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四价流感 mRNA 疫苗对 18 岁及以上成人的安全性和免疫原性研究

2026年7月9日 更新者：Sanofi Pasteur, a Sanofi Company

一项 I/II 期研究，旨在调查四价流感 mRNA 疫苗 MRT5421、MRT5424 和 MRT5429 在 18 岁及以上健康参与者中的安全性和免疫原性

本研究的目的是评估单次肌内 (IM) 注射四价流感疫苗 (QIV) 信使核糖核酸 (mRNA)（MRT5421、MRT5424 和 MRT5429）的不同配方与活性对照（ QIV- 标准剂量 (SD)、QIV- 高剂量 (HD) [仅限 ≥ 65 岁的成人] 或四价重组流感疫苗 (RIV4)）用于 18 岁及以上成人。

研究概览

地位

完全的

条件

干预/治疗

详细说明

每个参与者的研究持续时间约为 12 个月。

  • 治疗持续时间：注射 1 次 7 种 QIV mRNA 之一或对照之一
  • 顺序入组的剂量递增

研究类型

介入性

注册 (实际的)

908

阶段

  • 阶段2
  • 阶段1

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

  • 波多黎各
      • Barrio Sabana、波多黎各、00694
        • Investigational Site Number : 6300002
  • 洪都拉斯
      • San Pedro Sula、洪都拉斯、21104
        • Investigational Site Number : 3400001
  • 美国
    • California
      • San Diego、California、美国、92123-1881
        • California Research Foundation Site Number : 8400038
    • Florida
      • Hialeah、Florida、美国、33012
        • Indago Research and Health Center- Site Number : 8400032
      • Hollywood、Florida、美国、33024
        • Cenexel Research Centers of America- Site Number : 8400037
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • Brengle Family Medicine Site Number : 8400045
    • Kentucky
      • Lexington、Kentucky、美国、40509
        • AMR Lexington- Site Number : 8400042
    • Louisiana
      • New Orleans、Louisiana、美国、70119
        • Velocity Clinical Research- New Orleans Site Number : 8400053
    • Missouri
      • Kansas City、Missouri、美国、64114
        • The Alliance for Multispecialty Research - KCM, LLC- Site Number : 8400034
    • Nebraska
      • Norfolk、Nebraska、美国、68701
        • Velocity Clinical Research Norfolk- Site Number : 8400046
    • Tennessee
      • Knoxville、Tennessee、美国、37909
        • AMR Knoxville- Site Number : 8400043
    • Texas
      • San Antonio、Texas、美国、78229
        • Clinical Trials of Texas, Inc. - PPDS- Site Number : 8400029
    • Utah
      • Salt Lake City、Utah、美国、84107
        • Cenexel JBR- Site Number : 8400051

