A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing V
The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
| Condition(s) | SARS-CoV-2 |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). |
| Who can participate | Key Inclusion Criteria: * mRNA-1273.167 and mRNA-1273.712: Previously vaccinated adults aged ≥18 years * mRNA-1273.251: Participants ≥65 years of age, ≥12 to \<65 years of age, or ≥6 months to \<12 years of age with at least 1 risk factor for severe outcomes from COVID-19. * mRNA-1273.261: ≥65 years of age at the time of signing the informed consent or ≥18 to \<65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19. * Able to comply with study procedures based on the assessment of the Investigator. * Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: * Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to va |
| Ages | 6 Months |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | ModernaTX, Inc. |
| Locations | Atlanta, Georgia, United States; Decatur, Georgia, United States; Baton Rouge, Louisiana, United States; Gulfport, Mississippi, United States; Omaha, Nebraska, United States; Richmond, Virginia, United States |
| Start date | 2024-09-09 |
| NCT ID | NCT06585241 |
| Official listing | https://clinicaltrials.gov/study/NCT06585241 |