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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

2026年9月2日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

300

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Ontario、California、アメリカ、91762
        • Orange County Research Center
    • Florida
      • Miami、Florida、アメリカ、33166
        • Hope Research Network
      • Miami、Florida、アメリカ、33167
        • Spotlight Research Center - Internal Medicine
      • Miami Lakes、Florida、アメリカ、33016
        • Indago Research and Health Cen
      • Tamarac、Florida、アメリカ、33321
        • MplusM - D&H Tamarac Research Center
    • Illinois
      • Chicago、Illinois、アメリカ、60621
        • Eagle Clinical Research, LLC
    • Michigan
      • Southfield、Michigan、アメリカ、48075
        • Great Lakes Research Institute -Southfield
    • Ohio
      • South Euclid、Ohio、アメリカ、44121
        • Senders Pediatrics
    • Texas
      • Beaumont、Texas、アメリカ、77701
        • REX Clinical Trials
      • Brownsville、Texas、アメリカ、78520
        • PanAmerican Clinical Research, LLC.
    • Utah
      • South Ogden、Utah、アメリカ、84403
        • South Ogden Family Medicine
    • Virginia
      • Richmond、Virginia、アメリカ、23226
        • Clinical Research Partners
    • Washington
      • Seattle、Washington、アメリカ、98105
        • Childrens Hospital Regional Medical Center
  • アルゼンチン
    • Buenos Aires
      • Ciudad Autonoma、Buenos Aires、アルゼンチン
        • Fundacion Respirar - Consultorios Medicos Dra De Salvo
    • Santa Fe Province
      • Casilda、Santa Fe Province、アルゼンチン
        • Instituto Medico de la Fundacion Estudios Clinicos
    • Tucumán Province
      • San Miguel de Tucumán、Tucumán Province、アルゼンチン
        • Hospital del Nino Jesus
  • ドミニカ共和国
    • Distrito Nacional (Santo Domingo)
      • Cristo Rey、Distrito Nacional (Santo Domingo)、ドミニカ共和国、10501
        • Medvacplus Srl Fundacion Clinica Cruz Jiminian
      • Santo Domingo、Distrito Nacional (Santo Domingo)、ドミニカ共和国、10306
        • Instituto Dermatologico y Cirugia de Piel ''Dr. Huberto Bogaert Diaz'' (IDCP-DHBD)
    • La Altagracia Province
      • Salvaleón de Higüey、La Altagracia Province、ドミニカ共和国
        • Hospital General y de Especialidades Nuestra Señora de la Altagracia
    • Nacional
      • Santo Domingo、Nacional、ドミニカ共和国、11901
        • Hospital Materno Infantil San Lorenzo De Los Mina
  • パナマ
    • Provincia de Panamá
      • Calidonia、Provincia de Panamá、パナマ、7094
        • CEVAXIN Avenida Mexico
      • La Chorrera、Provincia de Panamá、パナマ
        • CEVAXIN Chorrera
      • Panama City、Provincia de Panamá、パナマ
        • CEVAXIN 24 de Diciembre
      • Panama City、Provincia de Panamá、パナマ
        • 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
  • プエルトリコ
    • Puerto Rico
      • Ponce、Puerto Rico、プエルトリコ
        • Ponce Health Sciences University
      • San Juan、Puerto Rico、プエルトリコ、00907
        • BRCR Global
  • メキシコ
    • Jalisco
      • Guadalajara、Jalisco、メキシコ
        • Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)
    • Mexico City
      • Mexico City、Mexico City、メキシコ
        • Hospital Infantil de México Federico Gómez - Pediatric Gastroenterology
      • Mexico City、Mexico City、メキシコ
        • Instituto Nacional de Pediatría
    • Querétaro
      • Querétaro City、Querétaro、メキシコ
        • PanAmerican Clinical Research - Queretaro
    • Yucatán
      • Tizimín、Yucatán、メキシコ
        • Centro de Salud Tizimin

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Cohort 1: mRNA-1283 Dose Level 1
Participants aged 2 to <12 years receive one IM dose of on Day 1.
生物学的：mRNA-1283
注射用滅菌液
実験的：Cohort 1: mRNA-1283 Dose Level 2
Participants aged 2 to <12 years receive one IM dose of on Day 1.
生物学的：mRNA-1283
注射用滅菌液
アクティブコンパレータ：Cohort 1: mRNA-1273
Participants aged 2 to <12 years receive one IM dose of on Day 1.
生物学的：mRNA-1273
注射用滅菌液
実験的：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).
生物学的：mRNA-1283
注射用滅菌液
実験的：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).
生物学的：mRNA-1283
注射用滅菌液
アクティブコンパレータ：Cohort 2: mRNA-1273
Participants aged 6 months to <2 years receive two IM doses 28 days apart (Day 1 and 29).
生物学的：mRNA-1273
注射用滅菌液

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 29 (Cohort 1), Day 57 (Cohort 2)
Day 29 (Cohort 1), Day 57 (Cohort 2)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

ModernaTX, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2029年8月30日

研究の完了 (推定)

2029年8月30日

試験登録日

最初に提出

2026年9月2日

QC基準を満たした最初の提出物

2026年9月2日

最初の投稿 (実際)

2026年9月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月9日

QC基準を満たした最後の更新が送信されました

2026年9月2日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • mRNA-1283-P202

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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