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帮助健康儿童预防莱姆病的疫苗的安全性研究

2026年4月14日 更新者：Pfizer

一项 3 期、随机、安慰剂对照、观察员设盲的试验，以评估基于 6 价 OspA 的莱姆病疫苗 (VLA15) 在 5 至 17 岁健康儿童中的安全性

本研究旨在了解研究疫苗（称为 VLA15）对健康儿童是否安全。

我们正在寻找符合以下条件的孩子：

  • 很健康
  • 年龄在 5 到 17 岁之间
  • 过去没有被诊断出患有任何形式的莱姆病
  • 过去没有接种过任何莱姆病疫苗

莱姆病最常发生在这个年龄段的儿童身上。 该研究疫苗可能用于帮助预防莱姆病。 本研究的目的是获得更多有关该年龄组研究疫苗安全性的信息。

参与者将参与这项研究大约 2 年。 在此期间，他们将通过手臂“注射”获得 VLA15 或安慰剂（无菌盐水）。 我们将比较接受 VLA15 的儿童与接受安慰剂的儿童的经历。 参与者将不知道他们得到的是 VLA15 还是安慰剂。

参与这项研究的每个人都将：

  • 在诊所或医院办公室注射
  • 总共收到 4 张照片
  • 在 6 个月内收到前 3 针
  • 大约 1 年后收到最后一针
  • 需要到试验地点进行 6 次计划访视；其中 4 次是疫苗接种访问，2 次是后续访问。 我们将在研究期间每年通过电话与您联系 1 次，以监控您的体验。 如果您在接种疫苗后出现严重反应，您可能需要额外就诊。

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)

