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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06907511 | Study to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older | PHASE1 | ACTIVE NOT_RECRUITING | 720 | — | — | Apr 17, 2025 | Dec 1, 2026 | Jan 16, 2026 | 13 | United States |
Number of participants with immediate AEs
Number of participants with solicited injection site reactions
Number of participants with solicited systemic reactions
Number of participants with unsolicited AEs
Number of participants with MAAEs
Number of participants with AESIs
Number of participants with SAEs
Number of participants with out-of-range biological test results
| Arm | Type | Description |
|---|---|---|
| Group 1: Pandemic flu H5 HA mRNA SD2 vaccine (Low dose) | EXPERIMENTAL | Participants will receive two injections of low dose pandemic flu H5 HA mRNA SD2 vaccine Extension Phase: Additional participants will receive two injections 21 days apart of pandemic flu H5 HA mRNA SD2 vaccine at low dose |
| Group 2: Pandemic flu H5 HA mRNA SD2 vaccine (Medium dose) | EXPERIMENTAL | Participants will receive two injections of medium dose pandemic flu H5 HA mRNA SD2 vaccine |
| Group 3: Pandemic flu H5 HA mRNA SD2 vaccine (High dose) | EXPERIMENTAL | Participants will receive two injections of high dose pandemic flu H5 HA mRNA SD2 vaccine |
| Group 4: Placebo | PLACEBO_COMPARATOR | Participants will receive two injections of placebo Extension Phase: Additional participants will receive two injections 21 days apart of placebo |
| Name | Type | Description |
|---|---|---|
| Pandemic flu H5 HA mRNA SD2 vaccine | BIOLOGICAL | Pharmaceutical Form: Suspension in a vial Route of Administration: Intramuscular injection |
| Placebo | OTHER | Pharmaceutical Form: Liquid solution in a vial Route of Administration: Intramuscular injection |
Inclusion Criteria: * Aged 18 years or older on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female...