What this study is
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.
What's being tested
- mRNA-1283
Intervention · BIOLOGICAL
- mRNA-1273
Intervention · BIOLOGICAL
Both interventions
Sterile liquid for injection
Study details
- 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
- Sponsor
- ModernaTX, Inc.
- Conditions
- SARS-CoV-2
- Enrolling
- 300 people
- Starts
- 2026-09-04
- Est. completion
- 2029-08-30
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Months – 11 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (31)
31 openOrange County Research Center
Ontario, California, United States
RecruitingHope Research Network
Miami, Florida, United States
RecruitingSpotlight Research Center - Internal Medicine
Miami, Florida, United States
RecruitingIndago Research and Health Cen
Miami Lakes, Florida, United States
RecruitingMplusM - D&H Tamarac Research Center
Tamarac, Florida, United States
RecruitingEagle Clinical Research, LLC
Chicago, Illinois, United States
Not yet recruitingGreat Lakes Research Institute -Southfield
Southfield, Michigan, United States
RecruitingSenders Pediatrics
South Euclid, Ohio, United States
Not yet recruitingREX Clinical Trials
Beaumont, Texas, United States
RecruitingPanAmerican Clinical Research, LLC.
Brownsville, Texas, United States
RecruitingSouth Ogden Family Medicine
South Ogden, Utah, United States
RecruitingClinical Research Partners
Richmond, Virginia, United States
RecruitingChildrens Hospital Regional Medical Center
Seattle, Washington, United States
Not yet recruiting
18 sites outside the US
Fundacion Respirar - Consultorios Medicos Dra De Salvo
Ciudad Autonoma, Buenos Aires, Argentina
Not yet recruitingInstituto Medico de la Fundacion Estudios Clinicos
Casilda, Santa Fe Province, Argentina
Not yet recruitingHospital del Nino Jesus
San Miguel de Tucumán, Tucumán Province, Argentina
Not yet recruitingMedvacplus Srl Fundacion Clinica Cruz Jiminian
Cristo Rey, Distrito Nacional (Santo Domingo), Dominican Republic
Not yet recruitingInstituto Dermatologico y Cirugia de Piel ''Dr. Huberto Bogaert Diaz'' (IDCP-DHBD)
Santo Domingo, Distrito Nacional (Santo Domingo), Dominican Republic
Not yet recruitingHospital General y de Especialidades Nuestra Señora de la Altagracia
Salvaleón de Higüey, La Altagracia Province, Dominican Republic
Not yet recruitingHospital Materno Infantil San Lorenzo De Los Mina
Santo Domingo, Nacional, Dominican Republic
Not yet recruitingCentro de Investigacion Clínica y Medicina Traslacional (CIMeT)
Guadalajara, Jalisco, Mexico
Not yet recruitingHospital Infantil de México Federico Gómez - Pediatric Gastroenterology
Mexico City, Mexico City, Mexico
Not yet recruitingInstituto Nacional de Pediatria
Mexico City, Mexico City, Mexico
Not yet recruitingPanAmerican Clinical Research - Queretaro
Querétaro City, Querétaro, Mexico
Not yet recruitingCentro de Salud Tizimin
Tizimín, Yucatán, Mexico
Not yet recruitingCEVAXIN Avenida Mexico
Caledonia, Panama
Not yet recruitingCEVAXIN Chorrera
La Chorrera, Panama
Not yet recruitingCEVAXIN 24 de Diciembre
Panama City, Panama
Not yet recruitingInstituto 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 recruitingPonce Health Sciences University
Ponce, Puerto Rico
RecruitingBRCR Global
San Juan, Puerto Rico
Recruiting
Study team
Sponsor
ModernaTX, Inc.
Study ID mRNA-1283-P202
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.