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| ID | Type | Description | Link |
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| 2004_075 |
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This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.
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| Label | Type | Description | Intervention Names |
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| 1 | Experimental | Higher Potency Dose |
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| 2 | Experimental | Lower Potency Dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Varicella Zoster Virus Vaccine | Biological | Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) | The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level. | Day 1-42 post vaccination |
| Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) | Day 1-5 postvaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions | Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be varicelliform rash by the study physician and polymerase chain reaction (PCR). | Day 1-42 postvaccination |
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 |
|---|---|---|---|
| 17227688 | Background | Tyring SK, Diaz-Mitoma F, Padget LG, Nunez M, Poland G, Cassidy WM, Bundick ND, Li J, Chan IS, Stek JE, Annunziato PW; Protocol 009 Study Group. Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age. Vaccine. 2007 Feb 26;25(10):1877-83. doi: 10.1016/j.vaccine.2006.10.027. Epub 2006 Oct 30. |
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Participants were recruited at 18 sites in the United States, Canada, and Europe
Prime Therapy Period: 30-Oct-2003 to 07-Jun-2004
Cutoff date for in-house data: 24-Aug-2004
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoster Vaccine Higher Potency | Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection |
| FG001 | Zoster Vaccine Lower Potency |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: Varicella Zoster Virus Vaccine | Biological | Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (~58,000 plaque-forming units [PFU]/0.65-mL dose) |
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| Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes | Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be zosteriform rash by the study physician and polymerase chain reaction (PCR). | Day 1-42 postvaccination |
| Number of Participants With Fevers ≥101.0°F [≥38.3°C] | Maximum reported oral or equivalent temperature ≥101.0°F [≥38.3°C] was reported Day 1 through Day 21 postvaccination. | Day 1-21 postvaccination |
Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
| Vaccinated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoster Vaccine Higher Potency | Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection |
| BG001 | Zoster Vaccine Lower Potency | Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) | The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level. | The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data. | Posted | Number | Participants | Day 1-42 post vaccination |
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| Primary | Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) | The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data. | Posted | Number | Participants | Day 1-5 postvaccination |
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| Other Pre-specified | Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions | Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be varicelliform rash by the study physician and polymerase chain reaction (PCR). | The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data. | Posted | Number | Participants | Day 1-42 postvaccination |
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| Other Pre-specified | Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes | Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be zosteriform rash by the study physician and polymerase chain reaction (PCR). | The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data. | Posted | Number | Participants | Day 1-42 postvaccination |
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| Other Pre-specified | Number of Participants With Fevers ≥101.0°F [≥38.3°C] | Maximum reported oral or equivalent temperature ≥101.0°F [≥38.3°C] was reported Day 1 through Day 21 postvaccination. | The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data. 5 participants in the Zoster Vaccine Higher Potency group and 3 participants in the Zoster Vaccine Lower Potency group were not included in this analysis since these participants were without a follow-up. | Posted | Number | Participants | Day 1-21 postvaccination |
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Day 1 - 42 postvaccination
Daily temperature readings, injection-site adverse experiences, rashes, and other adverse experiences were recorded by the participant on a Vaccination Report Card which was reviewed 42 days after vaccination.
Number of participants at risk included randomized participants who had follow-up after at least one dose of 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) |
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| EG000 | Zoster Vaccine Higher Potency | Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection | 4 | 459 | 296 | 459 | ||
| EG001 | Zoster Vaccine Lower Potency | Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection | 1 | 234 | 141 | 234 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Angina pectoris | Cardiac disorders | MedDRA Version 7.0 | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA Version 7.0 | Non-systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA Version 7.0 | Non-systematic Assessment |
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| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 7.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 7.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Headache | Nervous system disorders | MedDRA Version 7.0 | Non-systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA Version 7.0 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA Version 7.0 | Systematic Assessment |
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| Injection Site Pruritus | General disorders | MedDRA Version 7.0 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA Version 7.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
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| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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