated Varicella Zoster Virus vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers | 28 days postdose 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a Serious Adverse Experience | Up to 28 days postdose 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37781954 | Derived | de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5. |
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| V212 Lot 2 |
| Biological |
Inactivated Varicella Zoster Virus vaccine |
|
| V212 Lot 3 | Biological | Inactivated Varicella Zoster Virus vaccine |
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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 |
| D007239 | Infections |
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