Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00973700 | Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years) | PHASE3 | COMPLETED | 784 | — | — | Aug 1, 2009 | Oct 1, 2010 | Dec 2, 2015 | 1 | Costa Rica |
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).
| 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 |
| 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 ...