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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04120194 | Phase 3 Pivotal Trial of NanoFlu™ in Older Adults | PHASE3 | COMPLETED | 2,654 | — | — | Oct 14, 2019 | Dec 13, 2020 | May 6, 2023 | 19 | United States |
Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) expressed as GMFR on Day 28
Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) summarized in terms of SCR on Day 28
Number of subjects with solicited local and systemic AEs over 7 days post-injection (ie, Day 0 through Day 6, inclusive).
Number of subjects with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) - including AESIs - through 1-year post-injection.
Number of subjects with MAEs, SAEs, and SNMCs - including AESIs.
| Arm | Type | Description |
|---|---|---|
| NanoFlu | EXPERIMENTAL | NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. |
| Fluzone Quadrivalent | ACTIVE_COMPARATOR | Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. |
| Name | Type | Description |
|---|---|---|
| NanoFlu | BIOLOGICAL | Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season. |
| Fluzone Quadrivalent | BIOLOGICAL | Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season. |
Inclusion Criteria: 1. Clinically-stable adult male or female, ≥ 65 years of age. Subjects may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by: * Ambulatory status, living independently in the community or in a residential facility providing minimal assi...