NCT07863635 A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
| NCT ID | NCT07863635 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | ModernaTX, Inc. |
| Condition | SARS-CoV-2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-10-09 |
| Primary Completion | 2026-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 600 participants in total. It began in 2026-10-09 with a primary completion date of 2026-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment
Eligibility Criteria
Inclusion Criteria: * ≥65 years of age at the time of signing the informed consent OR ≥12 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. * Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol. Exclusion Criteria: * History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment. * Acutely ill or febrile within 72 hours prior to or at Day 1. * History of a diagnosis or conditions that in the Investigator's opinion could affect participant's safety, assessment of endpoints, assessment of immune response, or adherence to study procedures. * Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections. * History of coagulopathy or bleeding disorder that is considered a contraindication to IM injection or phlebotomy. * Receipt of any of the following: * COVID-19 vaccine within 3 months prior to enrollment, * Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention, * Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study, * Systemic immunoglobulins, long-acting biological therapies that affect immune responses, or blood products within 90 days prior to the Day 1 Visit or plans for receipt during the study. Note: Additional protocol-defined inclusion/exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07863635 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying SARS-CoV-2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07863635 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07863635 currently recruiting?
Yes, NCT07863635 is actively recruiting participants. Contact the research team at WeCareClinicalTrials@modernatx.com for enrollment information.
Where is the NCT07863635 trial being conducted?
This trial is being conducted at Overland Park, United States, Louisville, United States, Charlotte, United States, Hendersonville, United States and 1 additional location.
Who is sponsoring the NCT07863635 clinical trial?
NCT07863635 is sponsored by ModernaTX, Inc.. The trial plans to enroll 600 participants.