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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
| Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB) | UNKNOWN |
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The purpose of this study is to evaluate the safety and immunogenicity of two investigational vaccines, AZD4117 and AZD5315 to protect against certain strains of avian Influenza A (H5N1 and H7N9 subtypes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of age | Experimental | Participants will receive DL1 AZD4117. |
|
| Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of age | Experimental | Participants will receive DL2 AZD4117. |
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| Arm 3: DL1 of AZD4117 >= 65 years of age | Experimental | Participants will receive DL1 AZD4117. |
|
| Arm 4: DL2 of AZD4117 >= 65 years of age | Experimental | Participants will receive DL2 AZD4117. |
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| Arm 5: DL1 of AZD5315 18 to 64 years of age | Experimental | Participants will receive DL1 AZD5315. |
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| Arm 6: DL2 of AZD5315 18 to 64 years of age | Experimental | Participants will receive DL2 AZD5315. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4117 | Biological | Intramuscular (IM) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with immediate unsolicited adverse events (AE) | Within 30 minutes after dosing | |
| Percentage of participants with injection site and systemic solicited adverse reactions (AR) | Through 7 days after dosing | |
| Percentage of participants with unsolicited AE | Through 28 days after the last dose | |
| Percentage of participants with serious adverse events (SAE) | Through 12 months after the last dose | |
| Percentage of participants with medically attended adverse events (MAAE) | Through 12 months after the last dose | |
| Percentage of participants with adverse events of special interest (AESI) | Through 12 months after the last dose | |
| Proportion of participants achieving ≥ 1:40 HAI titer post-IMP administration | A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration. | Day 58 |
| Proportion of participants achieving seroconversion post-IMP administration | Seroconversion status, defined as either a pre-IMP administration HAI titer < 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer. | Day 58 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) of HAI antibody | Days 1 to 389 | |
| Geometric mean fold-rise (GMFR) of HAI antibody titers from baseline | The fold rise is calculated as the ratio of the post-dose titer to the pre-dose titer. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Long Beach | California | 90815 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Masking will be secured to the syringe after preparation by unblinded personnel
|
| Arm 7: DL1 of AZD5315 >= 65 years of age | Experimental | Participants will receive DL1 AZD5315. |
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| Arm 8: DL2 of AZD5315 >= 65 years of age | Experimental | Participants will receive DL2 AZD5315. |
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| Arm 9: placebo 18 to 64 years of age | Placebo Comparator | Participants will receive placebo. |
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| Arm 10: placebo >= 65 years of age | Placebo Comparator | Participants will receive placebo. |
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| AZD5315 | Biological | IM injection |
|
| Placebo | Other | IM injection |
|
| Days 29 to 389 |
| Proportion of participants achieving a ≥1:40 HAI titer post-IMP administration | A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration. | Days 29 to 389 |
| Proportion of participants achieving seroconversion post-IMP administration | Seroconversion status, defined as either a pre-IMP administration HAI titer < 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer. | Days 29 to 389 |
| Rolling Hills Estates |
| California |
| 90274 |
| United States |
| Research Site | Hialeah | Florida | 33012 | United States |
| Research Site | Stockbridge | Georgia | 30281 | United States |
| Research Site | Chicago | Illinois | 60640 | United States |
| Research Site | Lenexa | Kansas | 66219 | United States |
| Research Site | Kansas City | Missouri | 64114 | United States |
| Research Site | Omaha | Nebraska | 68134 | United States |
| Research Site | Las Vegas | Nevada | 89119 | United States |
| Research Site | Cincinnati | Ohio | 45212 | United States |
| Research Site | Edmond | Oklahoma | 73013 | United States |
| Research Site | North Charleston | South Carolina | 29405 | United States |
| Research Site | Austin | Texas | 78745 | United States |
| Research Site | West Jordan | Utah | 84088 | United States |