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Influenza A Vaccine: ACAM FLU-A · 1 trial · 1 indication
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | ACAM-FLU-A low dose + Adjuvant 1 |
| Study Group 2 | EXPERIMENTAL | ACAM-FLU-A low dose + Adjuvant 2 |
| Study Group 3 | EXPERIMENTAL | ACAM-FLU-A low dose |
| Study Group 4 | PLACEBO_COMPARATOR | Saline placebo |
| Name | Type | Description |
|---|---|---|
| Influenza A Vaccine: ACAM FLU-A | BIOLOGICAL | 0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular |
| Saline placebo | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Adult males or females 18 - 40 years of age in good general health Exclusion Criteria: * Known allergies or severe reactions to any of the vaccine components including those to adjuvants * History of severe allergic reactions, including angioedema; * History of asthma or rec...
Top 6 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 1 | PHASE3 | mRNA-1018-H5 |
| 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 |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Flu/COVID-19 mRNA combination vaccine |
ACAM FLU-A is an investigational vaccine developed by Sanofi for protection against influenza A. It is a recombinant M2e influenza-A vaccine that was studied in healthy adults. The vaccine remains in Phase 1 clinical development and is not an approved product.
ACAM FLU-A is being developed for the prevention of influenza, specifically influenza A. Its only recorded clinical study enrolled healthy adult volunteers rather than patients with active infection. The vaccine is investigational and has not been approved for use.
ACAM FLU-A is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the Phase 1 study of the vaccine. No other developer or partnership is associated with this asset.
ACAM FLU-A is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA or any other regulator.
ACAM FLU-A has been studied in one completed Phase 1 trial, NCT00819013, titled Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults. The trial enrolled 87 healthy volunteers aged 18 years and older in the United States and used a randomized, double-blind, placebo-controlled design.
Yes. ACAM FLU-A is a recombinant M2e influenza-A vaccine, meaning it is designed around the M2e protein of influenza A rather than a conventional whole-virus or split-virus formulation. It is administered as a vaccine and was tested in healthy adult volunteers in its Phase 1 study.