Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Supemtek · 1 trial · 2 indications
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers.
| Arm | Type | Description |
|---|---|---|
| Supemtek® arm | ACTIVE_COMPARATOR | Patients recieving a quadrivalent recombinant high-dose influenza vaccine containing 45 µg of hemagglutinin (HA) for each of the 4 strains included (2 strains A and 2 strains B). Solution for injection is sterile liquid supplied in 0.5mL single dose pre-filled syringe. Vaccine is injected intra-muscularly in the non-dominant arm at Day 0. |
| Vaxigriptetra® arm | ACTIVE_COMPARATOR | Patients receiving a quadrivalent inactivated influenza vaccine containing 15 µg of hemagglutinin (HA) for each of the 4 strains included. Suspension for injection is sterile liquid supplied in 0.5mL single dose pre-filled syringe. Vaccine is injected intra-muscularly in the non-dominant arm at Day 0. |
| Name | Type | Description |
|---|---|---|
| Supemtek® | BIOLOGICAL | Quadrivalent recombinant high-dose influenza vaccine containing 45 µg of hemagglutinin (HA) for each of the 4 strains included (2 strains A and 2 strains B). Solution for injection is sterile liquid supplied in 0.5mL single dose pre-filled syringe. Vaccine is injected intra-muscularly in the non-dominant arm at Day 0. |
| Vaxigriptetra® | BIOLOGICAL | Quadrivalent inactivated influenza vaccine containing 15 µg of hemagglutinin (HA) for each of the 4 strains included. Suspension for injection is sterile liquid supplied in 0.5mL single dose pre-filled syringe. Vaccine is injected intra-muscularly in the non-dominant arm at Day 0. |
Inclusion Criteria: 1. ≥18 and ≤75 years old 2. Body Mass Index (BMI) ≥35 kg/m2 3. No previous vaccination against influenza (in the preceding 6 months) with either the trial vaccine or another vaccine 4. Absence of health event satisfying the definition of a serious adverse event, or a change in a...