Approval Probability
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Influenza vaccine · 1 trial · 1 indication
Difference in seroconversion rates in both treatment groups at 5, 10, 15 weeks, and 12 months after the first vaccine dose (percent of patients with 4 x increase in the pre-vaccination titers).
| Arm | Type | Description |
|---|---|---|
| Influenza vaccine, second administration after 5 weeks | EXPERIMENTAL | Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first one. |
| Influenza vaccine | ACTIVE_COMPARATOR | Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. |
| Name | Type | Description |
|---|---|---|
| Influenza vaccine | BIOLOGICAL | Patients will be randomized at 1:1 rate and open label fashion, according to centers, and time elapsed since transplant and type of organ transplanted to one of this two interventions : A arm (usual treatment): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. B arm (experimental branch): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first dose. The follow-up of both arms will be at 5, 10 and 15 weeks and one year after the baseline. |
Inclusion Criteria: 1. Solid organ transplant recipient. 2. 16 years or older. 3. More than 30 days after transplantation. 4. Negative pregnancy test for women of childbearing potential 5. The patient must give informed consent Exclusion Criteria: 1. No written informed consent. 2. Acute rejectio...
Influenza vaccine is used to prevent influenza infection in solid organ transplant recipients. It is being studied as a single dose versus two doses to evaluate efficacy and safety in this patient population. The vaccine is administered to individuals aged 16 years and older.
Influenza vaccine is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker DSGN. The company is conducting clinical research to evaluate the vaccine's use in solid organ transplant recipients.
Influenza vaccine is in Phase 3 clinical development. It is an investigational product and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine is being evaluated for its efficacy and safety in solid organ transplant recipients.
Influenza vaccine has one completed Phase 3 clinical trial registered as NCT01761435. This trial evaluated the efficacy and safety of one dose versus two doses of influenza vaccination in 499 solid organ transplant recipients in Spain. The study was active-controlled and included participants aged 16 years and older.
Yes, Influenza vaccine is classified as a monoclonal antibody modality. It is being developed for the prevention of influenza infection in solid organ transplant recipients. The Phase 3 trial has been completed, and the vaccine remains investigational.
Influenza vaccine works by stimulating the immune system to produce antibodies against influenza viruses. As a monoclonal antibody, it may also directly neutralize the virus. The vaccine is being studied to determine the optimal dosing regimen, comparing one dose versus two doses, in solid organ transplant recipients.