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Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents

2026年8月27日 更新者：Pfizer

A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).

This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae

This study is seeking participants who:

  • Are children aged 15 months to 18 years.
  • May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past.

The study will be conducted in the United States, Puerto Rico, and other countries.

Participants will be assigned to 1 of 3 groups based on age:

Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants)

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

Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up).

At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1200

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

  • 波多黎各
      • Caguas、波多黎各、00725
        • 招聘中
        • Caguas Clinical Research LLC
      • Ponce、波多黎各、00716
        • 招聘中
        • Ponce Medical School Foundation Inc. / CAIMED Center
      • San Juan、波多黎各、00907-1509
        • 招聘中
        • BRCR Global Puerto Rico
      • San Juan、波多黎各、00918
        • 招聘中
        • CMRC Headlands, LLC
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • 招聘中
        • UAB Child Health Research Unit (CHRU)
      • Birmingham、Alabama、美国、35205
        • 招聘中
        • Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
      • Guntersville、Alabama、美国、35976
        • 招聘中
        • Lakeview Clinical Research, LLC
    • California
      • Fair Oaks、California、美国、95628
        • 招聘中
        • Apex Research Group
      • Ontario、California、美国、91762
        • 招聘中
        • Orange County Research Institute
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • Children's Hospital Colorado
    • Florida
      • Miami Lakes、Florida、美国、33016
        • 招聘中
        • Indago Research & Health Center, Inc
      • Miami Lakes、Florida、美国、33014
        • 招聘中
        • Riveldi and Associates
      • Tampa、Florida、美国、33617
        • 尚未招聘
        • Children's Health Center
    • Idaho
      • Ammon、Idaho、美国、83406
        • 招聘中
        • Medical Research Partners
      • Blackfoot、Idaho、美国、83221
        • 招聘中
        • Bingham Memorial Hospital
      • Boise、Idaho、美国、83702
        • 招聘中
        • ASR, LLC
    • Kentucky
      • Bardstown、Kentucky、美国、40004
        • 招聘中
        • Kentucky Pediatric/ Adult Research
    • Louisiana
      • Covington、Louisiana、美国、70433
        • 招聘中
        • Avacare
      • Lafayette、Louisiana、美国、70508
        • 招聘中
        • Velocity Clinical Research, Lafayette
      • Shreveport、Louisiana、美国、71101
        • 招聘中
        • LSU Health Shreveport Clinical Trials Office
      • Shreveport、Louisiana、美国、71101
        • 招聘中
        • Ochsner/LSU Health Shreveport - Progressive Pediatrics
      • Shreveport、Louisiana、美国、71103
        • 招聘中
        • Ochsner LSU Health Shreveport Ambulatory Care Center
      • Shreveport、Louisiana、美国、71103
        • 招聘中
        • Ochsner/LSU Health Shreveport Academic Medical Center
    • Massachusetts
      • Fall River、Massachusetts、美国、02721
        • 招聘中
        • Pediatric Associates of Fall River
    • Michigan
      • Bingham Farms、Michigan、美国、48025
        • 招聘中
        • Michigan Center of Medical Research
    • Minnesota
      • Minneapolis、Minnesota、美国、55402
        • 招聘中
        • Clinical Research Institute, Inc.
    • Nebraska
      • Lincoln、Nebraska、美国、68504
        • 招聘中
        • Midwest Children's Health Research Institute
      • Lincoln、Nebraska、美国、68505
        • 招聘中
        • Midwest Children's Health Research Institute
      • Lincoln、Nebraska、美国、68516
        • 招聘中
        • Midwest Children's Health Research Institute
      • Lincoln、Nebraska、美国、68522
        • 招聘中
        • Midwest Children's Health Research Institute
    • New York
      • East Syracuse、New York、美国、13057
        • 招聘中
        • Child Health Care Associates
      • Horseheads、New York、美国、14845
        • 招聘中
        • Corning Center for Clinical Research
      • Rochester、New York、美国、14642
        • 招聘中
        • University of Rochester Medical Center
    • Ohio
      • Cincinnati、Ohio、美国、45245
        • 招聘中
        • Pediatric Associates of Mt. Carmel
      • Cincinnati、Ohio、美国、45206
        • 招聘中
        • Cincinnati Children's Hospital Medical Center Investigational Drug Services
      • Cincinnati、Ohio、美国、45206
        • 招聘中
        • Cincinnati Children's Hospital Medical Center Vaccine Research Center
      • Dayton、Ohio、美国、45409
        • 招聘中
        • Dayton Clinical Research
      • South Euclid、Ohio、美国、44121
        • 招聘中
        • Senders Pediatrics
    • South Carolina
      • Simpsonville、South Carolina、美国、29681
        • 招聘中
        • Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
    • Tennessee
      • Tullahoma、Tennessee、美国、37388
        • 招聘中
        • Pediatric Clinical Trials of Tennessee, LLC
    • Texas
      • Corpus Christi、Texas、美国、78411
        • 招聘中
        • Driscoll Children's Hosptial
      • Houston、Texas、美国、77065
        • 招聘中
        • Kool Kids Pediatrics
      • Houston、Texas、美国、77054
        • 招聘中
        • Mercury Clinical Research (Administrative Office)
      • Houston、Texas、美国、77077
        • 招聘中
        • Mercury Clinical Research - Sunrise Pediatrics
      • Houston、Texas、美国、77402
        • 招聘中
        • Neutra Life Sciences
      • Houston、Texas、美国、77054
        • 招聘中
        • Mercury Clinical Research - Administrative Office
      • Houston、Texas、美国、77074
        • 尚未招聘
        • RTX Clinical Research
      • Houston、Texas、美国、77087
        • 招聘中
        • Mercury Clinical Research - MD Kids Pediatrics
      • League City、Texas、美国、77573
        • 招聘中
        • University of Texas Medical Branch,
      • Lewisville、Texas、美国、75067
        • 尚未招聘
        • Prime Clinical Research Inc.
      • Mansfield、Texas、美国、76063
        • 尚未招聘
        • Prime Clinical Research Inc.
      • Richmond、Texas、美国、77469
        • 招聘中
        • Pediatric Center- Neutra Life Sciences
      • San Antonio、Texas、美国、78215
        • 招聘中
        • Sun Research Institute
      • Victoria、Texas、美国、77901
        • 招聘中
        • Victoria Clinical Research Group
    • Utah
      • Layton、Utah、美国、84041
        • 招聘中
        • Tanner Clinic
      • Layton、Utah、美国、84041
        • 招聘中
        • Tanner Clinic - Layton Parkway
      • Provo、Utah、美国、84604
        • 招聘中
        • AMR Clinical
      • Syracuse、Utah、美国、84075
        • 招聘中
        • AMR Clinical
      • West Jordan、Utah、美国、84088
        • 招聘中
        • Velocity Clinical Research, Salt Lake City
    • Virginia
      • Charlottesville、Virginia、美国、22902
        • 招聘中
        • Pediatric Research of Charlottesville, LLC
      • Richmond、Virginia、美国、23226
        • 招聘中
        • 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

