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A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults

2026年8月26日 更新者：Pfizer

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS

The purpose of this study is to provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine.

This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines.

The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC.

Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 participants, about 2 will receive either PG4 lot 1, lot 2 or lot 3 and about 1 will receive 20vPnC.

Each participant will take part in the study for approximately 6 months.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

4670

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。

学习联系方式

学习地点

  • 美国
    • California
      • Lake Forest、California、美国、92630
        • Orange County Research Center
      • Walnut Creek、California、美国、94598
        • Diablo Clinical Research, LLC dba Flourish Research
    • Connecticut
      • Milford、Connecticut、美国、06460
        • Clinical Research Consulting
    • Florida
      • Doral、Florida、美国、33172
        • Suncoast Research Associates
      • Miami、Florida、美国、33176
        • Entrust Clinical Research
      • Miami Lakes、Florida、美国、33014
        • Palm Springs Community Health Center
      • Miami Lakes、Florida、美国、33016
        • Indago Research and Health Center, Inc.
      • West Palm Beach、Florida、美国、33409
        • Palm Beach Research Center
    • Georgia
      • Fayetteville、Georgia、美国、30214
        • Javara inc.
      • Stockbridge、Georgia、美国、30281
        • Clinical Research Atlanta
    • Hawaii
      • Honolulu、Hawaii、美国、96814
        • East-West Medical Research Institute
    • Illinois
      • Melrose Park、Illinois、美国、60160
        • DM Clinical Research
    • Iowa
      • Sioux City、Iowa、美国、51106
        • Velocity Clinical Research, Sioux City
    • Michigan
      • Grosse Pointe Woods、Michigan、美国、48236
        • Henry Ford St. John Hospital - Thomas Mackey Center for Infectious Disease Research
    • Missouri
      • Chesterfield、Missouri、美国、63005
        • Clinical Research Professionals
    • Nebraska
      • Grand Island、Nebraska、美国、68803
        • Velocity Clinical Research, Grand Island
    • North Carolina
      • Wilmington、North Carolina、美国、28401
        • Accellacare - Wilmington
    • Ohio
      • Cincinnati、Ohio、美国、45212
        • CTI Clinical Research Center
    • South Carolina
      • Moncks Corner、South Carolina、美国、29461
        • Clinical Trials of South Carolina
      • Myrtle Beach、South Carolina、美国、29572
        • TMA Headlands LLC (d/b/a Trial Management Associates)
    • Texas
      • Mesquite、Texas、美国、75149
        • SMS Clinical Research LLC
      • Sugar Land、Texas、美国、77478
        • DM Clinical Research - Sugar Land
      • Tomball、Texas、美国、77375
        • 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

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

接受健康志愿者

是的

描述

Inclusion Criteria:

Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age.

Exclusion Criteria:

Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.

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：PG4 Vaccine Lot 1
Multivalent Pneumococcal Vaccine
生物：PG4 Multivalent Vaccine
Multivalent Pneumococcal Vaccine
其他名称：
  • PG4 Lot 3
实验性的：PG4 Vaccine Lot 2
Multivalent Pneumococcal Vaccine
生物：PG4 Multivalent Vaccine
Multivalent Pneumococcal Vaccine
其他名称：
  • PG4 Lot 3
实验性的：PG4 Vaccine Lot 3
Multivalent Pneumococcal Vaccine
生物：PG4 Multivalent Vaccine
Multivalent Pneumococcal Vaccine
其他名称：
  • PG4 Lot 3
有源比较器：20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
20 Valent Pneumococcal Conjugate Vaccine
生物：20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
20 Valent Pneumococcal Conjugate Vaccine
其他名称：
  • 普雷夫纳尔 20

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 Prespecified Local Reactions Within 7 Days After Vaccination
大体时间：Within 7 days after Vaccination
Prompted local reactions after each dose
Within 7 days after Vaccination
Percentage of Participants reporting Prespecified Systemic Events Within 7 Days after Vaccination
大体时间：Within 7 days after Vaccination
Prompted systemic events after each dose
Within 7 days after Vaccination
Percentage of Participants with Adverse Events (AEs)
大体时间：From Vaccination to 1 month after Vaccination
AEs occurring from Dose 1 to 1 month after the vaccination
From Vaccination to 1 month after Vaccination
Percentage of Participants with Serious Adverse Events (SAEs)
大体时间：From Vaccination to 6 months after Vaccination
SAEs occurring from Dose 1 to 6 months after the vaccination
From Vaccination to 6 months after Vaccination
OPA geometric mean ratios (GMR) between each pair of PG4 vaccine lots
大体时间：1 month after Vaccination
OPA GMRs between each pair of PG4 vaccine lots at 1 month after vaccination
1 month after Vaccination

次要结果测量

结果测量
措施说明
大体时间
OPA Serotype-specific geometric mean titers (GMT) for PG4 vaccine serotypes
大体时间：1 month after Vaccination
OPA GMTs at 1 month after vaccination
1 month after Vaccination
OPA geometric mean fold rise (GMFR) for PG4 vaccine serotypes
大体时间：From before vaccination to 1 month after vaccination
GMFRs in OPA titers from before to 1 month after vaccination
From before vaccination to 1 month after vaccination
Percentages of participants with a ≥4-fold rise in opsonophagocytic activity (OPA) titers
大体时间：From Vaccination to 6 months after Vaccination
Percentages of participants with a ≥4-fold rise in OPA titers from before to 1 month after vaccination
From Vaccination to 6 months after Vaccination
Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ)
大体时间：From before vaccination to 1 month after vaccination
Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ) from before vaccination to 1 month after vaccination
From before vaccination to 1 month after vaccination

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 (估计的)

2026年9月8日

初级完成 (估计的)

2027年6月7日

研究完成 (估计的)

2027年6月7日

研究注册日期

首次提交

2026年8月26日

首先提交符合 QC 标准的

2026年8月26日

首次发布 (实际的)

2026年8月31日

研究记录更新

最后更新发布 (实际的)

2026年8月31日

上次提交的符合 QC 标准的更新

2026年8月26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

  • C4931012

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

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: 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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