3547

阶段

  • 第三阶段

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
    • Alabama
      • Birmingham、Alabama、美国、35233
        • University of Alabama at Birmingham - School of Medicine
      • Birmingham、Alabama、美国、35233
        • UAB Child Health Research Unit (CHRU)
      • Guntersville、Alabama、美国、35976
        • Lakeview Clinical Research
    • California
      • Bellflower、California、美国、90706
        • Coast Clinical Research, LLC
      • Fair Oaks、California、美国、95628
        • Apex Research Group LLC
    • Connecticut
      • Bridgeport、Connecticut、美国、06606
        • New England Research Associates
      • Stamford、Connecticut、美国、06905
        • Stamford Therapeutics Consortium
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20010
        • Children's National Medical Center
    • Florida
      • Miami、Florida、美国、33144
        • Bio-Medical Research LLC
      • St. Petersburg、Florida、美国、33705
        • GCP Research, Global Clinical professionals
      • Tampa、Florida、美国、33613
        • ForCare Clinical Research
      • Tampa、Florida、美国、33609
        • MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
    • Georgia
      • Chamblee、Georgia、美国、30341
        • Tekton Research, LLC.
    • Idaho
      • Boise、Idaho、美国、83702
        • ASR, LLC
      • Idaho Falls、Idaho、美国、83404
        • Clinical Research Prime
      • Rexburg、Idaho、美国、83440
        • Clinical Research Prime Rexburg
    • Illinois
      • Chicago、Illinois、美国、60637
        • University Of Chicago Medical Center
    • Kansas
      • El Dorado、Kansas、美国、67042
        • AMR Clinical
      • Wichita、Kansas、美国、67207
        • AMR Clinical
    • Kentucky
      • Bardstown、Kentucky、美国、40004
        • Kentucky Pediatric/ Adult Research
      • Louisville、Kentucky、美国、40243
        • All Children Pediatrics
    • Maryland
      • Oxon Hill、Maryland、美国、20745
        • MD Medical Research
      • Silver Spring、Maryland、美国、20904
        • White Oak Pediatrics
    • Massachusetts
      • Springfield、Massachusetts、美国、01103
        • Sisu BHR
    • Michigan
      • Bingham Farms、Michigan、美国、48025
        • Michigan Center of Medical Research (MICHMER)
      • Dearborn Heights、Michigan、美国、48127
        • Vida Clinical Studies, LLC
      • Southfield、Michigan、美国、48075
        • Great Lakes Research Institute
    • Minnesota
      • Minneapolis、Minnesota、美国、55402
        • Clinical Research Institute
    • Nebraska
      • Omaha、Nebraska、美国、68134
        • Velocity Clinical Research, Omaha
    • New Jersey
      • Marlton、New Jersey、美国、08053
        • Hassman Research Institute
      • New Brunswick、New Jersey、美国、08901
        • Rutgers University
      • Warren Township、New Jersey、美国、07059
        • IMA Clinical Research Warren
    • New York
      • Binghamton、New York、美国、13905
        • Velocity Clinical Research, Binghamton
      • Buffalo、New York、美国、14203
        • Buffalo Clinical and Translational Research Center
      • Commack、New York、美国、11725
        • Advanced Specialty Care
      • Cortland、New York、美国、13045
        • Smith Allergy and Asthma Specialists
      • East Setauket、New York、美国、11733
        • Stony Brook Medicine Clinical Research Center
      • East Syracuse、New York、美国、13057
        • Upstate Global Health Institute
      • Hampton Bays、New York、美国、11946
        • Southampton Hospital
      • Horseheads、New York、美国、14845
        • Smith Allergy & Asthma Specialists
      • Mineola、New York、美国、11501
        • NYU Langone Hospital - Long Island
      • North Massapequa、New York、美国、11758
        • DiGiovanna Institute for Medical Education & Research
      • Rochester、New York、美国、14609
        • Rochester Clinical Research, LLC
      • Stony Brook、New York、美国、11794
        • Stony Brook University
      • The Bronx、New York、美国、10456
        • Prime Global Research
      • The Bronx、New York、美国、10467
        • Advantage Clinical Trials
      • Vestal、New York、美国、13850
        • Velocity Clinical Research, Vestal
    • Ohio
      • Columbus、Ohio、美国、43213
        • Centricity Research Columbus Ohio Multispecialty
    • Pennsylvania
      • Erie、Pennsylvania、美国、16506
        • Allegheny Health and Wellness Pavilion
      • Erie、Pennsylvania、美国、16508
        • Central Erie Primary Care
      • Pittsburgh、Pennsylvania、美国、15236
        • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
      • Scranton、Pennsylvania、美国、18510
        • Northeast Clinical Trials Group
    • South Carolina
      • North Charleston、South Carolina、美国、29405
        • Coastal Carolina Research Center
    • Texas
      • Austin、Texas、美国、78705
        • Benchmark Research
      • Fort Worth、Texas、美国、76135
        • Benchmark Research
      • Fort Worth、Texas、美国、76135
        • Texas Health Resources
      • Houston、Texas、美国、77022
        • C & R Research Services USA
      • Houston、Texas、美国、77065
        • DM Clinical Research - Kool Kids Pediatrics
      • Plano、Texas、美国、75093
        • Research Your Health
      • San Antonio、Texas、美国、78215
        • Sun Research Institute
    • Utah
      • West Jordan、Utah、美国、84088
        • Velocity Clinical Research, Salt Lake City
    • Virginia
      • Charlottesville、Virginia、美国、22902
        • Pediatric Research of Charlottesville, LLC
      • Richmond、Virginia、美国、23226
        • Clinical Research Partners, LLC
    • West Virginia
      • Kingwood、West Virginia、美国、26537
        • Frontier Clinical Research
      • Kingwood、West Virginia、美国、26537
        • Preston Healthcare Services

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

5年 至 17年 (孩子)

接受健康志愿者

是的

描述

纳入标准：

  • 入组时确定有资格纳入研究的健康参与者。 可以包括确定为稳定的先前存在的慢性疾病的参与者。
  • 参与者和/或参与者的父母/监护人愿意并能够在研究期间遵守所有预定的访问、研究程序和生活方式注意事项。

