Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Novavax COVID-19 Vaccine · 1 trial · 1 indication
Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Numbers of participants reporting unsolicited AEs and MAAEs over 21 days post-vaccination.
Numbers of participants with treatment-related MAAEs, AESIs (including PIMMC and myocarditis and/or pericarditis), and SAEs will be collected for 12 months (approximately 364 days) post-vaccination.
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Days 0 and 28
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Days 28
Percentage of Participants With a (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose for 3 vaccine-homologous influenza strain on Days 28
Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28
| Arm | Type | Description |
|---|---|---|
| CIC Vaccine | EXPERIMENTAL | A single 0.5 mL IM injection on Day 0 |
| Novavax COVID-19 Vaccine | EXPERIMENTAL | A single 0.5 mL IM injection on Day 0 |
| tNIV Vaccine | EXPERIMENTAL | A single 0.5 mL IM injection on Day 0 |
| Fluzone High-Dose | EXPERIMENTAL | A single 0.5 mL IM injection on Day 0 |
| Name | Type | Description |
|---|---|---|
| CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant | BIOLOGICAL | CIC will contain SARs-CoV-2 antigen (35 μg), tNIV antigens (2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains; 60 μg/strain |
| Novavax COVID-19 Vaccine | BIOLOGICAL | Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant |
| tNIV Vaccine | BIOLOGICAL | 2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains (60 μg/strain), and Matrix-M adjuvant (75 μg) |
| Fluzone High Dose | BIOLOGICAL | Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per strain |
Inclusion Criteria To be included in this study, each individual must satisfy all the following criteria: 1. Willing and able to give informed consent prior to study enrollment. 2. Medically stable adult male or female ≥ 65 years of age at Screening. 3. Participants may have 1 or more chronic medi...
Novavax COVID-19 Vaccine is an investigational vaccine being studied for the prevention of COVID-19. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities. The vaccine is designed to generate an immune response against the SARS-CoV-2 virus, which causes COVID-19.
Novavax COVID-19 Vaccine 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 adults aged 65 years and older.
Novavax COVID-19 Vaccine is in Phase 3 clinical development. It is an investigational product, meaning it has not yet received regulatory approval for use in the general population. The Phase 3 trial has been completed, and the company is analyzing the results to determine next steps.
Novavax COVID-19 Vaccine was evaluated in a Phase 3 clinical trial with the identifier NCT06291857. This study, titled 'A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine,' enrolled 9,320 participants aged 65 years and older in Australia and New Zealand. The trial has been completed.
No, Novavax COVID-19 Vaccine is not a monoclonal antibody. It is a vaccine, which is a different modality. Vaccines work by stimulating the body's immune system to produce a protective response against a pathogen, whereas monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off viruses.