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The objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over one month. The study will last approximately 10 months and will have a total of 7 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1 | Active Comparator |
| |
| T2 | Active Comparator |
| |
| C1 | Placebo Comparator |
| |
| C2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVX502 | Biological | 2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of AVX502 in healthy adult volunteers 65 years of age or older via the frequency of systemic reactogenicity events, local vaccine reactions and Adverse Events | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the immunogenicity of AVX502 in healthy adult volunteers 65 years of age and older via serum antibody concentration | 4 weeks after second dose of vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Olmsted, Ph.D. | AlphaVax, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
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| Label | URL |
|---|---|
| AlphaVax, Inc. | View source |
| Johnson County Clin-Trials | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| AVX502 |
| Biological |
2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route |
|
| Placebo | Biological | 2 doses of placebo given at T=0 and T=4 weeks via the IM route |
|
| Placebo | Biological | 2 doses of placebo given at T=0 and T=4 weeks via the SC route |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |