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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06409663 | A Strain Change Study for SARS-CoV-2 rS Vaccines | PHASE3 | COMPLETED | 60 | — | — | Oct 14, 2024 | Apr 17, 2025 | Jul 18, 2025 | 2 | United States |
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...