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一项评估VAX-31与流感疫苗在≥50岁成人中的安全性、耐受性和免疫原性的临床研究

2026年11月10日 更新者：Vaxcyte, Inc.

一项针对50岁及以上健康受试者评估VAX-31与季节性流感疫苗联合接种的安全性、耐受性和免疫原性的3期随机双盲安慰剂对照临床研究

This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.

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)

1390

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
    • Arizona
      • Phoenix、Arizona、美国、85032
        • Hope Research Institute
    • Colorado
      • Fort Collins、Colorado、美国、80525
        • Tekton Research at Fort Collins
    • Florida
      • DeLand、Florida、美国、32720-0834
        • University Clinical Research - Deland
      • Hollywood、Florida、美国、33024
        • CenExel Research Centers of America
      • Jupiter、Florida、美国、33458
        • Health Awareness
      • Lakeland、Florida、美国、33803
        • Accel Research Sites - Lakeland
      • Largo、Florida、美国、33777
        • Accel Research Sites - Largo
      • Sunrise、Florida、美国、33351
        • Precision Clinical Research
    • Indiana
      • Valparaiso、Indiana、美国、46383
        • Velocity Valparaiso
    • Kansas
      • Lenexa、Kansas、美国、66219
        • Johnson County ClinTrials
    • Kentucky
      • Lexington、Kentucky、美国、40509
        • AMR Lexington
    • Michigan
      • Detroit、Michigan、美国、48076
        • DM Clinical Research - Detroit
    • Nebraska
      • Omaha、Nebraska、美国、68134
        • Velocity Omaha
    • New York
      • Rochester、New York、美国、14609
        • Rochester Clinical Research
    • Ohio
      • Cincinnati、Ohio、美国、45212
        • CTI Clinical Research Center
    • South Carolina
      • North Charleston、South Carolina、美国、29405
        • Coastal Carolina Research Center
    • Tennessee
      • Hendersonville、Tennessee、美国、37075
        • DelRicht Research - Hendersonville
      • Knoxville、Tennessee、美国、37909
        • AMR Knxoville
    • Texas
      • Austin、Texas、美国、78745
        • Tekton Research at Austin
      • Beaumont、Texas、美国、77701
        • REX Clinical Trials
      • DeSoto、Texas、美国、75115
        • Epic Medical Research
    • Utah
      • Salt Lake City、Utah、美国、84107
        • CenExel JBR Clinical Research
    • Virginia
      • Charlottesville、Virginia、美国、22911
        • Charlottesville Medical Research Center
      • Newport News、Virginia、美国、23606
        • Health Research of Hampton Roads, Inc.
      • Richmond、Virginia、美国、23226
        • Clinical Research Partners, LLC.

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

50年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Male or female ≥50 years of age (inclusive) at the time of randomization into the study.
  2. Able and willing to complete the informed consent process.
  3. Available for clinical follow-up through the last study visit at 7 months after the first study vaccination.
  4. In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator.
  5. Willing to have blood samples collected and used for research purposes.
  6. Able to provide proof of identity to the satisfaction of the study site personnel completing the enrollment process.
  7. Female subjects of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test at Screening and immediately prior to each vaccination and agree to use acceptable contraception, if heterosexually active. Female subjects who are not abstinent from heterosexual intercourse must agree to consistently practice contraception at least 7 days prior to vaccination and through their last study visit. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method ([use condoms with or without spermicide] or have undergone a vasectomy) from Day 1 through their last study visit. Note: A history of amenorrhea for at least 12 months without an alternative medical cause is required for a female to be considered postmenopausal in the study.
  8. Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).

