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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00972816 | Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years) | PHASE2 | COMPLETED | 1,357 | — | — | Sep 1, 2009 | Oct 1, 2010 | Apr 14, 2016 | 35 | United States, Mexico |
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for \<65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
| Arm | Type | Description |
|---|---|---|
| 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 |
| 7.5_(100) MF59 | EXPERIMENTAL | 7.5 μg A/H1N1 antigen with 100% 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 |
| 15_(50)MF59 | EXPERIMENTAL | 15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 |
| 15_(100) MF59 | EXPERIMENTAL | 15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22 |
| 30_(0) MF59 | EXPERIMENTAL | 30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 |
| Name | Type | Description |
|---|---|---|
| MF59-eH1N1 | BIOLOGICAL | MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus). |
Inclusion Criteria: * Children 3 to \< 9 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 of serious reaction fol...