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The study is being conducted to explore the safety and tolerability of CoVaccine HT in healthy male and female volunteers. In this study volunteers will receive intramuscular injections of CoVaccine HT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoVaccine HT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoVaccine HT | Biological | intramuscular injection, dose escalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Events | Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event. | Duration of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Wilbraham, MB., BS | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Drug Research Unit | London | SE1 1YR | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 mg Dose | 1 mg CoVaccine HT |
| FG001 | 2 mg Dose | 2 mg CoVaccine HT |
| FG002 | 5 mg Dose | 5 mg CoVaccine HT |
| FG003 | 7 mg Dose | 7 mg CoVaccine HT |
| FG004 | 10 mg Dose | 10 mg CoVaccine HT |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population, subjects who received at least one dose of test article
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 mg Dose | 1 mg CoVaccine HT |
| BG001 | 2 mg Dose | 2 mg CoVaccine HT |
| BG002 |
| 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 | Safety Events | Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event. | Posted | Number | percentage of patients | Duration of 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 | 1 mg Dose | 1 mg CoVaccine HT |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| influenza-like illness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SVP Clinical Development | BTG International Inc. | 610-278-1660 | angela.ogden@btgplc.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Adverse Event |
|
| Protocol Violation |
|
| 5 mg Dose |
5 mg CoVaccine HT |
| BG003 | 7 mg Dose | 7 mg CoVaccine HT |
| BG004 | 10 mg Dose | 10 mg CoVaccine HT |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG003 | 7 mg Dose | 7 mg CoVaccine HT |
| OG004 | 10 mg Dose | 10 mg CoVaccine HT |
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | 2 mg Dose | 2 mg CoVaccine HT | 0 | 10 | 0 | 10 |
| EG002 | 5 mg Dose | 5 mg CoVaccine HT | 0 | 10 | 4 | 10 |
| EG003 | 7 mg Dose | 7 mg CoVaccine HT | 0 | 10 | 5 | 10 |
| EG004 | 10 mg Dose | 10 mg CoVaccine HT | 0 | 10 | 4 | 10 |
| injection site pain | General disorders | Systematic Assessment |
|
| malaise | General disorders | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
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