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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02256488 | Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects | PHASE3 | COMPLETED | 1,561 | — | — | Sep 1, 2014 | Dec 1, 2014 | Jun 11, 2019 | 24 | United States |
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
| Arm | Type | Description |
|---|---|---|
| TIVc-Lot A | EXPERIMENTAL | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A |
| TIVc-Lot B | EXPERIMENTAL | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B |
| TIVc-Lot C | EXPERIMENTAL | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C |
| TIVf | ACTIVE_COMPARATOR | Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf |
| Name | Type | Description |
|---|---|---|
| TIVc_LOT A | BIOLOGICAL | Single IM (Intramuscular) administration dose of 0.5 mL of TIVc |
| TIVc_LOT B | BIOLOGICAL | Single IM administration dose of 0.5 mL of TIVc |
| TIVc_LOT C | BIOLOGICAL | Single IM administration dose of 0.5 mL of TIVc |
| TIVf | BIOLOGICAL | Single IM administration dose of 0.5 mL of TIVf |
Inclusion Criteria: * Males or females 18 through 49 years of age. * Subjects having provided informed consent. * Individuals in good health Exclusion Criteria: * Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, i...