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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_531 |
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This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | V710 |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: V710 | Biological | Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg). | Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac). | Prevaccination to 14 days postvaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| GMFR by Age | Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac. |
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 |
|---|---|---|---|
| 22192849 | Result | Harro CD, Betts RF, Hartzel JS, Onorato MT, Lipka J, Smugar SS, Kartsonis NA. The immunogenicity and safety of different formulations of a novel Staphylococcus aureus vaccine (V710): results of two Phase I studies. Vaccine. 2012 Feb 21;30(9):1729-36. doi: 10.1016/j.vaccine.2011.12.045. Epub 2011 Dec 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | V710 (60 mcg) Lyophilized | V710 (60 mcg) single dose at baseline. |
| FG001 | Placebo | Saline placebo single dose at baseline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V710 (60 mcg) Lyophilized | V710 (60 mcg) single dose at baseline. |
| BG001 | Placebo | Saline placebo single dose at baseline. |
| 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) After the Administration of the Lyophilized Formulation of V710 (60 mcg). | Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac). | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Prevaccination to 14 days postvaccination |
|
All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
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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 (60 mcg) Lyophilized | V710 (60 mcg)single dose at baseline. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye haemorrhage | Eye disorders | MedDRA 11.0 | 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 |
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| Comparator: placebo |
| Biological |
Single dose of buffered saline placebo (0.5 mL) by intramuscular injection. |
|
| Prevaccination to 14 days postvaccination |
| GMFR in Antibody Concentration From Baseline | An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac. | Prevaccination to Days 10, 14, 28, and 84 postvaccination |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Saline placebo single dose at baseline.
|
|
| Other Pre-specified | GMFR by Age | Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Prevaccination to 14 days postvaccination |
|
|
|
| Other Pre-specified | GMFR in Antibody Concentration From Baseline | An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Prevaccination to Days 10, 14, 28, and 84 postvaccination |
|
|
|
| 0 |
| 41 |
| 15 |
| 41 |
| EG001 | Placebo | Saline placebo single dose at baseline. | 0 | 10 | 3 | 10 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Day 28 |
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| Day 84 |
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