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| ID | Type | Description | Link |
|---|---|---|---|
| ZTV02C | Other Identifier | MCMVaccBV (SPMSD) Protocol Number | |
| 2007-006532-66 | EudraCT Number |
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Primary objective:
To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay [gpELISA]) from pre-vaccination to 4 weeks post-vaccination.
Secondary objectives:
To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled | Experimental | Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZOSTAVAX® | Biological | One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titre (GMT) of Varicella Antibodies | Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA). | Predose (Day 0) and Day 28-35 Post Dose |
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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 |
|---|---|---|---|
| 21941091 | Derived | Arnou R, Fiquet A, Thomas S, Sadorge C. Immunogenicity and safety of ZOSTAVAX((R)) approaching expiry potency in individuals aged >/=50 years. Hum Vaccin. 2011 Oct;7(10):1060-5. doi: 10.4161/hv.7.10.16480. Epub 2011 Oct 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled | Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled | Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Titre (GMT) of Varicella Antibodies | Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA). | All vaccinated participants excluding those with any protocol deviation which may have interfered with the immunogenicity evaluation and excluding participants with herpes zoster onset before the post-vaccination blood sample | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Predose (Day 0) and Day 28-35 Post Dose |
|
Up to 35 days post vaccination
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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 | V211 | All enrolled participants who received vaccination |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 10.0 | 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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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 96 |
| 50 |
| 96 |
| Injection site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
The investigator shall send to Sanofi Pasteur MSD for approval any of the publication and/or communication draft, in whatever forms (abstracts, manuscripts, texts). Sanofi Pasteur MSD shall have 60 (sixty) days to review the draft, have reserves if any, and formulate its refusal to the draft in whole or in part if the draft contains confidential data, may prejudice to Sanofi Pasteur MSD patent/intellectual property rights and/or is not compliant with the study results.
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |