Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lot B of Influenza virus vaccine · 1 trial · 1 indication
The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.
| Arm | Type | Description |
|---|---|---|
| Influenza virus vaccine (lot A) | EXPERIMENTAL | Lot A of the investigational influenza virus vaccine |
| Influenza virus vaccine (lot B) | EXPERIMENTAL | Lot B of the investigational influenza virus vaccine |
| Influenza virus vaccine (lot C) | EXPERIMENTAL | Lot C of the investigational influenza virus vaccine |
| Influenza virus vaccine (pooled) | EXPERIMENTAL | Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine |
| Comparator influenza vaccine | ACTIVE_COMPARATOR | A US licensed influenza virus vaccine |
| Name | Type | Description |
|---|---|---|
| Lot A of Influenza virus vaccine | BIOLOGICAL | 1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly |
| Lot B of Influenza virus vaccine | BIOLOGICAL | 1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly |
| Lot C of Influenza virus vaccine | BIOLOGICAL | 1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly |
| Comparator influenza virus vaccine | BIOLOGICAL | 1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly |
| All 3 consecutive lots of influenza virus vaccine pooled | BIOLOGICAL | 1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly |
Inclusion Criteria: * 18 to 49 years of age; * In good health as determined by medical history and physical examination; * Able and willing to provide written informed consent prior to any study procedure; * Able to comply with all study procedures and available for all clinic visits scheduled in t...