Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XBB.1.5 Vaccine · 1 trial · 1 indication
Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine assessed at Day 28 following study vaccination.
SRRs (proportion of seroconverted participants) in ID 50 titers to the NVXCoV2601 vaccine assessed at Day 28 following the study vaccination.
SRRs (proportion of seroconverted participants) in ID 50 titers to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.
ID 50 GMTs to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.
| Arm | Type | Description |
|---|---|---|
| Group-A XBB.1.5 Vaccine (Booster) | EXPERIMENTAL | The Monovalent \[5 μg/50 μg\] NVX-CoV2601 XBB.1.5 Vaccine (Booster) |
| Group-B The monovalent XBB.1.5 Vaccine (Single Dose). | ACTIVE_COMPARATOR | Group-B The monovalent \[5 μg/50 μg\] NVX-CoV2601 XBB.1.5 Vaccine (Single Dose). |
| Name | Type | Description |
|---|---|---|
| XBB.1.5 Vaccine (Booster) | BIOLOGICAL | Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent \[5 μg/50 μg\] NVX-CoV2601) XBB.1.5 Vaccine (Booster) |
| XBB.1.5 Vaccine (single dose) | BIOLOGICAL | Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent \[5 μg/50 μg\] NVX-CoV2601) XBB.1.5 Vaccine ( single dose) |
Inclusion Criteria: 1. Adults ≥ 18 years of age at time of study vaccination. 2. Part 1: Previously vaccinated with ≥ 3 doses of the Moderna and/or Pfizer /BioNTech prototype monovalent and/or BA.4/5 containing bivalent COVID-19 vaccines with the last dose administered ≥ 90 days prior to study vacc...
XBB.1.5 Vaccine is an investigational COVID-19 vaccine being developed by Novavax, Inc. (NVAX) for the prevention of COVID-19. It is designed as a booster dose to be given to previously vaccinated individuals and also evaluated in unvaccinated participants. The vaccine is currently in Phase 2 clinical development.
XBB.1.5 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 safety and immunogenicity of this COVID-19 vaccine candidate.
XBB.1.5 Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the vaccine is being studied as a booster dose for COVID-19.
XBB.1.5 Vaccine has been studied in one completed Phase 2 clinical trial with the identifier NCT05975060. This trial evaluated the safety and immunogenicity of the vaccine as a booster dose in previously vaccinated participants and in unvaccinated participants. The trial enrolled 660 participants in the United States.
XBB.1.5 Vaccine is a COVID-19 vaccine candidate developed by Novavax, Inc. It is specifically designed to target the Omicron XBB.1.5 subvariant. The vaccine is being evaluated as a booster dose to enhance immune responses against this variant in previously vaccinated individuals.