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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05163847 | Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults | PHASE1 | COMPLETED | 303 | — | — | Jun 14, 2022 | Nov 3, 2022 | Nov 14, 2022 | 6 | United States |
The number and percentage of subjects who experience solicited local and systemic reactions during the 7 days after vaccine administration of M2SR administration alone or with IIV
The number and percentage of subjects who experience unsolicited AEs during the 28 days after vaccine administration of M2SR alone or with IIV.
The number and percentage of subjects who experience SAEs from the time of informed consent through 28 days after vaccine administration of M2SR alone or with IIV.
| Arm | Type | Description |
|---|---|---|
| M2SR only dose | EXPERIMENTAL | Intranasal M2SR vaccine and intramuscular placebo dose |
| M2SR with IIV dose | EXPERIMENTAL | Intranasal M2SR vaccine and intramuscular IIV dose |
| IIV only dose | ACTIVE_COMPARATOR | Intranasal placebo dose and intramuscular IIV dose |
| Placebo only dose | PLACEBO_COMPARATOR | Intranasal placebo dose and intramuscular placebo dose |
| Name | Type | Description |
|---|---|---|
| Cam2020 M2SR H3N2 influenza vaccine | BIOLOGICAL | Administered intranasally on Day 1 |
| Fluzone HD IIV | BIOLOGICAL | Administered intramuscularly on Day 1 |
| IN Placebo | OTHER | Administered intranasally on Day 1 |
| IM Placebo | OTHER | Administered intramuscularly on Day 1 |
Inclusion Criteria: 1. Subjects must be willing and able to provide written informed consent to participate; a legally authorized representative (LAR) may not be used. 2. Males and nonchildbearing potential females 65-85 years of age at the time of consent. 3. Subjects must be willing to adhere to ...