Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MF59-eH5N1 · 1 trial · 2 indications
Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer \<10 for HI \[Haemagglutination Inhibition\], area ≤4 mm\^2 for SRH \[Single Radial Haemolysis\]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm\^2 for SRH). Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.
Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.
seroconversion: negative pre-vaccination serum (HI titer \<10, SRH area =\<4 mm\^2)/positive post-vaccination titer (HI titer =\>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.
seroconversion (serocon.): negative pre-vaccination serum (HI titer \<10, SRH area =\<4 mm\^2)/positive post-vaccination titer (HI titer =\>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.
seroconversion (serocon.): negative pre-vaccination serum (HI titer \<10, SRH area =\<4 mm\^2)/positive post-vaccination titer (HI titer =\>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.
| Arm | Type | Description |
|---|---|---|
| Concomitant alone | EXPERIMENTAL | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382. |
| Concomitant +Mixed | EXPERIMENTAL | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382 |
| Concomitant +MF59-eH5N1 | EXPERIMENTAL | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382 |
| Mixed | EXPERIMENTAL | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382 |
| Mixed and mixed | EXPERIMENTAL | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382 |
| Mixed+MF59-eH5N1 | EXPERIMENTAL | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382 |
| MF59-eH5N1+eTIV_a | EXPERIMENTAL | 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382 |
| eTIV_a+MF59-eH5N1 | EXPERIMENTAL | 1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382 |
| Name | Type | Description |
|---|---|---|
| MF59-eH5N1 | BIOLOGICAL | - |
| eTIV_a | BIOLOGICAL | - |
| MF59-eH5N1 + eTIV_a | BIOLOGICAL | - |
Inclusion Criteria: * Healthy subjects
MF59-eH5N1 is an investigational vaccine being developed by Novartis AG (NVS) for pandemic influenza, specifically avian influenza. It is in Phase 2 clinical development and is designed to address pandemic influenza strains. The vaccine is currently being studied in clinical trials to evaluate its immunogenicity, safety, and tolerability.
MF59-eH5N1 is used for the prevention of pandemic influenza, including avian influenza. It is being developed as a prepandemic influenza vaccine to protect against potential pandemic strains. The vaccine is intended for use in adult subjects and is currently being evaluated in clinical trials for its ability to generate an immune response.
MF59-eH5N1 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 trials to evaluate the vaccine's safety and efficacy for pandemic influenza.
MF59-eH5N1 is in Phase 2 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The vaccine is being studied in a completed Phase 2 trial to assess its immunogenicity, safety, and tolerability in adult subjects.
MF59-eH5N1 has been studied in one clinical trial with the identifier NCT00481065. This Phase 2 trial, titled 'Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects,' was conducted in Colombia and enrolled 405 participants. The trial has been completed.
MF59-eH5N1 is a prepandemic influenza vaccine, not a seasonal influenza vaccine. It is specifically designed to target pandemic influenza strains, such as avian influenza. The clinical trial NCT00481065 compared the prepandemic vaccine with a seasonal influenza vaccine to evaluate their immunogenicity and safety.