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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAX102 IM | Experimental | VAX102 given as 1 µg intramuscular (i.m.) |
|
| VAX102 SC | Experimental | VAX102 given as a 2 µg subcutaneous (s.c.) dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAX102 | Biological | Universal M2e influenza vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Solicited local and general symptoms experienced within 7 days after vaccination 1. | 0 to 7 days after vaccination |
| Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Solicited local and general symptoms experienced within 14 days after vaccination 2 | 14 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-M2e Serum Antibody Concentration | Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population. | 42 days (+/- 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David N Taylor, MD | VaxInnate Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | VAX102 IM | Given as 1 µg intramuscular |
| FG001 | VAX102 SC | Given as 2 µg subcutaneous |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Day 0 |
|
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| COMPLETED |
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| NOT COMPLETED |
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| Day 28 |
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| ID | Title | Description |
|---|---|---|
| BG000 | VAX102 IM | Given as 1 µg intramuscular |
| BG001 | VAX102 SC | Given as 2 µg subcutaneous |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Solicited local and general symptoms experienced within 7 days after vaccination 1. | The population analyzed included all participants receiving at least 1 dose of the vaccine. | Posted | Number | participants | 0 to 7 days after vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Anti-M2e Serum Antibody Concentration | Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 42 days (+/- 2) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Solicited local and general symptoms experienced within 14 days after vaccination 2 | Posted | Number | participants | 14 days after vaccination |
|
|
Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 42 days following vaccination.
All reactogenicity findings were recorded in the CRFs. Symptoms from the Reactogenicity Memory Aid were reported as "reactogenicity", and presumed to be related to the investigational product. These complaints were not additionally recorded as AEs.
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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 | VAX102 IM | Given as 1 µg intramuscular | 1 | 28 | 0 | 28 | ||
| EG001 | VAX102 SC | Given as 2 µg subcutaneous | 0 | 30 | 0 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydronephrosis | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David N.Taylor | VaxInnate | 609-860-2260 | david.taylor@vaxinnate.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C559063 | VAX102 vaccine |
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| Male |
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| Bruising |
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| Arm Pain |
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| Headache |
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| Fatigue |
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| Joint Pain |
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| Muscle Aches |
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| Chills |
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| Sweating |
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