A Study of Updated mRNA Seasonal Influenza Vaccines
A Phase 3b/4 Study to Assess the Immunogenicity and Safety of Updated mRNA Seasonal Influenza Vaccine Compositions
The purpose of this study is to evaluate the immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines within the current epidemiological environment.
研究概览
详细说明
This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines. As different strain-containing vaccine compositions will be evaluated, each study intervention will be described in the subprotocol. For each evaluation of an updated strain, a new subprotocol will be generated. Reported outcome measures are based upon each subprotocol. Not all reported outcome measures may be applicable to each subprotocol.
Subprotocol 01 is to evaluate the 2026-2027 mRNA influenza vaccine.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Moderna WeCare Team
- 电话号码:1-866-663-3762
- 邮箱:WeCareClinicalTrials@modernatx.com
学习地点
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Arizona
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Tucson、Arizona、美国、85711
- 招聘中
- Arizona Clinical Trials
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Kansas
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Lenexa、Kansas、美国、66219
- 招聘中
- Johnson County Clin-Trials LLC (JCCT)
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Kentucky
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Louisville、Kentucky、美国、40205
- 招聘中
- DelRicht Research at Derby City Direct Primary Care
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Missouri
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Town and Country、Missouri、美国、63017
- 招聘中
- DelRicht Research at Amy Roberts MD and Associates
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Female participants must be of non-childbearing potential.
Key Exclusion Criteria:
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4° Fahrenheit [F]]) within 72 hours prior to at the Screening Visit or Day 1.
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, could interfere with interpretation of study results or limit the participant's participation in the study.
- History of myocarditis, pericarditis, or myopericarditis within 90 days prior to Day 1 (Baseline).
- Received corticosteroids at ≥10 mg/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or within 28 days after Day 1.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
- Tested positive for influenza by US Centers for Disease Control and Prevention (CDC)-recommended testing methods within 180 days prior to Day 1.
- Received systemic immunoglobulins or blood products within 90 days prior to Day 1 (Baseline) or plans to do so during the study.
- Received any vaccine (excluding seasonal influenza vaccine) authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline).
- Received a licensed or investigational seasonal influenza vaccine within 6 months prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
学习计划
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 |
|---|---|
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实验性的:mRNA-1010 Influenza Strain-containing Composition (2026- 2027)
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
Sterile liquid for injection |
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有源比较器:Licensed High-Dose Seasonal Influenza Vaccine
Participants will receive a single dose of licensed high-dose seasonal influenza vaccine by IM injection on Day 1. |
Sterile liquid for injection |
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 |
|---|---|---|
|
第 29 天抗血凝素 (HA) 抗体的几何平均滴度 (GMT),通过血凝抑制 (HAI) 测定法测量
大体时间:第 29 天
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第 29 天
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Number of Participants Reaching Seroconversion at Day 29 as Measured by HAI Assay
大体时间:Day 29
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Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay. |
Day 29
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Number of Participants with an HAI Titer ≥1:40 at Day 29
大体时间:Day 29
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Day 29
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Geometric Mean Fold Rise (GMFR), as Measured by HAI Assay
大体时间:Baseline to Day 29
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Baseline to Day 29
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Number of Participants with Unsolicited Adverse Events (AEs)
大体时间:Day 1 through Day 29
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Day 1 through Day 29
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Number of Participants with Serious AEs, Medical-attended AEs and AE of Interest, and AEs Leading to Discontinuation
大体时间:Day 1 through Day 29
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Day 1 through Day 29
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- mRNA-1010-P401
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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