ClinicalTrials.gg
RecruitingNCT07808697Updated Nov 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.. Recruiting at 31 sites in 6 countries. Open to participants aged 6 Months to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 29, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓
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

In context

Coronavirus Infections

1,112 studies on the registry are indexed under Coronavirus Infections; 52 are open to participants now.

This study's planned enrollment of 300 is above the median of 120 across 655 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

ModernaTX, Inc. is the lead sponsor of 119 studies on the registry; 18 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 35 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

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 /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 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 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 ) prior to study intervention or plans to receive a nonstudy vaccine through 14 days after administration of study intervention.
  • Received systemic 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.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

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

06

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)

07

Study locations

12 of 31 sites recruiting
  • Orange County Research Center
    Ontario, California 91762, United States
    Recruiting
  • Hope Research Network
    Miami, Florida 33166, United States
    Recruiting
  • Spotlight Research Center - Internal Medicine
    Miami, Florida 33167, United States
    Recruiting
  • Indago Research and Health Cen
    Miami Lakes, Florida 33016, United States
    Recruiting
  • MplusM - D&H Tamarac Research Center
    Tamarac, Florida 33321, United States
    Recruiting
  • Eagle Clinical Research, LLC
    Chicago, Illinois 60621, United States
    Not yet recruiting
  • Great Lakes Research Institute -Southfield
    Southfield, Michigan 48075, United States
    Recruiting
  • Senders Pediatrics
    South Euclid, Ohio 44121, United States
    Not yet recruiting
  • REX Clinical Trials
    Beaumont, Texas 77701, United States
    Recruiting
  • PanAmerican Clinical Research, LLC.
    Brownsville, Texas 78520, United States
    Recruiting
  • South Ogden Family Medicine
    South Ogden, Utah 84403, United States
    Recruiting
  • Clinical Research Partners
    Richmond, Virginia 23226, United States
    Recruiting
  • Childrens Hospital Regional Medical Center
    Seattle, Washington 98105, 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) 10501, Dominican Republic
    Not yet recruiting
  • Instituto Dermatologico y Cirugia de Piel ''Dr. Huberto Bogaert Diaz'' (IDCP-DHBD)
    Santo Domingo, Distrito Nacional (Santo Domingo) 10306, 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 11901, 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, 7094, 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
  • Ponce Health Sciences University
    Ponce, Puerto Rico
    Recruiting
  • BRCR Global
    San Juan, 00907, Puerto Rico
    Recruiting
08

