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一项研究健康人中流感和共同疫苗反应的研究

2026年8月17日 更新者：BioNTech SE

一项1/2阶段，随机，观察者盲的研究，以评估健康个体中对流感和COVID-19的联合疫苗候选者的安全性，耐受性和免疫原性

这项研究是单独或混合时了解流感和共同疫苗。 18岁或以上的健康人可以加入。 参与者将单独或混合的每只手臂中的每只手臂射击一次。 该研究持续约6个月，参与者需要至少访问研究站点3次。

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)

1353

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

  • 美国
    • California
      • Lake Forest、California、美国、92630
        • Orange County Research Center
      • San Diego、California、美国、92103
        • Artemis Institute for Clinical Research
      • Walnut Creek、California、美国、94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • Milford、Connecticut、美国、06460
        • Clinical Research Consulting
    • Florida
      • Hialeah、Florida、美国、33012
        • Indago Research & Health Center, Inc
      • Miami、Florida、美国、33176
        • Miami Dade Medical Research Institute, LLC
      • Miami Lakes、Florida、美国、33014
        • Palm Springs Community Health Center
      • Orlando、Florida、美国、32819
        • Headlands Research Orlando
    • Georgia
      • Stockbridge、Georgia、美国、30281
        • Clinical Research Atlanta
    • Hawaii
      • Honolulu、Hawaii、美国、96814
        • East-West Medical Research Institute
    • Missouri
      • Chesterfield、Missouri、美国、63005
        • Clinical Research Professionals
      • Springfield、Missouri、美国、65802
        • Bio-Kinetic Clinical Applications, LLC dba QPS-MO
      • Springfield、Missouri、美国、65807
        • Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
    • Nebraska
      • Omaha、Nebraska、美国、68134
        • Velocity Clinical Research, Omaha
    • Nevada
      • Las Vegas、Nevada、美国、89030
        • Las Vegas Clinical Trials
    • New Hampshire
      • Portsmouth、New Hampshire、美国、03801
        • ActivMed Practices & Research, LLC.
    • Texas
      • Houston、Texas、美国、77065
        • DM Clinical Research- Cyfair
      • Mesquite、Texas、美国、75149
        • SMS Clinical Research
      • Tomball、Texas、美国、77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    • Utah
      • Salt Lake City、Utah、美国、84109
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City、Utah、美国、84121
        • J. Lewis Research, Inc. / Foothill Family Clinic South
    • Virginia
      • Charlottesville、Virginia、美国、22911
        • Charlottesville Medical Research

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

纳入标准：

  • 参与者18岁或以上
  • 由病史确定的健康参与者，身体检查（如果需要临床需要）以及研究人员的临床判断有资格纳入研究。

排除标准：

  • 疫苗接种任何研究或许可的2024-2025季节制剂流感或Covid-19疫苗。
  • 在第1天前180天内，用抗病毒疗法（例如，tamiflu）治疗

请参阅研究联系人以获取更多资格详细信息。

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：Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
生物：2019冠状病毒病疫苗
辉瑞-biontech Covid-19疫苗
实验性的：Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
生物：2019冠状病毒病疫苗
辉瑞-biontech Covid-19疫苗
有源比较器：Arm C/CC
High Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
生物：2019冠状病毒病疫苗
辉瑞-biontech Covid-19疫苗
实验性的：Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
其他：安慰剂
盐水
生物：研究性流感疫苗
研究性流感疫苗
有源比较器：Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
生物：2019冠状病毒病疫苗
辉瑞-biontech Covid-19疫苗
生物：许可的流感疫苗1
许可的流感疫苗1
有源比较器：Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
生物：2019冠状病毒病疫苗
辉瑞-biontech Covid-19疫苗
生物：许可的流感疫苗2
许可的流感疫苗2
实验性的：Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
其他：安慰剂
盐水
生物：研究性流感疫苗
研究性流感疫苗
实验性的：Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
组合产品：Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
实验性的：Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
组合产品：Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
实验性的：Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
组合产品：Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
实验性的：Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
其他：安慰剂
盐水
生物：研究性流感疫苗
研究性流感疫苗
实验性的：Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
组合产品：Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
实验性的：Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
组合产品：Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
实验性的：Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
组合产品：Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
实验性的：Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
其他：安慰剂
盐水
组合产品：Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

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
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
大体时间：From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
大体时间：From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
大体时间：From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
大体时间：From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination
大体时间：From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination
大体时间：From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
大体时间：From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
大体时间：From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]

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

BioNTech SE

合作者

Pfizer

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

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11月11日

初级完成 (实际的)

2025年7月15日

研究完成 (实际的)

2025年7月15日

研究注册日期

首次提交

2024年11月8日

首先提交符合 QC 标准的

2024年11月8日

首次发布 (实际的)

2024年11月12日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8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

  • C5261023
  • C5261023-C1; C5261023-C2 (其他标识符：Alias Study Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

在美国制造并从美国出口的产品

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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