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| ID | Type | Description | Link |
|---|---|---|---|
| HHSO100200700031C |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 30 µg HA, no LT patch | Experimental | A/H5N1 Vaccine 30 µg HA i.m. on Day 0 |
|
| Group 2: 30 µg HA + 50 µg LT patch | Experimental | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 |
|
| Group 3: 30 µg HA + 100 µg LT patch | Experimental | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 |
|
| Group 4: 45 µg HA, no LT patch | Experimental | A/H5N1 Vaccine 45 µg HA i.m. on Day 0 |
|
| Group 5: 45 µg HA + 50 µg LT patch | Experimental | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 |
|
| Group 6: 45 µg HA + 100 µg LT patch |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A/H5N1 | Biological | A/H5N1 Low Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28. | Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch | 6 months | |
| Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sheldon, MD | Miami Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| Solano Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 30 µg HA, no LT Patch | A/H5N1 Vaccine 30 µg HA i.m. on Day 0 A/H5N1: A/H5N1 Low Dose |
| FG001 | Group 2: 30 µg HA + 50 µg LT Patch | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 A/H5N1: A/H5N1 Low Dose LT Adjuvant Patch: LT Adjuvant Patch Low Dose |
| FG002 | Group 3: 30 µg HA + 100 µg LT Patch | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 A/H5N1: A/H5N1 Low Dose LT Adjuvant Patch: LT Adjuvant Patch High Dose |
| FG003 | Group 4: 45 µg HA, no LT Patch | A/H5N1 Vaccine 45 µg HA i.m. on Day 0 A/H5N1: A/H5N1 High Dose |
| FG004 | Group 5: 45 µg HA + 50 µg LT Patch | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 A/H5N1: A/H5N1 High Dose LT Adjuvant Patch: LT Adjuvant Patch Low Dose |
| FG005 | Group 6: 45 µg HA + 100 µg LT Patch | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 A/H5N1: A/H5N1 High Dose LT Adjuvant Patch: LT Adjuvant Patch High Dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
safety population: all subjects with signed Informed Consent who have received investigational product
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 30 µg HA, no LT Patch | A/H5N1 Vaccine 30 µg HA i.m. on Day 0 A/H5N1: A/H5N1 Low Dose |
| BG001 | Group 2: 30 µg HA + 50 µg LT Patch | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 A/H5N1: A/H5N1 Low Dose LT Adjuvant Patch: LT Adjuvant Patch Low Dose |
| 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 | Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28. | Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%. | Primary Immunogenicity Evaluable Population (PIEP): all subjects who were consented, randomized, received the assigned treatment, had HI assay results at all the following time points: baseline (Day 0), Day 21 and Day 28, and did not have any major protocol deviations | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 28 |
|
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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 | Group 1: 30 µg HA, no LT Patch | A/H5N1 Vaccine 30 µg HA i.m. on Day 0 A/H5N1: A/H5N1 Low Dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head Clinical Development | Valneva Austria GmbH | 0043120620 | 0 | info@valneva.com |
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| Experimental |
A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 |
|
| A/H5N1 | Biological | A/H5N1 High Dose |
|
| LT Adjuvant Patch | Biological | LT Adjuvant Patch Low Dose |
|
| LT Adjuvant Patch | Biological | LT Adjuvant Patch High Dose |
|
| Day 28 |
| Vallejo |
| California |
| 94589 |
| United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| Accelovance | South Bend | Indiana | 46601 | United States |
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| BG002 | Group 3: 30 µg HA + 100 µg LT Patch | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 A/H5N1: A/H5N1 Low Dose LT Adjuvant Patch: LT Adjuvant Patch High Dose |
| BG003 | Group 4: 45 µg HA, no LT Patch | A/H5N1 Vaccine 45 µg HA i.m. on Day 0 A/H5N1: A/H5N1 High Dose |
| BG004 | Group 5: 45 µg HA + 50 µg LT Patch | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 A/H5N1: A/H5N1 High Dose LT Adjuvant Patch: LT Adjuvant Patch Low Dose |
| BG005 | Group 6: 45 µg HA + 100 µg LT Patch | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 A/H5N1: A/H5N1 High Dose LT Adjuvant Patch: LT Adjuvant Patch High Dose |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
A/H5N1 Vaccine 30 µg HA i.m. on Day 0
A/H5N1: A/H5N1 Low Dose
| OG001 | Group 2: 30 µg HA + 50 µg LT Patch | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 A/H5N1: A/H5N1 Low Dose LT Adjuvant Patch: LT Adjuvant Patch Low Dose |
| OG002 | Group 3: 30 µg HA + 100 µg LT Patch | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 A/H5N1: A/H5N1 Low Dose LT Adjuvant Patch: LT Adjuvant Patch High Dose |
| OG003 | Group 4: 45 µg HA, no LT Patch | A/H5N1 Vaccine 45 µg HA i.m. on Day 0 A/H5N1: A/H5N1 High Dose |
| OG004 | Group 5: 45 µg HA + 50 µg LT Patch | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 A/H5N1: A/H5N1 High Dose LT Adjuvant Patch: LT Adjuvant Patch Low Dose |
| OG005 | Group 6: 45 µg HA + 100 µg LT Patch | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 A/H5N1: A/H5N1 High Dose LT Adjuvant Patch: LT Adjuvant Patch High Dose |
|
|
| Secondary | Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch | Posted | Number | Number of Events | 6 months |
|
|
|
| Secondary | Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity | Posted | Geometric Mean | 95% Confidence Interval | fold increase of Geometric Mean Titers | Day 28 |
|
|
|
| 0 |
| 50 |
| 31 |
| 50 |
| EG001 | Group 2: 30 µg HA + 50 µg LT Patch | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 A/H5N1: A/H5N1 Low Dose LT Adjuvant Patch: LT Adjuvant Patch Low Dose | 0 | 100 | 86 | 100 |
| EG002 | Group 3: 30 µg HA + 100 µg LT Patch | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 A/H5N1: A/H5N1 Low Dose LT Adjuvant Patch: LT Adjuvant Patch High Dose | 1 | 102 | 86 | 102 |
| EG003 | Group 4: 45 µg HA, no LT Patch | A/H5N1 Vaccine 45 µg HA i.m. on Day 0 A/H5N1: A/H5N1 High Dose | 0 | 50 | 36 | 50 |
| EG004 | Group 5: 45 µg HA + 50 µg LT Patch | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 A/H5N1: A/H5N1 High Dose LT Adjuvant Patch: LT Adjuvant Patch Low Dose | 1 | 98 | 87 | 98 |
| EG005 | Group 6: 45 µg HA + 100 µg LT Patch | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 A/H5N1: A/H5N1 High Dose LT Adjuvant Patch: LT Adjuvant Patch High Dose | 1 | 100 | 85 | 100 |
| Adenomyosis | Reproductive system and breast disorders |
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| Hypotension | Vascular disorders |
|
| Malaise | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vaccination site erythema | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vaccination site rash | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vaccination site hyperpigmentation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vaccination site edema | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vaccination site pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vaccination site induration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vaccination site eccymosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vaccination site pruritis | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| Local AEs |
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| Systemic AEs |
|
| All Severe AEs |
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| Severe Local AEs |
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| Related Severe Local AEs |
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| Severe Systemic AEs |
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| Related Severe Systemic AEs |
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| All Serious AEs |
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| Serious Local AEs |
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| Serious Systemic AEs |
|