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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

NCT ID NCT07808697

NEW Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 11 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 viral infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BRCR Global

    San Juan, Puerto Rico, 00907, Puerto Rico

  • CEVAXIN 24 de Diciembre

    Panama City, Provincia de Panamá, Panama

  • CEVAXIN Avenida Mexico

    Calidonia, Provincia de Panamá, 7094, Panama

  • CEVAXIN Chorrera

    La Chorrera, Provincia de Panamá, Panama

  • Centro de Investigacion Clínica y Medicina Traslacional (CIMeT)

    Guadalajara, Jalisco, Mexico

  • Centro de Salud Tizimin

    Tizimín, Yucatán, Mexico

  • Childrens Hospital Regional Medical Center

    Seattle, Washington, 98105, United States

  • Clinical Research Partners

    Richmond, Virginia, 23226, United States

  • Eagle Clinical Research, LLC

    Chicago, Illinois, 60621, United States

  • Fundacion Respirar - Consultorios Medicos Dra De Salvo

    Ciudad Autonoma, Buenos Aires, Argentina

  • Great Lakes Research Institute -Southfield

    Southfield, Michigan, 48075, United States

  • Hope Research Network

    Miami, Florida, 33166, United States

  • Hospital General y de Especialidades Nuestra Señora de la Altagracia

    Salvaleón de Higüey, La Altagracia Province, Dominican Republic

  • Hospital Infantil de México Federico Gómez - Pediatric Gastroenterology

    Mexico City, Mexico City, Mexico

  • Hospital Materno Infantil San Lorenzo De Los Mina

    Santo Domingo, Nacional, 11901, Dominican Republic

  • Hospital del Nino Jesus

    San Miguel de Tucumán, Tucumán Province, Argentina

  • Indago Research and Health Cen

    Miami Lakes, Florida, 33016, United States

  • Instituto Dermatologico y Cirugia de Piel ''Dr. Huberto Bogaert Diaz'' (IDCP-DHBD)

    Santo Domingo, Distrito Nacional (Santo Domingo), 10306, Dominican Republic

  • Instituto Medico de la Fundacion Estudios Clinicos

    Casilda, Santa Fe Province, Argentina

  • Instituto Nacional de Pediatria

    Mexico City, Mexico City, Mexico

  • 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

  • Medvacplus Srl Fundacion Clinica Cruz Jiminian

    Cristo Rey, Distrito Nacional (Santo Domingo), 10501, Dominican Republic

  • MplusM - D&H Tamarac Research Center

    Tamarac, Florida, 33321, United States

  • Orange County Research Center

    Ontario, California, 91762, United States

  • PanAmerican Clinical Research - Queretaro

    Querétaro City, Querétaro, Mexico

  • PanAmerican Clinical Research, LLC.

    Brownsville, Texas, 78520, United States

  • Ponce Health Sciences University

    Ponce, Puerto Rico, Puerto Rico

  • REX Clinical Trials

    Beaumont, Texas, 77701, United States

  • Senders Pediatrics

    South Euclid, Ohio, 44121, United States

  • South Ogden Family Medicine

    South Ogden, Utah, 84403, United States

  • Spotlight Research Center - Internal Medicine

    Miami, Florida, 33167, United States

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