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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
300
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)
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