Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
adjuvanted A influenza vaccine · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Group A: High Risk Population | EXPERIMENTAL | Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22 |
| Group B: High Risk Subjects | EXPERIMENTAL | Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22 |
| Group C: Healthy Subjects | EXPERIMENTAL | Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22 |
| Group D: Healthy Subjects | EXPERIMENTAL | Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22 |
| Name | Type | Description |
|---|---|---|
| adjuvanted A(H1N1) influenza vaccine | BIOLOGICAL | 7.5 ug of HA antigen; adjuvanted; monovalent |
| non-adjuvanted A(H1N1) influenza vaccine | BIOLOGICAL | 15ug of HA antigen, non-adjuvanted; trivalent |
Inclusion Criteria: For Invasive Solid Tumor Subjects: * Subjects between 2 and 70 years of age (inclusive) * Any sex or ethnicity * Confirmed diagnosis of Invasive Solid Tumor or hematological malignancies in complete remission for at least 3 months and not more than 18 months after the last neo-...
Adjuvanted A influenza vaccine is used for H1N1 influenza virus. It is being studied in patients with invasive solid tumors to compare its immunogenicity, safety, and tolerability against non-adjuvanted H1N1 influenza vaccines. The vaccine is designed to elicit an immune response against the H1N1 strain.
Adjuvanted A influenza vaccine is being developed by Fortrea Holdings Inc. Common Stock, which trades under the ticker FTRE. The company is conducting clinical research on this vaccine for H1N1 influenza virus.
Adjuvanted A influenza vaccine is in Phase 3 clinical development. It is an investigational vaccine, not yet approved, and is being evaluated for its immunogenicity, safety, and tolerability in patients with invasive solid tumors.
Adjuvanted A influenza vaccine has one completed Phase 3 trial, NCT01031719, which enrolled 59 participants in Brazil. The trial compared the adjuvanted vaccine to non-adjuvanted H1N1 influenza vaccines in patients with invasive solid tumors, with healthy volunteers also included.
Adjuvanted A influenza vaccine works by incorporating an adjuvant to enhance the immune response to the H1N1 influenza virus antigen. This approach aims to improve immunogenicity compared to non-adjuvanted vaccines, particularly in immunocompromised patients such as those with solid tumors.