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MRNA-1345（一种针对呼吸道合胞病毒的 mRNA 疫苗）在 2 至 2 岁儿童中的研究

2026年7月27日 更新者：ModernaTX, Inc.

一项 2 期随机、观察者盲法研究，旨在评估 mRNA-1345（一种针对呼吸道合胞病毒的 mRNA 疫苗）在 2 至 2 岁儿童中的安全性、反应原性和免疫原性

该研究的目的是评估 mRNA-1345 在 2 至 5 岁以下儿童以及 5 至 18 岁以下呼吸道合胞病毒 (RSV) 疾病高危儿童中的安全性、反应原性和免疫原性为下一阶段的开发（第 3 阶段）的剂量水平选择提供信息。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

349

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。

学习地点

  • 巴拿马
      • La Chorrera、巴拿马、07066
        • CEVAXIN Chorrera
      • Panama City、巴拿马、07093
        • CEVAXIN Avenida Mexico
      • Panama City、巴拿马、07114
        • CEVAXIN 24 de Diciembre
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85006
        • Velocity Clinical Research, Phoenix
      • Scottsdale、Arizona、美国、85260
        • Headlands Research - Scottsdale
    • California
      • Banning、California、美国、92220
        • Velocity Clinical Research - Banning
      • Fullerton、California、美国、92835
        • ASCADA Research, LLC - Family Medicine
      • Long Beach、California、美国、90815
        • ARK Clinical Research
      • Rolling Hills Estates、California、美国、90274
        • Peninsula Research Associates (PRA)
    • Florida
      • Doral、Florida、美国、33122
        • D&H Doral Research Center, LLC
      • Kissimmee、Florida、美国、34741
        • Kissimmee Clinical Research
      • Largo、Florida、美国、33777
        • Accel Clinical
      • Miami、Florida、美国、33125
        • Med-Care Research
      • Orlando、Florida、美国、32829
        • Accel Research Sites - Nona Pediatric Center
      • Pensacola、Florida、美国、32501
        • Sec Clinical Research
      • Tamarac、Florida、美国、33321
        • D&H Tamarac Research Center
    • Georgia
      • Fayetteville、Georgia、美国、30214
        • Javara, Inc.
      • Macon、Georgia、美国、31210
        • Velocity Clinical Research-Primary Pediatrics, Macon
      • Savannah、Georgia、美国、31405
        • CenExel iResearch, LLC
    • Idaho
      • Idaho Falls、Idaho、美国、83404
        • Clinical Research Prime
      • Meridian、Idaho、美国、83642
        • Velocity Clinical Research - Boise
    • Kansas
      • El Dorado、Kansas、美国、67042
        • Alliance for Multispeciality Research, LLC
      • Overland Park、Kansas、美国、66210
        • Velocity Clinical Research-Kansas City
    • Louisiana
      • Lafayette、Louisiana、美国、70508
        • Velocity Clinical Research - Lafayette
      • Metairie、Louisiana、美国、70006
        • Velocity Clinical Research Metairie
    • Michigan
      • Southfield、Michigan、美国、48075
        • Great Lakes Research Institute
      • Southgate、Michigan、美国、48195-1896
        • Pediatric & Adolescent Center
    • Minnesota
      • Minneapolis、Minnesota、美国、55402
        • Clinical Research Institute
    • Mississippi
      • Gulfport、Mississippi、美国、39503
        • Velocity Clinical Research, Gulfport
    • New Mexico
      • Albuquerque、New Mexico、美国、87107
        • Velocity Clinical Research- Albuquerque
    • New York
      • Binghamton、New York、美国、13905
        • Velocity Clinical Research-Binghamton
      • Rochester、New York、美国、14620
        • University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
    • Ohio
      • South Euclid、Ohio、美国、44121
        • Senders Pediatrics
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • DM Clinical Research - Philadelphia
      • Philadelphia、Pennsylvania、美国、19104-4318
        • The Children's Hospital of Philadelphia - Pediatrics
    • Rhode Island
      • Providence、Rhode Island、美国、02886
        • Velocity Clinical Research - Providence
    • South Carolina
      • Charleston、South Carolina、美国、29414
        • Coastal Pediatric Research
      • Simpsonville、South Carolina、美国、29680
        • TRIBE Clinical Research
    • Texas
      • Austin、Texas、美国、78704
        • Elligo Clinical Research Center
      • Beaumont、Texas、美国、77701
        • REX Clinical Trials, LLC
      • Conroe、Texas、美国、77384
        • Javara Inc (Conroe)
      • Houston、Texas、美国、77055
        • West Houston Clinical Research Service
      • Houston、Texas、美国、77065
        • DM Clinical Research - CyFair
      • Plano、Texas、美国、75024
        • Village Pediatrics
      • Stephenville、Texas、美国、76401
        • Javara Inc/Texas Health Care, PLLC d/b/a/ Privia Medical Group-North Texas
      • Victoria、Texas、美国、77901
        • Victoria Clinical Research Group
    • Utah
      • West Jordan、Utah、美国、84088
        • Velocity Clinical Research - Salt Lake City
    • Virginia
      • Annandale、Virginia、美国、22003
        • PI-Coor Clinical Research, LLC
      • Richmond、Virginia、美国、23294
        • National Clinical Research, Inc.
      • Richmond、Virginia、美国、23226
        • Clinical Research Partners

