Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the prevention of Severe Acute Respiratory Syndrome Coronavirus 2 Infection, the disease caused by SARS-CoV-2. It is a recombinant protein vaccine developed by Novavax, Inc. and is currently in Phase 3 clinical development.
NVX-CoV2705 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 for the prevention of SARS-CoV-2 infection.
NVX-CoV2705 Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The vaccine is being studied for the prevention of Severe Acute Respiratory Syndrome Coronavirus 2 Infection.
NVX-CoV2705 Vaccine has been evaluated in one completed Phase 3 clinical trial, identified as NCT06409663, titled 'A Strain Change Study for SARS-CoV-2 rS Vaccines'. This trial enrolled 60 healthy adult participants in the United States and was an uncontrolled, non-randomized study.
NVX-CoV2705 Vaccine is a strain change study vaccine for SARS-CoV-2, related to Novavax's recombinant protein vaccine platform. The clinical trial NCT06409663 was designed to evaluate a strain change for SARS-CoV-2 rS vaccines, indicating it is a variant-adapted version of the company's vaccine technology.