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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06354998 | A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults | PHASE3 | COMPLETED | 217 | — | — | Apr 8, 2024 | May 10, 2024 | May 25, 2025 | 7 | Australia |
Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values reported greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 38 arbitrary unit (AU)/milliliter (mL) and ULOQ was 6960 AU/mL. 95% confidence interval (CI) of GM value was calculated based on the t-distribution of the log-transformed values for antibodies, then back transformed to the original scale for presentation.
| Arm | Type | Description |
|---|---|---|
| Investigational mRNA-1273.815 | EXPERIMENTAL | Participants will receive Investigational mRNA-1273.815 by intramuscular injection. |
| Licensed Spikevax Vaccine | ACTIVE_COMPARATOR | Participants will receive a licensed Spikevax vaccine by intramuscular injection. |
| Name | Type | Description |
|---|---|---|
| Investigational mRNA-1273.815 | BIOLOGICAL | Sterile solution for injection |
| Licensed Spikevax Vaccine | BIOLOGICAL | Commercially available formulation |
Inclusion Criteria: * Participants of childbearing potential may be enrolled in the study if the participant fulfills all of the following criteria: 1. Has a negative pregnancy test on the day of injection prior to vaccine dose being administered (Day 1). 2. Has practiced adequate contraceptio...