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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05372588 | Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines | PHASE3 | COMPLETED | 1,340 | — | — | May 25, 2022 | Apr 7, 2024 | Apr 23, 2024 | 19 | Australia |
Microneutralization \[MN\] geometric mean titers (GMTs) with an inhibitory concentration of 50% (MN50) to the Omicron BA.1 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
Seroresponse rates (SRRs) (proportion of participants who achieve ≥ 4-fold increase from baseline \[Day 0\]) in MN50 titer concentrations to the Omicron BA.1 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
Neutralizing antibody (NAb) GMTs to the Omicron BA.5 subvariant, assessed at Day 28 following initial study vaccination.
SRRs in NAb titer concentrations to the Omicron BA.5 subvariant, assessed at Day 28 following initial study vaccination
NAb GMTs to the ancestral (Wuhan) strain, assessed at Day 28 following initial study vaccination.
| Arm | Type | Description |
|---|---|---|
| Group A (NVX-CoV2515 ) | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0. |
| Group B (NVX-CoV2373 ) | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0. |
| Group C (NVX-CoV2515 ) | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0. |
| Group D (NVX-CoV2373) | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0. |
| Group E (BA.1 Bivalent Vaccine) | EXPERIMENTAL | 1 intramuscular (IM) injection of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2515) of 0.5 mL injection volume on Day 0. |
| Group F (NVX-CoV2540) | EXPERIMENTAL | 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90. |
| Group G (NVX-CoV2373) | EXPERIMENTAL | 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90. |
| Group H (NVX-CoV2373 + NVX-CoV2540) | EXPERIMENTAL | 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90. |
| Name | Type | Description |
|---|---|---|
| NVX-CoV2515 | DRUG | Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL). |
| NVX-Cov2373 | DRUG | Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). |
| NVX-CoV2373 + NVX-CoV2515 | DRUG | Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant. |
| NVX-CoV2540 | DRUG | Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). |
| NVX-CoV2373 + NVX-CoV2540 | DRUG | Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant. |
Part 1 Inclusion Criteria: To be included in this study, each individual must satisfy all the following criteria: 1. Adults ≥ 18 and ≤ 64 years of age at screening. 2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. Female participants o...