Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aflunov · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Vaccine arm 1 | ACTIVE_COMPARATOR | Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks |
| Vaccine arm 2 | ACTIVE_COMPARATOR | Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks |
| Vaccine arm 3 | ACTIVE_COMPARATOR | Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks |
| Vaccine arm 4 | ACTIVE_COMPARATOR | Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks |
| Vaccine arm 5 | ACTIVE_COMPARATOR | Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks |
| vaccine arm 6 | ACTIVE_COMPARATOR | Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks |
| Vaccine arm 7 | ACTIVE_COMPARATOR | Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks |
| Vaccine arm 8 | ACTIVE_COMPARATOR | Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks |
| Vaccine arm 9 | ACTIVE_COMPARATOR | No priming dose and single dose MF59 adjuvanted H5N1 vaccine at 52 weeks |
| Name | Type | Description |
|---|---|---|
| Aflunov (Single prime, single boost) | BIOLOGICAL | Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks |
| Aflunov (Double prime, single boost) | BIOLOGICAL | Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks |
| Aflunov (No prime, single boost) | BIOLOGICAL | No Priming then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks |
Inclusion Criteria: 1. Subjects 18 to 59 years of age, or 60 years of age and older, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol; 2. Are in good health or have one or more stable (See footnote) medical conditions, a...
Aflunov is an investigational monoclonal antibody being developed for influenza, an infectious disease. It is currently in Phase 1 clinical development, meaning it is still being studied and is not yet approved for use. The drug is being evaluated for its potential to address influenza.
Aflunov is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety and efficacy of Aflunov for the treatment or prevention of influenza.
Aflunov is currently in Phase 1 clinical development. This is the earliest stage of testing in humans, primarily focused on assessing the drug's safety, tolerability, and basic pharmacokinetics. As an investigational drug, Aflunov has not yet been approved by regulatory authorities and is not available for clinical use.
Aflunov has been studied in one completed clinical trial, identified by the National Clinical Trial number NCT00814385. This Phase 1 trial, titled 'Immunogenicity of Adjuvanted or Non-adjuvanted H5N1 Booster Vaccine in Adults Primed to A/VN/1194/04', enrolled 606 participants in the United Kingdom. The trial was randomized, double-blind, and active-controlled, and it included healthy volunteers aged 18 years and older.
No, Aflunov is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has not yet completed the clinical trials and regulatory review process required for approval. Therefore, it is not available for prescription or use outside of clinical research settings.