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

  • 成人
  • 年长者

接受健康志愿者

是的

描述

入选标准： - 入选之日年满 18 岁或入选之日年满 21 岁，具体取决于国家/地区。

  • 女性参与者如果未怀孕或未哺乳且符合以下条件之一，则有资格参加：

    • 具有非生育潜力。 要被视为具有非生育潜力，女性必须绝经至少一年，或接受手术绝育，或
    • 具有生育能力，并同意在研究干预前至少 4 周至研究干预后至少 12 周内使用有效的避孕方法或禁欲。
  • 有生育能力的女性参与者必须在第一次研究干预前 8 小时内进行高敏感妊娠测试（根据当地法规要求的尿液或血清）呈阴性排除标准：如果适用以下任何标准，则参与者被排除在研究之外:
  • 已知或疑似先天性或后天性免疫缺陷；或在过去6个月内接受过免疫抑制治疗，例如抗癌化疗或放射治疗；或长期全身性皮质类固醇治疗（过去3个月内连续2周以上泼尼松或同等药物）
  • 已知对任何研究干预成分（例如聚乙二醇、聚山梨酯）存在全身过敏；对研究中使用的研究干预措施或含有任何相同物质的产品有危及生命的反应史；注射 mRNA 疫苗后出现任何过敏反应（例如过敏反应）
  • 既往有心肌炎、心包炎和/或心肌心包炎病史
  • 既往有吉莲-巴利综合征 (GBS)、神经炎（包括贝尔麻痹）、惊厥、脑炎、横贯性脊髓炎和血管炎的已知病史
  • 心电图符合可能的心肌炎或心包炎的参与者，或者研究者认为，表现出可能影响参与者安全或研究结果的临床相关异常
  • 自我报告的血小板减少症，根据研究者的判断禁忌肌内疫苗接种
  • 出血性疾病，或入组前 3 周内接受过抗凝剂，根据研究者的判断，禁忌肌内疫苗接种
  • 研究者认为慢性疾病处于可能干扰研究进行或完成的阶段
  • 接种当天患有中度或严重急性疾病/感染（根据研究者的判断）或发热性疾病（体温≥ 38.0°C [≥ 100.4°F]）。 在病情解决或发热事件消退之前，不应将潜在参与者纳入研究
  • 第一次就诊前 10 天内出现急性感染症状或 SARS-CoV-2 RT-PCR 或抗原检测呈阳性的参与者 (V01)
  • 在研究干预给药前 4 周内接受任何疫苗或计划在研究干预给药后 4 周内接受任何疫苗
  • 过去 3 个月内接受过免疫球蛋白、血液或血液衍生产品
  • 过去 6 个月内曾使用研究或上市疫苗接种过流感疫苗
  • 在研究干预实施前 2 个月内收到任何 mRNA 疫苗/产品 注意：上述信息并不旨在包含与患者潜在参与临床试验相关的所有考虑因素。

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：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Quadrivalent Influenza mRNA Vaccine MRT5421 Dose 1
participants received a single dose of QIV mRNA vaccine MRT5421
生物：四价流感 mRNA 疫苗 MRT5421
剂型：小瓶溶液给药途径：肌肉注射
实验性的：Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1
participants received a single dose of QIV mRNA vaccine MRT5429
生物：四价流感 mRNA 疫苗 MRT5429
剂型：小瓶溶液-给药途径：肌肉注射
实验性的：Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 2
participants received a single dose of QIV mRNA vaccine MRT5429
生物：四价流感 mRNA 疫苗 MRT5429
剂型：小瓶溶液-给药途径：肌肉注射
实验性的：Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 3
participants received a single dose of QIV mRNA vaccine MRT5429
生物：四价流感 mRNA 疫苗 MRT5429
剂型：小瓶溶液-给药途径：肌肉注射
实验性的：Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 4
participants received a single dose of QIV mRNA vaccine MRT5429
生物：四价流感 mRNA 疫苗 MRT5429
剂型：小瓶溶液-给药途径：肌肉注射
实验性的：Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 1
participants received a single dose of QIV mRNA vaccine MRT5424
生物：四价流感 mRNA 疫苗 MRT5424
剂型：小瓶溶液给药途径：肌肉注射
实验性的：Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 2
participants received a single dose of QIV mRNA vaccine MRT5424
生物：四价流感 mRNA 疫苗 MRT5424
剂型：小瓶溶液给药途径：肌肉注射
有源比较器：Quadrivalent Influenza SD Vaccine
participants received a single dose of QIV-SD vaccine
生物：四价流感标准剂量疫苗
剂型：预充式注射器注射用混悬液-给药途径：肌肉注射
其他名称：
  • Fluzone Qudrivalent®
有源比较器：Quadrivalent Influenza HD Vaccine
participants received a single dose of QIV -HD vaccine (for adults ≥ 65 years of age only)
生物：四价流感大剂量疫苗
剂型：预充式注射器注射用混悬液-给药途径：肌肉注射
其他名称：
  • Fluzone 高剂量 Quadrivalent®
有源比较器：Quadrivalent Influenza RIV4 Vaccine
participants received a single dose of RIV4 vaccine
生物：四价重组流感疫苗
剂型：预充式注射器注射用混悬液-给药途径：肌肉注射
其他名称：
  • Flublok Quadrivalent®