Exclusion Criteria:

  1. History of IPD or pneumococcal pneumonia (either confirmed or self-reported) at any age.
  2. Previous receipt of a licensed or investigational pneumococcal vaccine at any age.
  3. Previous receipt of an influenza vaccine from the current season; receipt of any influenza vaccine (licensed or investigational) within 6 months prior to Day 1; or receipt/planned receipt of any licensed or investigational non-study influenza vaccine during study participation.
  4. Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
  5. Planned or actual administration of any licensed vaccine within 30 days prior to Day 1.
  6. Body temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (participant may be rescreened).
  7. Current diagnosis of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
  8. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination.
  9. History of Guillain-Barré syndrome.
  10. Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation.
  11. Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency.
  12. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
  13. Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to Day 1.
  14. Receiving immunosuppressive therapy.
  15. Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent >10 mg/day) within 14 days of study vaccinations. Note: Receipt of a ≥14-day course of systemic corticosteroids equivalent to ≤10 mg/day is permitted, as are inhaled, nebulized, topical, intra-articular, and intrabursal corticosteroids.
  16. History of malignancy ≤5 years before to Day 1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  17. Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
  18. Employee of, or first-degree relative of any person employed by the Sponsor, the contract research organization (CRO), the Investigator, study site personnel, or site.

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：VAX-31 + SIV

Participants will receive a single dose of VAX-31 administered as an intramuscular injection at Day 1, concomitantly administered with SIV, followed by placebo at Month 1.
生物：31-valent pneumococcal conjugate vaccine

0.5 mL of VAX-31 will be administered into the deltoid muscle

生物：Seasonal Influenza Vaccine (SIV) (Flublok)

0.5 mL of SIV into the deltoid muscle

生物：Placebo

0.5mL of placebo (normal saline) into the deltoid muscle
实验性的：Placebo + SIV

Participants will receive placebo administered via intramuscular injection at Day 1, concomitantly administered with SIV, followed by VAX-31 at Month 1.
生物：31-valent pneumococcal conjugate vaccine

0.5 mL of VAX-31 will be administered into the deltoid muscle

生物：Seasonal Influenza Vaccine (SIV) (Flublok)

0.5 mL of SIV into the deltoid muscle

生物：Placebo

0.5mL of placebo (normal saline) into the deltoid muscle

研究衡量的是什么？

主要结果指标

结果测量
大体时间
对于32种血清型（包括在VAX-31中的31种血清型以及血清型20B）中的每一种，可评估参与者中调理吞噬活性（OPA）几何平均滴度（GMT）的比率（共同给药组与顺序给药组之比）
大体时间：VAX-31疫苗接种后1个月
VAX-31疫苗接种后1个月
对于SIV中的每种毒株，可评估参与者中血凝抑制（HAI）GMT的比率（联合给药组与序贯给药组）
大体时间：SIV给药后1个月
SIV给药后1个月
各组中在首次接种和1个月接种后7天内报告诱发性局部不良事件（注射部位发红、肿胀和疼痛）的参与者百分比
大体时间：每次接种后7天
每次接种后7天
各组中在首次接种和第1个月接种后7天内报告引发的全身性不良反应（发热、头痛、疲劳、肌肉疼痛和关节疼痛）的参与者百分比
大体时间：每次接种后7天
每次接种后7天
各组参与者在第1天及第1个月疫苗接种后1个月内报告非请求不良事件的发生比例
大体时间：每次接种后7天
每次接种后7天
每组在最后一次接种后6个月内报告NOCI、MAAE和SAE的参与者百分比
大体时间：末次接种后6个月
末次接种后6个月

次要结果测量

结果测量
大体时间
针对32种血清型（包括在VAX-31中的31种血清型，以及血清型20B），在可评估参与者中，共同接种组与序贯接种组的免疫球蛋白G几何平均浓度（GMC）比值
大体时间：VAX-31给药后1个月
VAX-31给药后1个月

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

Vaxcyte, 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)

2026年1月12日

初级完成 (实际的)

2026年10月21日

研究完成 (实际的)

2026年10月21日

研究注册日期

首次提交

2026年1月22日

首先提交符合 QC 标准的

2026年1月22日

首次发布 (实际的)

2026年1月26日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11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

  • VAX31-106

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

Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.

IPD 共享时间框架

Individual participant data will be shared after deidentification and made available starting 6 months after initial product approval.

IPD 共享访问标准

Criteria will depend on the specific proposal received and may include qualification of the scientific researchers, potential contribution to the research field, scientific rigor of statistical and analytical methods, and other criteria appropriate for the proposal.

IPD 共享支持信息类型

  • 研究方案

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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