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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01258595 | A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age | PHASE2 | COMPLETED | 300 | — | — | Nov 1, 2010 | Apr 1, 2011 | May 16, 2016 | 5 | United States |
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Seroconversion: For participants with a Day 0 (pre-vaccination) titer \< 10 (1/dilution \[1/dil\]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28. Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Seroprotection was defined as a titer ≥ 40 (1/dilution \[1/dil\]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
| Arm | Type | Description |
|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | EXPERIMENTAL | - |
| Trivalent Inactivated Influenza Vaccine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | BIOLOGICAL | 0.5 mL Intramuscular |
| Trivalent Inactivated Influenza Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 50 to 64 years (inclusive) on the day of vaccination * Informed consent form has been signed and dated * Medically stable * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of c...