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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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

300

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort 1: mRNA-1283 Dose Level 1
Participants aged 2 to <12 years receive one IM dose of on Day 1.
生物：mRNA-1283
无菌注射液
实验性的：Cohort 1: mRNA-1283 Dose Level 2
Participants aged 2 to <12 years receive one IM dose of on Day 1.
生物：mRNA-1283
无菌注射液
有源比较器：Cohort 1: mRNA-1273
Participants aged 2 to <12 years receive one IM dose of on Day 1.
生物：mRNA-1273
无菌注射液
实验性的：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：mRNA-1283
无菌注射液
实验性的：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：mRNA-1283
无菌注射液
有源比较器：Cohort 2: mRNA-1273
Participants aged 6 months to <2 years receive two IM doses 28 days apart (Day 1 and 29).
生物：mRNA-1273
无菌注射液

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Day 29 (Cohort 1), Day 57 (Cohort 2)
Day 29 (Cohort 1), Day 57 (Cohort 2)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ModernaTX, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2029年8月30日

研究完成 (估计的)

2029年8月30日

研究注册日期

首次提交

2026年9月2日

首先提交符合 QC 标准的

2026年9月2日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • mRNA-1283-P202

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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