Recruiting
Phase 2

mRNA-1283

Sponsor:

Moderna

Code:

NCT07808697

Conditions

SARS-CoV-2

Eligibility Criteria

Sex: All

Age: 0 - 11

Healthy Volunteers: Accepted

Interventions

mRNA-1283

mRNA-1273

Study Details

Brief summary:

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.

Conditions

SARS-CoV-2

Study ID

NCT07808697

Start date

Sep 4, 2026

Status verified date

Oct, 2026

Completion date

Aug 30, 2029

Anticipated

Primary completion date

Aug 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 11

Healthy Volunteers: Accepted

Key Inclusion Criteria:

  • 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.
  • Female participants who have reached menarche may be enrolled in the study if all of the following criteria are fulfilled:
  • Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours before the study intervention.
  • Is not currently chest/breastfeeding.
  • Has been using a highly effective contraceptive method or has abstained from all activities that could lead to pregnancy for at least 28 days prior to the study injection (Day 1). The investigator should evaluate the potential for contraceptive method failure (for example, noncompliance, recently initiated) in relationship to the study injection.
  • Has agreed to continue adequate contraception through the end of study. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Key Exclusion Criteria:

  • 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.
  • Receipt of any COVID-19 vaccine within 6 months prior to enrollment.
  • Receipt of any nonstudy vaccination within 14 days (28 days for live vaccines) prior to study intervention or plans to receive a nonstudy vaccine through 14 days after administration of study intervention.
  • Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 (baseline) or plans to do so during the study.
  • Received systemic immunoglobulins or blood products within 90 days prior to the screening visit or plans to receive them during the study. Exception: Nirsevimab and clesrovimab are allowed.
  • For infants who receive breast milk, maternal receipt of systemic immunosuppressive therapy during lactation. This includes ≥10 milligrams/day of prednisone or equivalent for 14 days or more, or other immunomodulating agents (for example, biologics, calcineurin inhibitors, disease-modifying agents) that may be transferred via breastmilk and impact infant immune development or vaccine response.
  • Has participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study.
  • Has been placed under the control or protection of an agency, organization, institution, or entity by the courts, the government, or a government body, acting in accordance with powers conferred on them by laws, and regulation. Does not include a child who is adopted or has an appointed legal guardian.
  • Receipt of any nonstudy vaccination within 14 days (28 days for live vaccines) prior to study intervention or plans to receive a nonstudy vaccine through 14 days after administration of study intervention.
  • History of any myocarditis, pericarditis, or myopericarditis

Note: Other inclusion and 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: Cohort 1: mRNA-1283 Dose Level 1

Participants aged 2 to <12 years receive one IM dose of on Day 1.

experimental: Cohort 1: mRNA-1283 Dose Level 2

Participants aged 2 to <12 years receive one IM dose of on Day 1.

active comparator: Cohort 1: mRNA-1273

Participants aged 2 to <12 years receive one IM dose of on Day 1.

experimental: Cohort 2: mRNA-1283 Dose Level 1

Participants aged 6 months to <2 years receive two IM doses 28 days apart (Days 1 and 29).

experimental: Cohort 2: mRNA-1283 Dose Level 2

Participants aged 6 months to <2 years receive two IM doses of 28 days apart (Days 1 and 29).

active comparator: Cohort 2: mRNA-1273

Participants aged 6 months to <2 years receive two IM doses 28 days apart (Day 1 and 29).

Interventions

mRNA-1283

Sterile liquid for injection

mRNA-1273

Sterile liquid for injection

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Locations

Orange County Research Center

Recruiting

Ontario, California, United States, 91762

Hope Research Network

Recruiting

Miami, Florida, United States, 33166

Spotlight Research Center - Internal Medicine

Recruiting

Miami, Florida, United States, 33167

Indago Research and Health Cen

Recruiting

Miami Lakes, Florida, United States, 33016

MplusM - D&H Tamarac Research Center

Recruiting

Tamarac, Florida, United States, 33321

Great Lakes Research Institute -Southfield

Recruiting

Southfield, Michigan, United States, 48075

REX Clinical Trials

Recruiting

Beaumont, Texas, United States, 77701

PanAmerican Clinical Research, LLC.

Recruiting

Brownsville, Texas, United States, 78520

South Ogden Family Medicine

Recruiting

South Ogden, Utah, United States, 84403

Clinical Research Partners

Recruiting

Richmond, Virginia, United States, 23226

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • mRNA-1283
  • mRNA-1283 vaccine
  • mRNA-1273
  • mRNA-1273 vaccine
  • SARS-CoV-2
  • SARS-CoV-2 Vaccine
  • Coronavirus
  • Virus Diseases
  • Messenger RNA
  • COVID-19
  • COVID-19 Vaccine
  • Moderna

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.