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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05436834 | A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age | PHASE3 | COMPLETED | 1,807 | — | — | Jun 21, 2022 | Oct 20, 2025 | Nov 26, 2025 | 74 | United States, Argentina +5 |
| Arm | Type | Description |
|---|---|---|
| mRNA-1273.214 (Part 1) | EXPERIMENTAL | Participants who have not been previously vaccinated against SARS-CoV-2, will receive 2 intramuscular (IM) injections of mRNA-1273.214 vaccine on Day 1 and Day 29. |
| mRNA-1273.214 (Part 2) | EXPERIMENTAL | Participants who have previously been vaccinated with a mRNA-1273 primary series, will receive a single IM BD of mRNA-1273.214 vaccine at least 4 months after completion of the mRNA-1273 primary series. |
| mRNA-1273.815 (Part 3) | EXPERIMENTAL | Participants who have previously been vaccinated with an authorized/approved COVID-19 vaccine, will receive a single IM BD of mRNA-1273.815 vaccine on BD Day 1, at least 4 months after the last dose of a COVID-19 vaccine. |
| mRNA-1273.815 (Part 4) | EXPERIMENTAL | Participants in Part 4 Cohort A will receive a single IM injection of mRNA-1273.815 vaccine on Day 1. Participants in Part 4 Cohort B will receive IM injections of mRNA-1273.815 vaccine on Day 1 and Day 29. |
| Name | Type | Description |
|---|---|---|
| mRNA-1273.214 | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1273.815 | BIOLOGICAL | Sterile liquid for injection |
Inclusion Criteria: * The participant is 6 months to \<6 years for Parts 1, 2, and 3; 2 years to \<5 years for Part 4A; and 6 months to \<2 years for Part 4B at the time of consent (Screening Visit). Note: for Part 1, participant must be at least 6 months old and must not have reached 6 years of ag...