A Phase 2 interventional study of mRNA-1283 and mRNA-1273 in SARS-CoV-2, sponsored by ModernaTX, Inc.. Not yet recruiting at 31 sites in 6 countries. Open to participants aged 6 Months to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by ModernaTX, Inc. · Phase 2, Interventional, and Prevention
This study will evaluate 2 dose levels of mRNA-1283 in participants ≥6 months to \<12 years to determine the optimal dose level per age group.
mRNA-1283 will be administered at 2 different dose levels (Dose Level 1 and Dose Level 2), with mRNA-1273 serving as the active comparator. Dose Level 1 will be the lower dose, and Dose Level 2 will be the higher dose.
The study will consist of 2 cohorts. In Cohort 1, mRNA-1283 will be administered as a single dose to participants aged ≥2 to \<12 years, regardless of prior coronavirus disease 2019 (COVID-19) vaccination status, with mRNA-1273 included as a comparator. In Cohort 2, mRNA-1283 will be administered as a 2-dose series to participants aged ≥6 months to \<2 years who are previously unvaccinated for COVID-19, with mRNA-1273 included as a comparator.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
Participants aged 2 to \<12 years receive one IM dose of on Day 1.
Biological: mRNA-1283
Participants aged 2 to \<12 years receive one IM dose of on Day 1.
Biological: mRNA-1283
Participants aged 2 to \<12 years receive one IM dose of on Day 1.
Biological: mRNA-1273
Participants aged 6 months to \<2 years receive two IM doses 28 days apart (Days 1 and 29).
Biological: mRNA-1283
Participants aged 6 months to \<2 years receive two IM doses of 28 days apart (Days 1 and 29).
Biological: mRNA-1283
Participants aged 6 months to \<2 years receive two IM doses 28 days apart (Day 1 and 29).
Biological: mRNA-1273
Sterile liquid for injection
Sterile liquid for injection
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Day 1 through Day 7; 7 Days following injection
Cohort 1 and Cohort 2: Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Day 1 through Day 28 (Cohort 1); 28 Days following injection (Cohort 2)
Cohort 1 and Cohort 2: Number of Participants with Any Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation from the Study
Time frame: Day 1 through End of Study (Month 13)
Cohort 1 and Cohort 2: Geometric Mean Value of Antibody Level Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Target Variant
Time frame: Day 29 VISIT (Cohort 1), Day 57 VISIT (Cohort 2)
Cohort 1 and Cohort 2: Geometric Mean Fold Rise of Antibody Level Against SARS-CoV-2
Time frame: Day 29 (Cohort 1), Day 57 (Cohort 2)
Cohort 1 and Cohort 2: Number of Participants with Seroresponse Rate
Time frame: Day 29 (Cohort 1), Day 57 (Cohort 2)
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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ModernaTX, Inc.