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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_010 |
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The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZOSTAVAX™ / Placebo | Experimental | Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2) |
|
| Placebo / ZOSTAVAX™ | Experimental | Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoster vaccine live (ZOSTAVAX™) | Biological | 1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event | To Day 28 postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination | 4 weeks postvaccination |
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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 |
|---|---|---|---|
| 20416263 | Result | Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21. |
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Patients were recruited at 9 sites in the United States.
First patient enrolled: May-2006; Last patient last visit: July - 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | ZOSTAVAX™ / Placebo | 0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2) |
| FG001 | Placebo / ZOSTAVAX™ | 0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ZOSTAVAX™ / Placebo | 0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2) |
| BG001 | Placebo / ZOSTAVAX™ |
| 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 | Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event | All vaccinated participants were evaluated for safety. This was a crossover study. All participants received one dose each of ZOSTAVAX™ and placebo. Data below reflect SAEs reported after receipt of ZOSTAVAX™ or placebo. | Posted | Number | Participants | To Day 28 postvaccination |
|
Day 1 - 28 following each vaccination
Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period.
The participants at risk are ITT population with follow-up.
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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 | ZOSTAVAX™ | All participants that received ZOSTAVAX™ from both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group. Two participants that received ZOSTAVAX™ were lost to follow up and not included in the analysis. |
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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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|
| Comparator: Placebo | Biological | 1 dose 0.65 mL/dose subcutaneous injection of placebo. |
|
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination |
GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination |
| From prevaccination (baseline) to 4 weeks postvaccination |
| NOT COMPLETED |
|
0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 |
| Placebo |
Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included. |
|
|
| Secondary | Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination | Per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 4 weeks postvaccination |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination | GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination | Per-protocol population | Posted | Number | 95% Confidence Interval | Geometric mean fold rise | From prevaccination (baseline) to 4 weeks postvaccination |
|
|
|
| 0 |
| 98 |
| 45 |
| 98 |
| EG001 | Placebo | All participants that received Placebo in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™. Five participants that received placebo were lost to follow up and not included in the analysis. | 0 | 96 | 4 | 96 |
| Injection Site Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |