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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...
Influenza A Vaccine: ACAM FLU-A is an investigational vaccine being developed for the prevention of influenza, a contagious respiratory illness caused by influenza viruses. It is designed to be administered to healthy adults to potentially provide immunity against influenza A infections.
Influenza A Vaccine: ACAM FLU-A is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research to evaluate the safety and immunogenicity of this investigational vaccine.
Influenza A Vaccine: ACAM FLU-A is currently in Phase 1 of clinical development. It is an investigational vaccine that has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under investigation for its safety and potential efficacy.
Influenza A Vaccine: ACAM FLU-A has been studied in one completed Phase 1 clinical trial, identified as NCT00819013. This trial was titled 'Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults' and enrolled 87 participants in the United States. The study was randomized, double-blind, and placebo-controlled.
Yes, Influenza A Vaccine: ACAM FLU-A is also known as ACAM FLU-A. The vaccine is referred to by both names in clinical research and development contexts. It is an investigational vaccine being developed by Sanofi for the prevention of influenza.