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.
Participant is male or female, between ≥2 years to <12 years of age for Cohort 1 or ≥6 months to <2 years of age for Cohort 2 (calculated from date of birth) at the time of signing the informed consent/assent.
Participant is in good general health as determined by medical evaluation including medical history and physical examination. Participants with chronic but stable conditions (eg, gastroesophageal reflux disease, asthma) may be eligible to enroll, provided the condition is well-controlled and not expected to interfere with study participation or outcomes.
For participants in Cohort 2: the participant was born at ≥37 weeks, with a minimum birth weight of 2.5 kilograms, without fetal growth restriction.
Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as premenarche. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy. If childbearing potential is unclear (for example, amenorrhea in athletes) and a menstrual cycle cannot be confirmed before first dose of study intervention, additional evaluation should be considered.
History of SARS-CoV-2 infection within 3 months prior to enrollment.
Acutely ill or febrile (temperature ≥38.0℃elsius [100.4°Fahrenheit]) within 72 hours prior to or at the screening visit or Day 1. Participants who are acutely ill or febrile may be scheduled for a separate dosing visit within the protocol-specified window for screening and will retain their initially assigned participant number. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator.
Any medical, psychiatric, or occupational condition, including reported history of drug, or alcohol abuse in the parent(s)/ legally authorized representative(s), that, in the opinion of the investigator, might pose additional risk due to child's participation in the study, could interfere with safety assessments, or could interfere with the interpretation of study results.
Receipt of the 2026-2027 formulation of a COVID-19 vaccine at any time prior to enrollment.
Parallel
mRNA-1283
Biological/VaccineSterile liquid for injection
mRNA-1273
Biological/VaccineSterile liquid for injection
6
Treatment groupsSee each treatment group below.
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Cohort 1 and Cohort 2: Number of Participants with Unsolicited Adverse Events (AEs)
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
Cohort 1 and Cohort 2: Geometric Mean Value of Antibody Level Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Target Variant
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