  • 孩子

接受健康志愿者

是的

描述

Inclusion Criteria:

Cohort 1 (Participants ≥15 Months to <2 Years of Age) Healthy toddlers and children ≥15 months to <2 years of age with documentation of prior receipt of PCV.

Cohort 2 (Participants ≥2 Years to <5 Years of Age) Healthy toddlers and children ≥2 years to <5 years of age with documentation of prior receipt of PCV if applicable.

Cohort 3 (Participants ≥5 Years to <18 Years of Age) Healthy children ≥5 years to <18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.

Exclusion Criteria:

All Cohorts (Participants ≥15 Months to <18 Years of Age)

Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment 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
有源比较器：20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
生物：20价肺炎球菌结合疫苗（20vPnC）
20价肺炎球菌结合疫苗（20vPnC）
其他名称：
  • 普雷夫纳尔 20
实验性的：PG4 (intramuscular)
Multivalent Pneumococcal vaccine
生物：PG4
Multivalent Pneumococcal Vaccine

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
大体时间：Within 7 days after Vaccination
Within 7 days after Vaccination
Percentage of Participants With Systemic Events Within 7 Days after Vaccination
大体时间：Within 7 days after Vaccination
Within 7 days after Vaccination
Percentage of Participants With Adverse Events (AEs)
大体时间：From Vaccination to 1 month after 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
From Vaccination to 6 months after Vaccination
GMCs of serotype-specific IgG concentrations
大体时间：1 month after vaccination
1 month after vaccination
GMTs of serotype-specific OPA titers
大体时间：1 month after vaccination
1 month after vaccination

次要结果测量

结果测量
大体时间
Percentage of participants with predefined serotype-specific IgG concentrations
大体时间：1 month after vaccination
1 month after vaccination
IgG GMFRs
大体时间：1 month after vaccination
1 month after vaccination
Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers
大体时间：before to 1 month after vaccination
before to 1 month after vaccination
OPA GMFRs
大体时间：before to 1 month after vaccination
before 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 (实际的)

2026年6月15日

初级完成 (估计的)

2027年12月2日

研究完成 (估计的)

2027年12月2日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月22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27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

  • C4931004
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523445-10-00 (注册表标识符：CTIS (EU))

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

在美国制造并从美国出口的产品

是的

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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