Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MF59-eH1N1_f · 3 trials · 2 indications
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).
CBER guidance (\<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
| Arm | Type | Description |
|---|---|---|
| 2x7.5adj | EXPERIMENTAL | Two doses of MF59 adjuvanted (adj) A/H1N1 |
| 7.5adj_1_8 | EXPERIMENTAL | MF59 adjuvanted (adj) A/H1N1 on days 1 and 8 |
| 7.5adj_1_22 | EXPERIMENTAL | MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22 |
| 15_1_22 | EXPERIMENTAL | A/H1N1 on study days 1 and 22 |
| 2x15_1_22 | EXPERIMENTAL | Two doses of A/H1N1 (one in each arm) on study days 1 and 22 |
| 3.75_(50)MF59 | EXPERIMENTAL | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| 7.5_(0)MF59 | EXPERIMENTAL | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| 7.5_(50)MF59 | EXPERIMENTAL | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| 15_(0)MF59 | EXPERIMENTAL | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| 7.5 w/o MF59 | EXPERIMENTAL | 0% of MF59 with 7.5 µg A/H1N1 antigen |
| 7.5_(100)MF59 | EXPERIMENTAL | 100% of MF59 with 7.5 µg A/H1N1 antigen |
| 15 w/o MF59 | EXPERIMENTAL | 0% of MF59 with 15 µg A/H1N1 antigen |
| 15_(50)MF59 | EXPERIMENTAL | 50% of MF59 with 15 µg A/H1N1 antigen |
| 15_(100)MF59 | EXPERIMENTAL | 100% of MF59 with 15 µg A/H1N1 antigen |
| 30 w/o MF59 | EXPERIMENTAL | 0% of MF59 with 30 µg A/H1N1 antigen |
| Name | Type | Description |
|---|---|---|
| MF59-eH1N1_f | BIOLOGICAL | MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal |
| eH1N1_f | BIOLOGICAL | Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal |
Inclusion Criteria: * Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months. Exclusion Criteria: * History of serious disease. * History ...
MF59-eH1N1_f is an investigational vaccine being developed for influenza, specifically for the Novel 2009 Influenza H1N1 strain. It is intended to prevent infection caused by the 2009 H1N1 swine flu virus. The vaccine is being studied in various age groups, including children, adolescents, adults, and the elderly.
MF59-eH1N1_f is being developed by Novartis AG, which trades under the ticker NVS. Novartis is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine in different populations.
MF59-eH1N1_f is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The clinical trials for this vaccine have been completed, with no active trials currently ongoing.
MF59-eH1N1_f has been studied in three completed clinical trials. These include NCT00973349, a Phase 2 study in non-elderly and elderly adults; NCT00973700, a Phase 3 study in children, adolescents, and adults; and NCT00996307, a Phase 2 study in children aged 6 to under 36 months. The trials evaluated safety and immunogenicity with and without adjuvant.
MF59-eH1N1_f is a vaccine designed to protect against the Novel 2009 Influenza H1N1, commonly known as swine flu. It is a monovalent subunit vaccine that includes the MF59 adjuvant. The clinical trials for this vaccine were conducted during the 2009 H1N1 pandemic to assess its safety and immune response.