Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cam2020 M2SR H3N2 influenza vaccine · 1 trial · 1 indication
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 ...
Cam2020 M2SR H3N2 influenza vaccine is an investigational vaccine being developed for the prevention of influenza. It is designed to be used as a monovalent vaccine, either alone or in combination with a licensed inactivated influenza vaccine (IIV), to generate an immune response against the H3N2 influenza strain.
Cam2020 M2SR H3N2 influenza vaccine is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity.
Cam2020 M2SR H3N2 influenza vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to assess its safety and immunogenicity in older adults.
Cam2020 M2SR H3N2 influenza vaccine has been studied in one completed Phase 1 clinical trial, registered as NCT05163847. The trial, titled 'Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults,' enrolled 303 participants aged 65 years and older in the United States.
Cam2020 M2SR H3N2 influenza vaccine is a specific formulation of the M2SR vaccine platform, targeting the H3N2 influenza strain. It is being evaluated as a monovalent vaccine, either alone or with a licensed inactivated influenza vaccine, to enhance immune responses in older adults.