Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SARS-CoV-2 rS
NVX-CoV2705 Vaccine · 1 trial · 1 indication
Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following vaccination.
Incidence, severity, and relationship of any unsolicited AEs through 28 days after vaccination.
Incidence and severity of treatment-related MAAEs, adverse events of special interest and serious adverse events interest (AESIs; predefined list, including PIMMCs, myocarditis and/or pericarditis), and serious adverse events (SAEs) through day 180 or end of study (EoS).
| Arm | Type | Description |
|---|---|---|
| NVX-CoV2705 vaccine (5 µg ) | EXPERIMENTAL | NVX-CoV2705 COVID-19 vaccine will contain rS antigen from the JN.1 subvariant of SARS-CoV-2 |
| Name | Type | Description |
|---|---|---|
| NVX-CoV2705 Vaccine | BIOLOGICAL | All injections will be administered in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant at each injection. |
Inclusion Criteria: 1. Adults ≥ 18 years of age at time of study vaccination. 2. Previously vaccinated with ≥ 3 doses of an authorized/approved COVID-19 vaccine with the last dose administered ≥ 6 months prior to study vaccination. 3. Willing and able to give informed consent prior to study enrollm...
NVX-CoV2705 Vaccine is an investigational vaccine developed by Novavax, Inc. for Severe Acute Respiratory Syndrome Coronavirus 2 Infection, the virus that causes COVID-19. It is a strain change study vaccine evaluated in a Phase 3 clinical trial. It is not an approved product and remains in clinical development.
NVX-CoV2705 Vaccine is being studied for the prevention of Severe Acute Respiratory Syndrome Coronavirus 2 Infection, the virus responsible for COVID-19. The Phase 3 strain change study enrolled healthy adult volunteers aged 18 years and older in the United States. The vaccine is investigational and has not been approved for use.
NVX-CoV2705 Vaccine is developed by Novavax, Inc., which trades on the Nasdaq under the ticker NVAX. Novavax is the sponsor of the Phase 3 strain change study evaluating the vaccine. The company is a vaccine-focused biotechnology firm.
NVX-CoV2705 Vaccine is in Phase 3 clinical development. Its single registered trial, NCT06409663, titled A Strain Change Study for SARS-CoV-2 rS Vaccines, is listed as completed. The vaccine is investigational and is not an approved product.
NVX-CoV2705 Vaccine has been evaluated in one registered clinical trial, NCT06409663, titled A Strain Change Study for SARS-CoV-2 rS Vaccines. This Phase 3 trial enrolled 60 healthy adult volunteers aged 18 years and older in the United States and is listed as completed. It was an uncontrolled study.