A Phase 4 interventional study of mRNA-1283.251 Variant-containing Formulation in COVID-19, sponsored by ModernaTX, Inc.. Completed at 5 sites in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by ModernaTX, Inc. · Phase 4, Interventional, and Prevention
The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.
This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity of variant-containing formulations of the mRNA-1283 COVID-19 vaccine. As different variant-containing vaccine formulations will be evaluated, each study intervention (for example, updated mRNA-1283 COVID-19 vaccine) will be described in the subprotocol. For each evaluation of an updated variant vaccine, a new subprotocol will be generated.
Subprotocol 01 is a single arm study to evaluate immunogenicity and safety of mRNA-1283 (COVID-19 vaccine) 2025-2026 formula in individuals aged ≥65 years and ≥12 to \<65 years with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19.
The study included Parts A and B. Part A enrollment was discontinued due to addition of Part B to evaluate the safety and immunogenicity of variant-containing mRNA-1283 using a hypothesis driven study endpoint with reactogenicity data collection and longer safety follow up in Part B.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 832 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →ModernaTX, Inc. is the lead sponsor of 112 studies on the registry; 14 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 32 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subprotocol 1:
Participants who are assigned female at birth or could become pregnant:
i) Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.
ii) Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
iii) Has agreed to continue adequate contraception through 28 days following vaccine administration.
Exclusion Criteria:
Subprotocol 1:
Note: Other protocol-specified inclusion and exclusion criteria may apply.
Participants will receive an intramuscular (IM) injection of a mRNA-1283.251 variant-containing formulation.
Biological: mRNA-1283.251 Variant-containing Formulation
Sterile liquid for injection
Also known as: mNEXSPIKE®
Subprotocol 1: Part A - Geometric Mean (GM) Value of Neutralizing Antibody (nAb) Against Vaccine-matched COVID-19 Variants
Time frame: Day 29
Subprotocol 1: Part A - Geometric Mean Fold Rise (GMFR) of nAb Against Vaccine-matched COVID-19 Variants
Time frame: Baseline to Day 29
Subprotocol 1: Part B - GMFR of nAb Against Vaccine-matched COVID-19 Variants
Time frame: Baseline to Day 29
Subprotocol 1: Part A - Seroresponse Rate (SRR) of nAb Against Vaccine-matched COVID-19 Variants
Time frame: Baseline to Day 29
Subprotocol 1: Part A - Number of Participants with Unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interests (AESIs), and AEs Leading to Study Withdrawal
Time frame: Day 1 through Day 29
Subprotocol 1: Part B - Number of Participants with Unsolicited AEs
Time frame: Day 1 through Day 29
Subprotocol 1: Part B - Number of Participants with SAEs, AESIs, and AEs Leading to Study Withdrawal
Time frame: Day 1 through Day 181
Subprotocol 1: Part B - Geometric Mean Ratio (GMR) of nAb Against Vaccine-matched COVID-19 Variants Between Participants Aged ≥12 to <65 Years and Those Aged ≥65 Years
Time frame: Day 29
Subprotocol 1: Part B - Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: 7 days post vaccination
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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ModernaTX, Inc.