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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. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

300

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cohort 1: mRNA-1283 Dose Level 1
Participants aged 2 to <12 years receive one IM dose of on Day 1.
Biologisch: mRNA-1283
Sterile Flüssigkeit zur Injektion
Experimental: Cohort 1: mRNA-1283 Dose Level 2
Participants aged 2 to <12 years receive one IM dose of on Day 1.
Biologisch: mRNA-1283
Sterile Flüssigkeit zur Injektion
Aktiver Komparator: Cohort 1: mRNA-1273
Participants aged 2 to <12 years receive one IM dose of on Day 1.
Biologisch: mRNA-1273
Sterile Flüssigkeit zur Injektion
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).
Biologisch: mRNA-1283
Sterile Flüssigkeit zur Injektion
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).
Biologisch: mRNA-1283
Sterile Flüssigkeit zur Injektion
Aktiver Komparator: Cohort 2: mRNA-1273
Participants aged 6 months to <2 years receive two IM doses 28 days apart (Day 1 and 29).
Biologisch: mRNA-1273
Sterile Flüssigkeit zur Injektion

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 29 (Cohort 1), Day 57 (Cohort 2)
Day 29 (Cohort 1), Day 57 (Cohort 2)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

ModernaTX, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

30. August 2029

Studienabschluss (Geschätzt)

30. August 2029

Studienanmeldedaten

Zuerst eingereicht

2. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. September 2026

Zuerst gepostet (Tatsächlich)

9. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • mRNA-1283-P202

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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