Clinical trial Recruiting at 12 sites Phase 2 Interventional Ages 6 Months to 11

Vaccine study to test mRNA-1283 in children and infants

Official title: A Phase 2, Randomized, Observer-Blind, Dose Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age

Run by ModernaTX, Inc. · NCT07808697 · Data updated 2026-11-12

A vaccine study will test two dose levels of mRNA-1283 in kids from 6 months to under 12 years to see which dose works best, using mRNA-1273 as a comparison.

More SARS-CoV-2 trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages6 Months to 11 Years
SexAll
Enrollment300 (estimated)
SponsorModernaTX, Inc.
Industry-sponsored
Drugs / interventionsinfliximab, Nirsevimab, clesrovimab, prednisone
Locations31 sites (Ontario, California and 30 other locations)
StatusRecruiting
StartedSeptember 4, 2026
Main results expectedAugust 30, 2029
Study endsAugust 30, 2029
Registry record updatedNovember 9, 2026
Trial IDNCT07808697 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged ≥2 to <12 years (Cohort 1) or aged ≥6 months to <2 years (Cohort 2) in good health, with Cohort 2 limited to those born at ≥37 weeks and ≥2.5 kg at birth.

Probably not a fit

Some participants may not experience a measurable immune response or may encounter safety issues that preclude benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial compares two dose levels of mRNA-1283 to the established mRNA-1273 vaccine in pediatric participants. The study has two cohorts: Cohort 1 includes children aged 2 to under 12 years receiving a single dose, and Cohort 2 includes infants from 6 months to under 2 years receiving a two-dose series; prior COVID-19 vaccination status will be considered for Cohort 1. Participants will be monitored for safety, reactogenicity, and immune response to determine the optimal dose by age group. The lead sponsor is Moderna, with multiple clinical sites in California and Florida.

Why it matters

Potential benefit: If successful, the vaccine could provide a safe and effective option for protecting young children and infants against SARS-CoV-2.

How similar studies have gone: Earlier similar vaccine studies in children have shown the potential for immunogenicity with mRNA vaccines, though results vary by age and dose.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Orange County Research Center
    Ontario, California, United States
    Recruiting
  • Hope Research Network
    Miami, Florida, United States
    Recruiting
  • Spotlight Research Center - Internal Medicine
    Miami, Florida, United States
    Recruiting
  • Indago Research and Health Cen
    Miami Lakes, Florida, United States
    Recruiting
  • MplusM - D&H Tamarac Research Center
    Tamarac, Florida, United States
    Recruiting
  • Great Lakes Research Institute -Southfield
    Southfield, Michigan, United States
    Recruiting
Show 25 more locations
  • REX Clinical Trials
    Beaumont, Texas, United States
    Recruiting
  • PanAmerican Clinical Research, LLC.
    Brownsville, Texas, United States
    Recruiting
  • South Ogden Family Medicine
    South Ogden, Utah, United States
    Recruiting
  • Clinical Research Partners
    Richmond, Virginia, United States
    Recruiting
  • Ponce Health Sciences University
    Ponce, Puerto Rico
    Recruiting
  • BRCR Global
    San Juan, Puerto Rico
    Recruiting
  • Eagle Clinical Research, LLC
    Chicago, Illinois, United States
    Not yet recruiting
  • Senders Pediatrics
    South Euclid, Ohio, United States
    Not yet recruiting
  • Childrens Hospital Regional Medical Center
    Seattle, Washington, United States
    Not yet recruiting
  • Fundacion Respirar - Consultorios Medicos Dra De Salvo
    Ciudad Autonoma, Buenos Aires, Argentina
    Not yet recruiting
  • Instituto Medico de la Fundacion Estudios Clinicos
    Casilda, Santa Fe Province, Argentina
    Not yet recruiting
  • Hospital del Nino Jesus
    San Miguel de Tucumán, Tucumán Province, Argentina
    Not yet recruiting
  • Medvacplus Srl Fundacion Clinica Cruz Jiminian
    Cristo Rey, Distrito Nacional (Santo Domingo), Dominican Republic
    Not yet recruiting
  • Instituto Dermatologico y Cirugia de Piel ''Dr. Huberto Bogaert Diaz'' (IDCP-DHBD)
    Santo Domingo, Distrito Nacional (Santo Domingo), Dominican Republic
    Not yet recruiting
  • Hospital General y de Especialidades Nuestra Señora de la Altagracia
    Salvaleón de Higüey, La Altagracia Province, Dominican Republic
    Not yet recruiting
  • Hospital Materno Infantil San Lorenzo De Los Mina
    Santo Domingo, Nacional, Dominican Republic
    Not yet recruiting
  • Centro de Investigacion Clínica y Medicina Traslacional (CIMeT)
    Guadalajara, Jalisco, Mexico
    Not yet recruiting
  • Hospital Infantil de México Federico Gómez - Pediatric Gastroenterology
    Mexico City, Mexico City, Mexico
    Not yet recruiting
  • Instituto Nacional de Pediatria
    Mexico City, Mexico City, Mexico
    Not yet recruiting
  • PanAmerican Clinical Research - Queretaro
    Querétaro City, Querétaro, Mexico
    Not yet recruiting
  • Centro de Salud Tizimin
    Tizimín, Yucatán, Mexico
    Not yet recruiting
  • CEVAXIN Avenida Mexico
    Caledonia, Panama
    Not yet recruiting
  • CEVAXIN Chorrera
    La Chorrera, Panama
    Not yet recruiting
  • CEVAXIN 24 de Diciembre
    Panama City, Panama
    Not yet recruiting
  • 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, Panama
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.