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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07300085 | A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine | PHASE1 | ACTIVE NOT_RECRUITING | 100 | — | — | Nov 8, 2025 | Dec 1, 2026 | Mar 24, 2026 | 2 | United States |
Evaluation of immune responses at 2- and 4-weeks post intervention measured by hemagglutinin inhibition (HAI) titers (geometric mean titers \[GMTs\] and seroconversion rates) against the influenza strains contained in the vaccine among participants receiving concomitant Fluzone HD influenza vaccine and CD388 compared to participants who receive Fluzone HD and placebo for CD388.
| Arm | Type | Description |
|---|---|---|
| Fluzone HD plus CD388 | EXPERIMENTAL | Participants will be randomized to receive open-label Fluzone HD influenza vaccine by intramuscular (IM) injection plus CD388 450 milligrams (mg) by subcutaneous (SQ) injection. Participants will be randomized at a 1:1 ratio between the 2 arms. |
| Fluzone HD plus Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive open-label Fluzone HD influenza vaccine by IM injection plus placebo by SQ injection. Participants will be randomized at a 1:1 ratio between the 2 arms. |
| Name | Type | Description |
|---|---|---|
| Fluzone HD influenza vaccine | BIOLOGICAL | Fluzone HD injectable suspension, 2025-2026 Formula |
| CD388 Injection | COMBINATION_PRODUCT | CD388 liquid for injection |
| Placebo | COMBINATION_PRODUCT | Placebo to match |
Inclusion Criteria: 1. Be ≥ 18 to ≤ 49 years of age at the time of signing the informed consent. 2. Be able to understand and comply with the trial procedures, understand the risks involved in the trial, and provide written informed consent before the first trial-specific procedure. 3. Be deemed he...