Recruiting
Phase 4

mRNA-1283 & mRNA-1273

Sponsor:

Moderna

Code:

NCT07863635

Conditions

SARS-CoV-2

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

mRNA-1273

mRNA-1283

Study Details

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

Conditions

SARS-CoV-2

Study ID

NCT07863635

Start date

Oct 9, 2026

Status verified date

Oct, 2026

Completion date

Dec 11, 2026

Anticipated

Primary completion date

Dec 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

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 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:

  • 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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: mRNA-1273 (Variant Formulation)

Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.

experimental: mRNA-1283 (Variant Formulation)

Participants will receive a single IM injection of mRNA-1283 on Day 1.

Interventions

mRNA-1273

Sterile liquid for injection

mRNA-1283

Sterile liquid for injection

Primary outcome measure

  • Geometric Mean Titer (GMT) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation [ Time Frame: Day 29 ]
  • Geometric Mean Fold Rise (GMFR) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation [ Time Frame: Day 29 ]

Central Contacts and Locations

Central contacts

Moderna WeCareTeam

+1-866-663-3762WeCareClinicalTrials@modernatx.com

Locations

Delricht Research @ Overland

Recruiting

Overland Park, Kansas, United States, 66209

Delricht Research @ Louisville

Recruiting

Louisville, Kentucky, United States, 40205

Delricht Research @ Charlotte

Recruiting

Charlotte, North Carolina, United States, 28210

Delricht Research @ Magnolia Family Medicine

Recruiting

Hendersonville, Tennessee, United States, 37075

Delricht Research @ Zomnir Family Medicine

Recruiting

Prosper, Texas, United States, 75078

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Keywords

  • mRNA-1273
  • mRNA-1283
  • SARS-CoV-2
  • mRNA vaccine
  • Coronavirus
  • Messenger RNA
  • COVID-19
  • COVID-19 Vaccine
  • Moderna
  • SPIKEVAX®
  • mNEXSPIKE®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.