Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07128615 | A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA) | PHASE1 | ACTIVE NOT_RECRUITING | 405 | — | — | Sep 4, 2025 | Dec 29, 2026 | Mar 23, 2026 | 14 | United States |
A binary endpoint, defined as ≥ 1:40 HAI titer 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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Arm 5: DL1 of AZD5315 18 to 64 years of age | EXPERIMENTAL | Participants will receive DL1 AZD5315. |
| Arm 6: DL2 of AZD5315 18 to 64 years of age | EXPERIMENTAL | Participants will receive DL2 AZD5315. |
| Arm 7: DL1 of AZD5315 >= 65 years of age | EXPERIMENTAL | Participants will receive DL1 AZD5315. |
| Arm 8: DL2 of AZD5315 >= 65 years of age | EXPERIMENTAL | Participants will receive DL2 AZD5315. |
| Arm 9: placebo 18 to 64 years of age | PLACEBO_COMPARATOR | Participants will receive placebo. |
| Arm 10: placebo >= 65 years of age | PLACEBO_COMPARATOR | Participants will receive placebo. |
| Name | Type | Description |
|---|---|---|
| AZD4117 | BIOLOGICAL | Intramuscular (IM) injection |
| AZD5315 | BIOLOGICAL | IM injection |
| Placebo | OTHER | IM injection |
Key Inclusion Criteria: * Adults, ≥ 18 years of age at the time of signing the informed consent * Participants who are medically stable such that, according to the judgement of the Investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able...