Approval Probability
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MF59C.1-adjuvanted subunit influenza vaccine · 1 trial · 4 indications
The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50.
The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MF59C.1-adjuvanted subunit influenza vaccine | BIOLOGICAL | 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm |
| Sub unit, Inactivated, Influenza vaccine | BIOLOGICAL | 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm |
Inclusion Criteria: * Male and female previously unvaccinated healthy children aged 6 to \<36 months. Exclusion Criteria: * Any known or suspected impairment of the immune system, any serious disease. * Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks ...
MF59C.1-adjuvanted subunit influenza vaccine is an investigational vaccine being developed for the prevention of seasonal influenza. It is designed to be given to previously unvaccinated healthy subjects, including children as young as 6 months, to generate immunity against influenza viruses.
MF59C.1-adjuvanted subunit influenza vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in clinical development for seasonal influenza.
MF59C.1-adjuvanted subunit influenza vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the vaccine remains under investigation for seasonal influenza.
MF59C.1-adjuvanted subunit influenza vaccine has been studied in one completed Phase 2 clinical trial, registered as NCT01342796. The trial evaluated humoral and cell-mediated immunity and safety of the vaccine compared with a conventional subunit influenza vaccine in previously unvaccinated healthy subjects in Belgium.
MF59C.1-adjuvanted subunit influenza vaccine is not the same as a conventional subunit influenza vaccine. It contains the MF59C.1 adjuvant, which is intended to enhance the immune response. In clinical trials, it has been compared directly against a conventional subunit influenza vaccine without this adjuvant.