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
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) After Vaccine Administration
大体时间：Within 30 minutes after vaccine administration on Day 1
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.
Within 30 minutes after vaccine administration on Day 1
Number of Participants With Solicited Injection Site Reactions After Vaccine Administration
大体时间：Within 7 days after vaccine administration on Day 1
An adverse reaction (AR) is any noxious and unintended response to a study vaccine related to any dose. Solicited injection site reactions are reactions at and around the injection site of the vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form.
Within 7 days after vaccine administration on Day 1
Number of Participants With Solicited Systemic Reactions After Vaccine Administration
大体时间：Within 7 days after vaccine administration on Day 1
An AR is any noxious and unintended response to a study vaccine related to any dose. Solicited systemic reactions are systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form.
Within 7 days after vaccine administration on Day 1
Number of Participants With Unsolicited Adverse Events After Vaccine Administration
大体时间：Within 28 days after vaccine administration on Day 1
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination.
Within 28 days after vaccine administration on Day 1
Number of Participants With Medically Attended Adverse Events (MAAEs)
大体时间：Within 180 days after vaccine administration on Day 1
An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.
Within 180 days after vaccine administration on Day 1
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
大体时间：From the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days
An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. An AESI (serious or non-serious) is 1 of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. The AESIs was defined as anaphylactic reactions (including bronchospasms, and laryngeal spasms), Guillain-Barré syndrome, neuritis (including Bell's palsy), myocarditis, pericarditis, myopericarditis and vasculitis.
From the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days
Number of Participants With Abnormal Biological Test Results
大体时间：Within 8 days after vaccine administration on Day 1
Blood samples were collected for the assessment of abnormal hematology and clinical chemistry parameters. Only participants with outside the normal range hematology and clinical chemistry parameters are reported.
Within 8 days after vaccine administration on Day 1
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 1
大体时间：Day 1
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% confidence interval (CI) was based on the Clopper-Pearson method.
Day 1
Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 29
大体时间：Day 29
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI was based on the Clopper-Pearson method.
Day 29
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
大体时间：Day 1
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Day 1
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 29
大体时间：Day 29
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Day 29
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 29
大体时间：Days 1 and 29
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Clopper-Pearson method.
Days 1 and 29
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 29
大体时间：Day 29
The seroconversion was defined as titer <10 on Day 1 and post-injection titer >=40 on Day 29; or defined as titer >=10 on Day 1 and a >=4-fold increase in titer on Day 29. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Day 29
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 29
大体时间：Day 29
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Day 29
Percentage of Participants With >=2 and >=4 Fold Increase in Hemagglutination Inhibition Antibody Titer at Day 29
大体时间：Days 1 and 29
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Days 1 and 29

次要结果测量

结果测量
措施说明
大体时间
Geometric Mean of Neutralization Test (NT) Antibody Titer at Days 1 and 29
大体时间：Days 1 and 29
The NT Ab was planned to be measured using seroneutralization (SN) measurement method. The 95% CI was planned to be calculated using the Clopper-Pearson method.
Days 1 and 29
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 29
大体时间：Days 1 and 29
The NT Ab was planned to be measured using SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination was planned to be reported. The 95% CI was planned to be calculated using the Clopper-Pearson method.
Days 1 and 29
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 29
大体时间：Days 1 and 29
The NT Ab was planned to be measured using SN measurement method. The 95% CI for the single percentage was planned to be calculated using the Clopper-Pearson method.
Days 1 and 29

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

Sanofi Pasteur, a Sanofi Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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)

2024年4月1日

初级完成 (实际的)

2025年6月9日

研究完成 (实际的)

2025年6月9日

研究注册日期

首次提交

2024年4月4日

首先提交符合 QC 标准的

2024年4月10日

首次发布 (实际的)

2024年4月12日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年7月9日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • VAV00045
  • U1111-1295-2852 (注册表标识符：ICTRP)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

合格的研究人员可以请求访问患者水平数据和相关研究文件，包括临床研究报告、带有任何修订的研究方案、空白病例报告表、统计分析计划和数据集规范。 患者级别的数据将被匿名化，研究文件将被编辑，以保护试验参与者的隐私。 有关赛诺菲数据共享标准、合格研究以及请求访问流程的更多详细信息，请访问：https://vivli.org

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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