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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
| |
| Group D | Experimental |
| |
| Group E | Experimental |
| |
| Group F | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monovalent Avian Influenza VLP (H5N1) | Biological | Dose A without Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of solicited and unsolicited adverse events in H5N1 VLP antigen dose groups delivering HA with/without Adjuvant 1. | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of HAI antibody seroconversion rates and GMT achieved by a constant H5N1 VLP antigen dose alone and in combination with Adjuvant 1. | Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nigel Thomas, Ph.D | Novavax | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States | ||
| Miami Research Associates |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Monovalent Avian Influenza VLP (H5N1) | Biological | Dose B without Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21 |
|
| Monovalent Avian Influenza VLP (H5N1); Adjuvant | Biological | Dose B with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21 |
|
| Monovalent Avian Influenza VLP (H5N1); Adjuvant | Biological | Dose C with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21 |
|
| Monovalent Avian Influenza VLP (H5N1); Adjuvant | Biological | Dose D with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21 |
|
| Saline placebo | Biological | Placebo; Intramuscular, deltoid, Day 0 & Day 21 |
|
| Miami |
| Florida |
| 33143 |
| United States |
| Broward Research Group | Pembroke Pines | Florida | 33026 | United States |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| 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 |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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