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

主要纳入标准：

第 1 组：

  • 签署知情同意书时年龄为 2 至 <5 岁。
  • 根据研究者的临床判断，健康或患有稳定的慢性病会增加 RSV 疾病的风险。

第 2 组：

  • 签署知情同意书时年龄为 5 至 <18 岁。
  • 患有稳定慢性病的参与者会增加患 RSV 疾病的风险。
  • 有生育能力的女性参与者可以参加该研究，如果参与者： 1) 在筛选时和注射当天（第 1 天）尿液妊娠测试呈阴性； 2) 在第一天之前的 28 天内采取了充分的避孕措施或避免了所有可能导致怀孕的活动； 3) 同意在注射后 90 天内继续充分避孕； 4) 目前未进行母乳喂养。

主要排除标准：

  • 重病或发烧（体温≥38.0°C [100.4°Fahrenheit]） 在筛选访视或第一天之前或之时 72 小时内。
  • 根据研究者的判断，可能影响研究评估或危及参与者安全的诊断或病症史。
  • 在研究疫苗注射前 14 天（第 1 天）内已​​接受或计划接受任何许可或授权的疫苗，或计划在研究疫苗注射后 14 天内接受许可或授权的疫苗。
  • 之前接受过任何全身性免疫抑制剂或免疫调节药物。 如果在入组前至少 3 个月完成，则允许短期（<7 天）口服皮质类固醇课程。
  • 在参加研究前 6 个月内收到 RSV 单克隆抗体。
  • 在入组日前 28 天内（对于评估该年龄组未获得许可的产品的研究为 6 个月）参加过介入性临床研究，或计划在入组本研究时参与。

注意：其他协议定义的纳入和排除标准可能适用。

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：A 部分和 B 部分：第 1 组（2 至 <5 岁）
A 部分：2 岁至 5 岁以下的参与者将在第一天接受单次肌内 (IM) 注射 mRNA-1345 或安慰剂。B 部分：参与者可以选择重新加入 6 个月的安全期- 随访期。
生物：安慰剂
0.9%氯化钠（生理盐水）注射液
生物：mRNA-1345
无菌注射液
实验性的：A 部分：第 2 组（5 至 18 岁以下）
5 岁至 18 岁以下的参与者将在第一天接受单次 mRNA-1345 的肌内注射。
生物：mRNA-1345
无菌注射液

