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Not yet recruitingNCT07808697Updated Sep 9, 2026

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age

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

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
6 Months to 11 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • SARS-CoV-2

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
03

Who can participate

Ages eligible
6 Months to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Cohort 1: mRNA-1283 Dose Level 1

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

    Biological: mRNA-1283

  • Experimental
    Cohort 1: mRNA-1283 Dose Level 2

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

    Biological: mRNA-1283

  • Active comparator
    Cohort 1: mRNA-1273

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

    Biological: mRNA-1273

  • 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).

    Biological: mRNA-1283

  • 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).

    Biological: mRNA-1283

  • Active comparator
    Cohort 2: mRNA-1273

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

    Biological: mRNA-1273

Interventions

  • BiologicalmRNA-1283

    Sterile liquid for injection

  • BiologicalmRNA-1273

    Sterile liquid for injection

05

What researchers measure

Primary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Cohort 1 and Cohort 2: Number of Participants with Seroresponse Rate

    Time frame: Day 29 (Cohort 1), Day 57 (Cohort 2)

06

Study locations

31 sites
  • Orange County Research Center
    Ontario, California 91762, United States
  • Hope Research Network
    Miami, Florida 33166, United States
  • Spotlight Research Center - Internal Medicine
    Miami, Florida 33167, United States
  • Indago Research and Health Cen
    Miami Lakes, Florida 33016, United States
  • MplusM - D&H Tamarac Research Center
    Tamarac, Florida 33321, United States
  • Eagle Clinical Research, LLC
    Chicago, Illinois 60621, United States
  • Great Lakes Research Institute -Southfield
    Southfield, Michigan 48075, United States
  • Senders Pediatrics
    South Euclid, Ohio 44121, United States
  • REX Clinical Trials
    Beaumont, Texas 77701, United States
  • PanAmerican Clinical Research, LLC.
    Brownsville, Texas 78520, United States
  • South Ogden Family Medicine
    South Ogden, Utah 84403, United States
  • Clinical Research Partners
    Richmond, Virginia 23226, United States
  • Childrens Hospital Regional Medical Center
    Seattle, Washington 98105, United States
  • Fundacion Respirar - Consultorios Medicos Dra De Salvo
    Ciudad Autonoma, Buenos Aires, Argentina
  • Instituto Medico de la Fundacion Estudios Clinicos
    Casilda, Santa Fe Province, Argentina
  • Hospital del Nino Jesus
    San Miguel de Tucumán, Tucumán Province, Argentina
  • Medvacplus Srl Fundacion Clinica Cruz Jiminian
    Cristo Rey, Distrito Nacional (Santo Domingo) 10501, Dominican Republic
  • Instituto Dermatologico y Cirugia de Piel ''Dr. Huberto Bogaert Diaz'' (IDCP-DHBD)
    Santo Domingo, Distrito Nacional (Santo Domingo) 10306, Dominican Republic
  • Hospital General y de Especialidades Nuestra Señora de la Altagracia
    Salvaleón de Higüey, La Altagracia Province, Dominican Republic
  • Hospital Materno Infantil San Lorenzo De Los Mina
    Santo Domingo, Nacional 11901, Dominican Republic
  • Centro de Investigacion Clínica y Medicina Traslacional (CIMeT)
    Guadalajara, Jalisco, Mexico
  • Hospital Infantil de México Federico Gómez - Pediatric Gastroenterology
    Mexico City, Mexico City, Mexico
  • Instituto Nacional de Pediatria
    Mexico City, Mexico City, Mexico
  • PanAmerican Clinical Research - Queretaro
    Querétaro City, Querétaro, Mexico
  • Centro de Salud Tizimin
    Tizimín, Yucatán, Mexico
  • CEVAXIN Avenida Mexico
    Calidonia, Provincia de Panamá 7094, Panama
  • CEVAXIN Chorrera
    La Chorrera, Provincia de Panamá, Panama
  • CEVAXIN 24 de Diciembre
    Panama City, Provincia de Panamá, Panama
  • Instituto de Investigaciones Cienti-ficas Y Servicios de Alta Tecnologia Asociacion de Interes Panama; . Centro de Investigación, Innovación y Gestión del Conocimiento de Ciudad de la Salud, Caja de Seguro social
    Panama City, Provincia de Panamá, Panama
  • Ponce Health Sciences University
    Ponce, Puerto Rico, Puerto Rico
  • BRCR Global
    San Juan, Puerto Rico 00907, Puerto Rico
07

Registry details

Key details

Study ID
NCT07808697
Lead sponsor
ModernaTX, Inc.
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Aug 30, 2029 (estimated)
Completion
Aug 30, 2029 (estimated)
Last update
Sep 9, 2026

Study contacts

Moderna WeCare Team
Contact
WeCareClinicalTrials@modernatx.com
1-866-663-3762

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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