Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05975060 | A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. | PHASE2 | COMPLETED | 660 | — | — | Sep 7, 2023 | May 20, 2024 | May 30, 2024 | 30 | United States |
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...