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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_017 |
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This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V710 | Experimental | V710 vaccination (60 mcg) single dose on Day 1 |
|
| Placebo | Placebo Comparator | Placebo single dose on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V710 | Biological | V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level | Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers. | Baseline (Day 1) to Day 14 postvaccination |
| Number of Participants With Vaccine-related Serious Adverse Experiences | Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related. | Baseline (Day 1) to Day 84 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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| ID | Title | Description |
|---|---|---|
| FG000 | V710 | V710 vaccination (60 mcg) single dose on Day 1 |
| FG001 | Placebo | Placebo single dose on Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V710 | V710 vaccination (60 mcg) single dose on Day 1 |
| BG001 | Placebo | Placebo single dose on Day 1 |
| 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 | Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level | Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day 1) to Day 14 postvaccination |
|
|
Day 1 through Day 14 postvaccination
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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 | V710 | V710 vaccination (60 mcg) single dose on Day 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA (11.0) |
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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 |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C579630 | V710 vaccine |
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| Placebo |
| Biological |
Saline placebo (0.5 ml) single injection on Day 1 |
|
| BG002 |
| Total |
Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Number of Participants With Vaccine-related Serious Adverse Experiences | Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related. | Posted | Number | Participants | Baseline (Day 1) to Day 84 postvaccination |
|
|
|
| 0 |
| 30 |
| 12 |
| 30 |
| EG001 | Placebo | Placebo single dose on Day 1 | 0 | 10 | 2 | 10 |
| Injection site pain | General disorders | MedDRA (11.0) |
|
| Injection site swelling | General disorders | MedDRA (11.0) |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
|
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