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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05875701 | Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines | PHASE3 | COMPLETED | 147 | — | — | Mar 28, 2023 | Nov 11, 2023 | Jun 26, 2025 | 5 | United States |
| NCT05463068 | Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults | PHASE3 | COMPLETED | 911 | — | — | Jul 11, 2022 | Sep 1, 2022 | Apr 17, 2026 | 30 | United States |
| NCT05925127 | Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines | PHASE2 | COMPLETED | 994 | — | — | Oct 16, 2023 | May 21, 2024 | Dec 13, 2024 | 50 | United States |
Neutralizing Antibody responses to ancestral strain Novavax vaccine (NVX-CoV2373) for the participants in the ancestral strain NVX-2373 group and NVX-CoV2540 group at Day 29
Serum Immunoglobulin G (IgG) geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.
Neutralizing antibody To determine if the combination of antigen and adjuvant levels of NVX-CoV2601 GMTR against the Omicron subvariant XBB.1.5 superior(LB of the 95% CI for GMTR \> 1.0) to that elicited by NVX-CoV2373
Neutralizing antibody SRR against the Omicron XBB.1.5 subvariant elicited by NVXCoV2601 is non-inferior (NI)to the SRR elicited by NVX-CoV2373in participants ≥ 50 years of age previously vaccinated with ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNA vaccine.
| Arm | Type | Description |
|---|---|---|
| NVX CoV2373 (Ancestral strain) | EXPERIMENTAL | 1dose of NVX-COV2373 on Day 1 |
| Updated COVID-19 Vaccine | EXPERIMENTAL | 1dose of updated COVID-19 vaccine on Day 1 |
| Lot 1 | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. |
| Lot 2 | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. |
| Lot 3 | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. |
| Group-A Monovalent NVX-CoV2373 (5 μg) | EXPERIMENTAL | The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant |
| Group-B Monovalent NVX-CoV2601 (5 μg) | EXPERIMENTAL | Monovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant) |
| Group-C Monovalent NVX-CoV2601 (5 μg) | EXPERIMENTAL | Monovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant) |
| Group-D Monovalent NVX-CoV2601 (35 μg) | EXPERIMENTAL | Monovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant) |
| Group-E Monovalent NVX-CoV2601(35) | EXPERIMENTAL | Monovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant) |
| Group-F Monovalent NVX-CoV2601 (50 μg) | EXPERIMENTAL | Monovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant) |
| Group-G Bivalent XBB.1.5 | EXPERIMENTAL | Bivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine |
| Name | Type | Description |
|---|---|---|
| NVX-CoV2373 | BIOLOGICAL | 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1 |
| SARS-CoV-2 rS antigen/Matrix-M Adjuvant | BIOLOGICAL | 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1 |
| NVX-CoV2373 (5μg) | BIOLOGICAL | Coformulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 μg/mL and 100 μg adjuvant per mL, respectively |
| NVX-CoV2601 (5μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 50 µg Matrix-M adjuvant. |
| NVX-CoV2601(5μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 75 µg Matrix-M adjuvant. |
| NVX-CoV2601 (35μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 50 µg Matrix-M adjuvant. |
| NVX-CoV2601(35μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 75 µg Matrix-M adjuvant. |
| NVX-CoV2601(50μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 50 µg of antigen with 100 µg Matrix-M adjuvant |
| Bivalent BA.4/5 | BIOLOGICAL | The bivalent BA.4/5 (or recommended mRNA vaccine at the time of the conduct of this study) Omicron subvariant/prototype licensed mRNA vaccine will be procured and stored per the manufacturer's instructions. For this vaccine group, treatment will be administered open label as a single IM injection |
Inclusion Criteria: To be included in this study, each individual must satisfy all the following criteria: 1. Adults 18 to 49 years (inclusive) of age at the time of vaccination in Study 307 who received two or three doses of mRNA prior to enrollment in Study 307, then one dose of ancestral strain...