排除标准：

  • 怀孕、哺乳或在访问 1 时尿妊娠试验呈阳性的女性参与者。性活跃的女性和生育能力强的男性不愿按照协议采取避孕措施。
  • 疫苗接种或疫苗成分的任何禁忌症，包括之前对任何疫苗或疫苗相关成分的过敏反应。
  • 在过去 3 个月内诊断出莱姆病。
  • 任何莱姆关节炎、心脏炎、神经疏螺旋体病或其他播散性莱姆病 (LD) 病史，无论何时确诊。
  • 过去 4 周内已知被蜱叮咬过。
  • 先天性或获得性免疫缺陷或与免疫抑制相关的其他病症或治疗会抑制对疫苗产生免疫反应的能力。
  • 其他医学、精神疾病、主动自杀意念/行为或实验室异常，会增加参与研究的风险，或者研究者判断不适合研究。
  • 之前接受过 LD 疫苗接种的收据。
  • 在研究干预管理之前的 3 个月内接受过 LD 治疗。
  • 从研究结束到研究干预实施前 6 个月内收到血液/血浆制品或免疫球蛋白。
  • 在研究干预给药前 28 天内接受全身性皮质类固醇≥14 天。 允许吸入/雾化、关节内、囊内或局部皮质类固醇。
  • 在研究干预实施之前的 6 个月内接受过其他已知免疫抑制药物或放疗的慢性全身治疗。
  • 当前使用任何禁用的伴随药物或参与者不愿意/不能使用允许的伴随药物。
  • 在进入研究前 28 天内和/或参与研究期间参与涉及研究性药物/疫苗/设备的其他研究（观察性研究是可接受的）。
  • 研究者现场工作人员、直接参与研究开展的申办方/申办方代表及其家属；由调查员及其家属监督的现场工作人员。

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：其他
  • 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：VLA15
参与者将接受基于 6 价 OspA 的莱姆病疫苗 (VLA15)。
生物：VLA15
基于 6 价 OspA 的莱姆病疫苗
其他名称：
  • PF-07307405
安慰剂比较：生理盐水（安慰剂）
参加者将接受 0.9% 氯化钠注射液
其他：生理盐水
0.9%氯化钠注射液

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
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 1
大体时间：From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 2
大体时间：From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 3
大体时间：From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)
大体时间：From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days After Any Study Vaccination
大体时间：From Day 1 through Day 7 after any study vaccination
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after any study vaccination
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 1
大体时间：From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 2
大体时间：From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 3
大体时间：From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)
大体时间：From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days After Any Study Vaccination
大体时间：From Day 1 through Day 7 after any study vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after any study vaccination
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 1
大体时间：From Day 1 through 1 Month after Study Vaccination 1 (Vaccination on Day 1, Month 0)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 1 were included in this outcome measure. AEs included both serious AEs (SAEs) and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 2
大体时间：From Day 1 through 1 Month after Study Vaccination 2 (Vaccination on Day 1, Month 2)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 2 were included in this outcome measure. AEs included both SAEs and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 3
大体时间：From Day 1 through 1 Month after Study Vaccination 3 (Vaccination on Day 1, Month 6)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 3 were included in this outcome measure. AEs included both SAEs and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 4 (Booster Dose)
大体时间：From Day 1 through 1 Month after Study Vaccination 4 (Vaccination on Day 1, Month 18)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 4 were included in this outcome measure. AEs included both SAEs and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Percentage of Participants With AEs Through 1 Month Following Any Study Vaccination
大体时间：From Day 1 through 1 Month after any study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after any dose were included in this outcome measure.
From Day 1 through 1 Month after any study vaccination
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
大体时间：Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. NDCMCs included conditions that were undiagnosed prior to study entry (diagnosed while in the study and confirmed not to be a preexisting condition) and that were not considered temporary conditions based upon the expected natural history of the condition. An NDCMC was not reported on AE CRF.
Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
大体时间：Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
An 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 important medical event.
Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)

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

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)

2022年12月12日

初级完成 (实际的)

2025年7月21日

研究完成 (实际的)

2025年7月21日

研究注册日期

首次提交

2022年11月22日

首先提交符合 QC 标准的

2022年11月22日

首次发布 (实际的)

2022年12月2日

研究记录更新

最后更新发布 (实际的)

2026年5月7日

上次提交的符合 QC 标准的更新

2026年4月14日

最后验证

2026年4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

  • C4601012
  • NCT05634811 (注册表标识符：ClinicalTrials.gov)
  • 2025-000441-15 (EudraCT编号)

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

辉瑞将提供对个人去识别参与者数据和相关研究文件（例如 协议、统计分析计划 (SAP)、临床研究报告 (CSR)）根据合格研究人员的要求，并遵守某些标准、条件和例外情况。 有关辉瑞数据共享标准和请求访问流程的更多详细信息，请访问：https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests。

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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