Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TIVc_LOT A · 1 trial · 1 indication
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
| Arm | Type | Description |
|---|---|---|
| TIVc-Lot A | EXPERIMENTAL | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A |
| TIVc-Lot B | EXPERIMENTAL | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B |
| TIVc-Lot C | EXPERIMENTAL | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C |
| TIVf | ACTIVE_COMPARATOR | Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf |
| Name | Type | Description |
|---|---|---|
| TIVc_LOT A | BIOLOGICAL | Single IM (Intramuscular) administration dose of 0.5 mL of TIVc |
| TIVc_LOT B | BIOLOGICAL | Single IM administration dose of 0.5 mL of TIVc |
| TIVc_LOT C | BIOLOGICAL | Single IM administration dose of 0.5 mL of TIVc |
| TIVf | BIOLOGICAL | Single IM administration dose of 0.5 mL of TIVf |
Inclusion Criteria: * Males or females 18 through 49 years of age. * Subjects having provided informed consent. * Individuals in good health Exclusion Criteria: * Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, i...
TIVc_LOT A is an investigational monoclonal antibody being developed for the prophylaxis of influenza. It is intended to prevent influenza infection in healthy adults. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
TIVc_LOT A is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational monoclonal antibody for influenza prophylaxis.
TIVc_LOT A is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The Phase 3 trial has been completed, and the drug is being evaluated for its safety and immunogenicity in preventing influenza.
TIVc_LOT A has been studied in one completed Phase 3 clinical trial with the identifier NCT02256488. This trial, titled 'Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects,' enrolled 1,561 healthy adult participants in the United States and was randomized, double-blind, and active-controlled.
TIVc_LOT A is a monoclonal antibody designed to provide prophylaxis against influenza. As a monoclonal antibody, it is intended to target and neutralize influenza viruses, thereby preventing infection. The drug is being evaluated for its ability to elicit a protective immune response in healthy adults.