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 29, 2026
Sites
6 sites added, 6 sites removed. 25 sites changed recruiting status (15 now not yet recruiting, 10 now recruiting)
Show 25 sites
  • Orange County Research Center · Ontario, United Statesno status→Recruiting
  • Hope Research Network · Miami, United Statesno status→Recruiting
  • Spotlight Research Center - Internal Medicine · Miami, United Statesno status→Recruiting
  • Indago Research and Health Cen · Miami Lakes, United Statesno status→Recruiting
  • MplusM - D&H Tamarac Research Center · Tamarac, United Statesno status→Recruiting
  • Eagle Clinical Research, LLC · Chicago, United Statesno status→Not yet recruiting
  • Great Lakes Research Institute -Southfield · Southfield, United Statesno status→Recruiting
  • Senders Pediatrics · South Euclid, United Statesno status→Not yet recruiting
  • REX Clinical Trials · Beaumont, United Statesno status→Recruiting
  • PanAmerican Clinical Research, LLC. · Brownsville, United Statesno status→Recruiting
  • South Ogden Family Medicine · South Ogden, United Statesno status→Recruiting
  • Clinical Research Partners · Richmond, United Statesno status→Recruiting
  • Childrens Hospital Regional Medical Center · Seattle, United Statesno status→Not yet recruiting
  • Fundacion Respirar - Consultorios Medicos Dra De Salvo · Ciudad Autonoma, Argentinano status→Not yet recruiting
  • Instituto Medico de la Fundacion Estudios Clinicos · Casilda, Argentinano status→Not yet recruiting
  • Hospital del Nino Jesus · San Miguel de Tucumán, Argentinano status→Not yet recruiting
  • Medvacplus Srl Fundacion Clinica Cruz Jiminian · Cristo Rey, Dominican Republicno status→Not yet recruiting
  • Instituto Dermatologico y Cirugia de Piel ''Dr. Huberto Bogaert Diaz'' (IDCP-DHBD) · Santo Domingo, Dominican Republicno status→Not yet recruiting
  • Hospital General y de Especialidades Nuestra Señora de la Altagracia · Salvaleón de Higüey, Dominican Republicno status→Not yet recruiting
  • Hospital Materno Infantil San Lorenzo De Los Mina · Santo Domingo, Dominican Republicno status→Not yet recruiting
  • Centro de Investigacion Clínica y Medicina Traslacional (CIMeT) · Guadalajara, Mexicono status→Not yet recruiting
  • Hospital Infantil de México Federico Gómez - Pediatric Gastroenterology · Mexico City, Mexicono status→Not yet recruiting
  • Instituto Nacional de Pediatria · Mexico City, Mexicono status→Not yet recruiting
  • PanAmerican Clinical Research - Queretaro · Querétaro City, Mexicono status→Not yet recruiting
  • Centro de Salud Tizimin · Tizimín, Mexicono status→Not yet recruiting
Show 6 added (4 Panama, 2 Puerto Rico)
  • CEVAXIN Avenida Mexico · Caledonia, Panama
  • CEVAXIN Chorrera · La Chorrera, Panama
  • CEVAXIN 24 de Diciembre · Panama City, 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, Panama
  • Ponce Health Sciences University · Ponce, Puerto Rico
  • BRCR Global · San Juan, Puerto Rico
Show 6 removed
  • CEVAXIN Avenida Mexico · Calidonia, Panama
  • CEVAXIN Chorrera · La Chorrera, Panama
  • CEVAXIN 24 de Diciembre · Panama City, 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, Panama
  • Ponce Health Sciences University · Ponce, Puerto Rico
  • BRCR Global · San Juan, Puerto Rico
Oct 29, 2026
Start date
Sep 1, 2026→Sep 4, 2026 (actual)
Oct 29, 2026
Show all 2 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 29, 2026
    Not yet recruiting→Recruiting
    6 sites added, 6 sites removed. 25 sites changed recruiting status (15 now not yet recruiting, 10 now recruiting)
    Show 25 sites
    • Orange County Research Center · Ontario, United Statesno status→Recruiting
    • Hope Research Network · Miami, United Statesno status→Recruiting
    • Spotlight Research Center - Internal Medicine · Miami, United Statesno status→Recruiting
    • Indago Research and Health Cen · Miami Lakes, United Statesno status→Recruiting
    • MplusM - D&H Tamarac Research Center · Tamarac, United Statesno status→Recruiting
    • Eagle Clinical Research, LLC · Chicago, United Statesno status→Not yet recruiting
    • Great Lakes Research Institute -Southfield · Southfield, United Statesno status→Recruiting
    • Senders Pediatrics · South Euclid, United Statesno status→Not yet recruiting
    • REX Clinical Trials · Beaumont, United Statesno status→Recruiting
    • PanAmerican Clinical Research, LLC. · Brownsville, United Statesno status→Recruiting
    • South Ogden Family Medicine · South Ogden, United Statesno status→Recruiting
    • Clinical Research Partners · Richmond, United Statesno status→Recruiting
    • Childrens Hospital Regional Medical Center · Seattle, United Statesno status→Not yet recruiting
    • Fundacion Respirar - Consultorios Medicos Dra De Salvo · Ciudad Autonoma, Argentinano status→Not yet recruiting
    • Instituto Medico de la Fundacion Estudios Clinicos · Casilda, Argentinano status→Not yet recruiting
    • Hospital del Nino Jesus · San Miguel de Tucumán, Argentinano status→Not yet recruiting
    • Medvacplus Srl Fundacion Clinica Cruz Jiminian · Cristo Rey, Dominican Republicno status→Not yet recruiting
    • Instituto Dermatologico y Cirugia de Piel ''Dr. Huberto Bogaert Diaz'' (IDCP-DHBD) · Santo Domingo, Dominican Republicno status→Not yet recruiting
    • Hospital General y de Especialidades Nuestra Señora de la Altagracia · Salvaleón de Higüey, Dominican Republicno status→Not yet recruiting
    • Hospital Materno Infantil San Lorenzo De Los Mina · Santo Domingo, Dominican Republicno status→Not yet recruiting
    • Centro de Investigacion Clínica y Medicina Traslacional (CIMeT) · Guadalajara, Mexicono status→Not yet recruiting
    • Hospital Infantil de México Federico Gómez - Pediatric Gastroenterology · Mexico City, Mexicono status→Not yet recruiting
    • Instituto Nacional de Pediatria · Mexico City, Mexicono status→Not yet recruiting
    • PanAmerican Clinical Research - Queretaro · Querétaro City, Mexicono status→Not yet recruiting
    • Centro de Salud Tizimin · Tizimín, Mexicono status→Not yet recruiting
    Show 6 added (4 Panama, 2 Puerto Rico)
    • CEVAXIN Avenida Mexico · Caledonia, Panama
    • CEVAXIN Chorrera · La Chorrera, Panama
    • CEVAXIN 24 de Diciembre · Panama City, 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, Panama
    • Ponce Health Sciences University · Ponce, Puerto Rico
    • BRCR Global · San Juan, Puerto Rico
    Show 6 removed
    • CEVAXIN Avenida Mexico · Calidonia, Panama
    • CEVAXIN Chorrera · La Chorrera, Panama
    • CEVAXIN 24 de Diciembre · Panama City, 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, Panama
    • Ponce Health Sciences University · Ponce, Puerto Rico
    • BRCR Global · San Juan, Puerto Rico
    Start date Sep 1, 2026→Sep 4, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07808697
Lead sponsor
ModernaTX, Inc.
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Sep 4, 2026
Primary completion
Aug 30, 2029 (estimated)
Completion
Aug 30, 2029 (estimated)
Last update
Nov 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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Studies of the drug tested here: MRNA-1283

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