Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Influenza virus vaccine - cell based (2007-2008 Formulation)
Influenza virus vaccine- cell based · 1 trial · 3 indications
Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
| Arm | Type | Description |
|---|---|---|
| Group 1: Standard-dose Cell-based Influenza Vaccine | EXPERIMENTAL | Participants will receive a single dose of standard-dose cell-based influenza virus vaccine. |
| Group 2: High-dose Cell-based Influenza Vaccine | EXPERIMENTAL | Participants will receive a single dose of high-dose cell-based influenza virus vaccine. |
| Group 3: Licensed Fluzone® Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive a single dose of licensed Fluzone® influenza vaccine. |
| Name | Type | Description |
|---|---|---|
| Influenza virus vaccine - cell based (2007-2008 Formulation) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Influenza virus vaccine - cell-based (2007-2008 Formulation) | BIOLOGICAL | 1.0 mL, Intramuscular |
| Influenza virus vaccine (2007-2008 Formulation) | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria : * Healthy male or female subject, aged ≥ 18 to \< 50 years on the day of inclusion * Informed consent form signed * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential: a negative urine pregnancy test and documente...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
Influenza virus vaccine- cell based is a vaccine developed for the prevention of influenza, a contagious respiratory illness caused by influenza viruses. It is intended for use in healthy adults. The vaccine is designed to stimulate an immune response against influenza virus strains.
Influenza virus vaccine- cell based is being developed by Sanofi, a global pharmaceutical company. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY.
Influenza virus vaccine- cell based is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 2 trial has been completed.
Influenza virus vaccine- cell based has been studied in one completed Phase 2 clinical trial, NCT00845429, titled "Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects." The trial enrolled 729 healthy adult participants in the United States.
Yes, Influenza virus vaccine- cell based is also known as Influenza virus vaccine - cell based (2007-2008 Formulation). The alternative name refers to the specific formulation used in the 2007-2008 influenza season.