Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Quad-NIV
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 nanoparticle influenza vaccine being developed for the prevention of influenza in older adults. It is designed to address seasonal influenza, including in adults aged 60 years and older, and has been evaluated in clinical trials in the United States.
NanoFlu is a recombinant nanoparticle vaccine that targets influenza virus hemagglutinin proteins. It is formulated with the Matrix-M adjuvant to enhance immune responses. The vaccine is designed to induce immunity against seasonal influenza strains, particularly in older adults who may have weaker responses to standard vaccines.
NanoFlu is being developed by Novavax, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol NVAX. Novavax is responsible for the research, clinical development, and manufacturing of the vaccine candidate.
NanoFlu is an investigational vaccine that has completed Phase 1 and Phase 3 clinical trials. The Phase 3 pivotal trial in older adults has been completed, but NanoFlu is not yet approved by the FDA and remains in clinical development as an investigational product.
NanoFlu has been evaluated in two completed clinical trials. NCT03293498 was a Phase 1 study of a recombinant trivalent nanoparticle influenza vaccine with Matrix-M adjuvant in adults aged 60 years and older. NCT04120194 was a Phase 3 pivotal trial of NanoFlu in older adults aged 65 years and older.
NanoFlu is a recombinant trivalent nanoparticle influenza vaccine, as described in the Phase 1 trial. It incorporates three influenza strains and uses the Matrix-M adjuvant. The Phase 3 trial refers to it as NanoFlu, indicating that the product name applies to this specific vaccine formulation.