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Part A (Cohorts 1 and 2): Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
大体时间：Up to 7 days post-injection
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to 7 days post-injection
Part A (Cohorts 1 and 2): Number of Participants With Unsolicited Adverse Events (AEs)
大体时间：Up to 28 days post-injection
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to 28 days post-injection
Part A (Cohorts 1 and 2): Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
大体时间：Day 1 through end of Part A (Month 6)
A MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through end of Part A (Month 6)
Part B (Cohort 1): Number of Participants With RSV-RTD, Respiratory Syncytial Virus- Lower Respiratory Tract Disease (RSV-LRTD), Severe RSV-LRTD, Very Severe RSV-LRTD and RSV Hospitalization Classified by Clinical Assessment Team (CAT)
大体时间：Day 1 through end of Part B (Month 6)
RSV-RTD: Runny nose or blocked nose or cough and confirmed RSV infection. RSV-LRTD: Cough or difficulty breathing (Based on Investigator's observation; difficulty breathing included signs of wheezing, stridor, tachypnoea, chest in-drawing or subcostal or intercostal retractions) and peripheral oxygen saturation (SpO2) <95%, or respiratory rate (RR) increased and confirmed RSV infection. RSV Severe-LRTD: Meeting the definition of RSV-LRTD and SpO2 <93%, or lower chest wall in-drawing. RSV Very Severe LRTD: Meeting the definition of RSV-LRTD and SpO2 <90%, or failure to respond/unconscious. RSV Hospitalization: Confirmed RSV and hospitalized for acute medical condition.
Day 1 through end of Part B (Month 6)

次要结果测量

结果测量
措施说明
大体时间
Part A (Cohort 1): Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody
大体时间：Day 1, Day 29, and Month 6
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) for RSV-A and 10 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 112476 IU/mL for RSV-B. 95% confidence interval (CI) for geometric mean (GM) value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1, Day 29, and Month 6
Part A (Cohort 1): Geometric Mean Concentration (GMC) of Serum RSV Prefusion F (Pre-F) Binding Antibody
大体时间：Day 1, Day 29, and Month 6
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 arbitrary units (AU)/mL and ULOQ was 580553 AU/mL for RSV Pre-F immunoglobulin G (IgG) antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1, Day 29, and Month 6
Part A (Cohort 1): Geometric Mean Fold Rise (GMFR) of Post-baseline/Baseline Neutralizing Antibody Titers
大体时间：Day 29 and Month 6
Antibody values reported as below lower LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL for RSV-A and 10 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 112476 IU/mL for RSV-B. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29 and Month 6
Part A (Cohort 1): GMFR of Post-baseline/Baseline Binding Antibody Concentrations
大体时间：Day 29 and Month 6
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 AU/mL and ULOQ was 580553 AU/mL for RSV Pre-F IgG antibody. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29 and Month 6
Part A (Cohort 1): Percentage of Participants With Seroresponse in RSV Neutralizing Antibody
大体时间：Baseline to Day 29 and Month 6
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29 and Month 6
Part A (Cohort 1): Percentage of Participants With Seroresponse in RSV Pre-F Binding Antibody
大体时间：Baseline to Day 29 and Month 6
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29 and Month 6
Part A (Cohort 2): GMT of Serum RSV Neutralizing Antibody
大体时间：Day 1 and Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL for RSV-A and 15 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 162163 IU/mL for RSV-B. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1 and Day 29
Part A (Cohort 2): GMC of Serum RSV Pre-F Binding Antibody
大体时间：Day 1 and Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 AU/mL and ULOQ was 580553 AU/mL for RSV Pre-F IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1 and Day 29
Part A (Cohort 2): GMFR of Post-baseline/Baseline Neutralizing Antibody Titers
大体时间：Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL for RSV-A and 15 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 162163 IU/mL for RSV-B. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29
Part A (Cohort 2): GMFR of Post-baseline/Baseline Binding Antibody Concentrations
大体时间：Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 AU/mL and ULOQ was 580553 AU/mL for RSV Pre-F IgG antibody. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29
Part A (Cohort 2): Percentage of Participants With Seroresponse in RSV Neutralizing Antibody
大体时间：Baseline to Day 29
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29
Part A (Cohort 2): Percentage of Participants With Seroresponse in RSV Pre-F Binding Antibody
大体时间：Baseline to Day 29
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29
Part B (Cohort 1): Number of Participants With AESIs and SAEs
大体时间：Day 1 through Part B EOS (Month 6)
An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through Part B EOS (Month 6)

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 (实际的)

2023年10月24日

初级完成 (实际的)

2025年6月27日

研究完成 (实际的)

2025年6月27日

研究注册日期

首次提交

2023年10月18日

首先提交符合 QC 标准的

2023年10月18日

首次发布 (实际的)

2023年10月24日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年7月27日

最后验证

2026年7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-1345-P202
  • 2024-000502-15 (EudraCT编号)

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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