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

2 septembre 2026 mis à jour par: ModernaTX, Inc.

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

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

300

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cohort 1: mRNA-1283 Dose Level 1
Participants aged 2 to <12 years receive one IM dose of on Day 1.
Biologique: ARNm-1283
Liquide stérile pour injection
Expérimental: Cohort 1: mRNA-1283 Dose Level 2
Participants aged 2 to <12 years receive one IM dose of on Day 1.
Biologique: ARNm-1283
Liquide stérile pour injection
Comparateur actif: Cohort 1: mRNA-1273
Participants aged 2 to <12 years receive one IM dose of on Day 1.
Biologique: ARNm-1273
Liquide stérile pour injection
Expérimental: 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).
Biologique: ARNm-1283
Liquide stérile pour injection
Expérimental: 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).
Biologique: ARNm-1283
Liquide stérile pour injection
Comparateur actif: Cohort 2: mRNA-1273
Participants aged 6 months to <2 years receive two IM doses 28 days apart (Day 1 and 29).
Biologique: ARNm-1273
Liquide stérile pour injection

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Délai: Day 1 through Day 7; 7 Days following injection
Day 1 through Day 7; 7 Days following injection
Cohort 1 and Cohort 2: Number of Participants with Unsolicited Adverse Events (AEs)
Délai: Day 1 through Day 28 (Cohort 1); 28 Days following injection (Cohort 2)
Day 1 through Day 28 (Cohort 1); 28 Days following injection (Cohort 2)
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
Délai: Day 1 through End of Study (Month 13)
Day 1 through End of Study (Month 13)
Cohort 1 and Cohort 2: Geometric Mean Value of Antibody Level Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Target Variant
Délai: Day 29 VISIT (Cohort 1), Day 57 VISIT (Cohort 2)
Day 29 VISIT (Cohort 1), Day 57 VISIT (Cohort 2)
Cohort 1 and Cohort 2: Geometric Mean Fold Rise of Antibody Level Against SARS-CoV-2
Délai: Day 29 (Cohort 1), Day 57 (Cohort 2)
Day 29 (Cohort 1), Day 57 (Cohort 2)
Cohort 1 and Cohort 2: Number of Participants with Seroresponse Rate
Délai: Day 29 (Cohort 1), Day 57 (Cohort 2)
Day 29 (Cohort 1), Day 57 (Cohort 2)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

ModernaTX, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

30 août 2029

Achèvement de l'étude (Estimé)

30 août 2029

Dates d'inscription aux études

Première soumission

2 septembre 2026

Première soumission répondant aux critères de contrôle qualité

2 septembre 2026

Première publication (Réel)

9 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • mRNA-1283-P202

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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