Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lot A 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...
Lot A of Influenza virus vaccine is an investigational vaccine being studied for the prevention of influenza. It is a monoclonal antibody modality, though it is administered as a vaccine. The vaccine is intended for use in healthy adults aged 18 to 49 years.
Lot A of Influenza virus vaccine is being developed by Novartis AG, a multinational pharmaceutical company. Novartis AG is publicly traded under the ticker symbol NVS on the New York Stock Exchange.
Lot A of Influenza virus vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trial has been completed, but the vaccine remains under investigation.
Lot A of Influenza virus vaccine has been studied in one completed Phase 3 clinical trial, identified as NCT00617851. This trial evaluated the consistency of three consecutive production lots of the vaccine in healthy subjects aged 18 to 49 years, with a total enrollment of 1507 participants.
Lot A of Influenza virus vaccine is a specific lot of an influenza vaccine being developed by Novartis AG. The trial NCT00617851 was designed to evaluate the consistency of three consecutive production lots, with Lot A being one of them. It is an investigational vaccine for influenza.