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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02553343 | A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older | PHASE2 | COMPLETED | 792 | — | — | Sep 1, 2015 | Apr 4, 2016 | Feb 9, 2018 | 9 | United States |
Solicited injection site: Pain, Redness, Swelling, Induration, and Ecchymosis. Solicited systemic reaction: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Unsolicited adverse events, including serious adverse events, will also be collected
| Arm | Type | Description |
|---|---|---|
| QIV HD1 Group | EXPERIMENTAL | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 1) |
| QIV HD2 Group | EXPERIMENTAL | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 2) |
| TIV HD1 Group | ACTIVE_COMPARATOR | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of licensed High Dose trivalent influenza vaccine |
| TIV HD2 Group | ACTIVE_COMPARATOR | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of investigational High-Dose trivalent influenza vaccine |
| Name | Type | Description |
|---|---|---|
| High-dose quadrivalent influenza virus vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (IM), injected into the deltoid area |
| High-dose influenza virus vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (IM), injected into the deltoid area |
| High-dose trivalent inactivated influenza vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (IM), injected into the deltoid area |
Inclusion Criteria: * Aged ≥ 65 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Participation at the time of trial enrollment (or in the 4 weeks preceding the trial...