Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD4117 · 1 trial · 1 indication
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...