Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NanoFlu · 2 trials · 2 indications
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.
Number of participants that reported all adverse event (AE) profile (including adverse changes in clinical laboratory parameters) ; medically-attended adverse event (MAE), serious adverse event (SAE), and significant new medical condition (SNMC) post dosing.
Number of participants with solicited local and systemic adverse events over the 7 days post-injection
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMTs.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMR.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SCRs.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SPRs. Seroprotection rate (SPR) - defined as the number of subjects with an HAI titer ≥ 1:40.
| 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. |
| Group A | EXPERIMENTAL | Low dose NanoFlu - Day 0; Fluzone HD - Day 21 |
| Group B | EXPERIMENTAL | High dose NanoFlu - Day 0; Fluzone HD - Day 21 |
| Group C | ACTIVE_COMPARATOR | Fluzone HD - Day 0; Saline - Day 21 |
| 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. |
| Fluzone HD - Day 0 | BIOLOGICAL | Vaccine |
| Fluzone HD - Day 21 | BIOLOGICAL | Vaccine |
| Saline - Day 21 | OTHER | Placebo |
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...
NanoFlu is an investigational recombinant trivalent nanoparticle influenza vaccine being developed for the prevention of influenza in older adults. It is designed to be administered to adults aged 60 years and older, with clinical trials evaluating its safety and immunogenicity in this population.
NanoFlu is being developed by Novavax, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol NVAX. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in older adult populations.
NanoFlu is in clinical development, with a Phase 1 trial completed and a Phase 3 pivotal trial also completed. The Phase 3 trial evaluated the vaccine in older adults aged 65 years and older, and the Phase 1 trial assessed safety and immunogenicity in adults aged 60 years and older.
NanoFlu has been evaluated in two completed clinical trials. The first, NCT03293498, was a Phase 1 study of a recombinant trivalent nanoparticle influenza vaccine with Matrix M-1 adjuvant in 330 adults aged 60 years and older. The second, NCT04120194, was a Phase 3 pivotal trial in 2,654 older adults aged 65 years and older.
NanoFlu is not FDA approved. It is an investigational vaccine that has completed clinical trials, including a Phase 3 pivotal trial, but approval status has not been established. The vaccine remains in clinical development and has not been authorized for commercial use.