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Pandemic flu H5 HA mRNA SD2 vaccine · 1 trial · 2 indications
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| 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...
The Pandemic flu H5 HA mRNA SD2 vaccine is an investigational mRNA vaccine developed by Sanofi for pandemic influenza immunization. It is designed to protect against the H5 hemagglutinin strain of influenza. It is currently in Phase 1 clinical development and has not been approved by any regulatory agency.
The Pandemic flu H5 HA mRNA SD2 vaccine is being developed for pandemic influenza immunization. It aims to prevent illness caused by the H5 HA strain of influenza virus. The vaccine is intended for healthy adults aged 18 years and older.
Sanofi is developing the Pandemic flu H5 HA mRNA SD2 vaccine. Sanofi is a global biopharmaceutical company traded on the Nasdaq under the ticker symbol SNY. The vaccine is part of Sanofi's pandemic influenza preparedness efforts.
The Pandemic flu H5 HA mRNA SD2 vaccine is in Phase 1 clinical development. A single Phase 1 trial is currently active and recruiting participants. The vaccine is investigational and has not been approved for any indication.
The Pandemic flu H5 HA mRNA SD2 vaccine is being evaluated in one clinical trial: NCT06907511. This Phase 1 study is titled "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." It is active but not recruiting, with an estimated enrollment of 720 participants in the United States.
No, the Pandemic flu H5 HA mRNA SD2 vaccine is not approved by the FDA. It is an investigational vaccine currently in Phase 1 clinical testing. Approval status has not been granted for any indication.