SARS-CoV-2Phase 4NCT07863635
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
A Phase 4 study testing mRNA-1273 and mRNA-1283 in people with SARS-CoV-2, run by ModernaTX, Inc. at 5 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- mRNA-1273 and mRNA-1283
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Oct 2026to 9 Jan 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 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:
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- COVID-19 vaccine within 6 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Delricht Research @ Olabisi Badmus
Charlotte, North Carolina, 28210
Delricht Research @ Magnolia Family Medicine
Hendersonville, Tennessee, 37075
Delricht Research @ Derby City Direct Primary Care
Louisville, Kentucky, 40205
Delricht Research @ Concierge and Direct Primary Care
Overland Park, Kansas, 66209
Delricht Research @ Zomnir Family Medicine
Prosper, Texas, 75078
About this study
Official title: A Phase 3b/4, Open-label Study to Assess the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
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
- Conditions
- SARS-CoV-2
- Being tested
- mRNA-1273, mRNA-1283
- Keywords
- mRNA-1273, mRNA-1283, SARS-CoV-2, mRNA vaccine, Coronavirus, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna, SPIKEVAX®, mNEXSPIKE®
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1273Biological
Also called SPIKEVAX®
Sterile liquid for injection
mRNA-1283Biological
Also called mNEXSPIKE®
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1273 (Variant Formulation) | Experimental | Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1. Receives: Biological: mRNA-1273 |
| mRNA-1283 (Variant Formulation) | Experimental | Participants will receive a single IM injection of mRNA-1283 on Day 1. Receives: Biological: mRNA-1283 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation
Measured: Day 29
Geometric Mean Fold Rise (GMFR) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation
Measured: Day 29
Secondary outcomes (2)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Day 1 through Day 29
Number of Participants with Serious AEs (SAEs), AEs Leading to Study Withdrawal, and AEs of Special Interest (AESIs)
Measured: Day 1 through Day 29/End of Study (EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start9 Oct 2026 (estimated)
- Primary completion9 Jan 2027 (estimated)
- Study completion9 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863635
- Sponsor's protocol ID
- mRNA-1273_1283-P402
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No