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A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.

2026年9月4日 更新者：Pfizer

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

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 infants 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 when given with other childhood vaccines.

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 infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.

There are three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are:

  • infants who are 2 months of age in Group 1;
  • infants who are 2 to 6 months of age in Groups 2 and 3; and
  • said to be healthy by the study doctor

About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age.

About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.

About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.

Infants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. Infants will have 3 blood samples collected.

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)

3230

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

  • 日本
      • Fukui、日本、910-0833
        • 招聘中
        • Fukui Aiiku Hospital
      • Fukuoka、日本、813-0036
        • 招聘中
        • Fukazawa Pediatric Clinic
      • Osaka、日本、544-0033
        • 招聘中
        • Kubota Children's Clinic
    • Aichi-ken
      • Toyota-shi、Aichi-ken、日本、471-8513
        • 招聘中
        • Toyota Memorial Hospital
    • Fukuoka
      • Fukuoka、Fukuoka、日本、814-0121
        • 招聘中
        • Shindo children's clinic
      • Kasuga、Fukuoka、日本、816-0801
        • 招聘中
        • Yokoyama Children'S Clinic
    • Hokkaido
      • Sapporo、Hokkaido、日本、062-0907
        • 招聘中
        • Ohigesenseino Kodomo Clinic
    • Kagoshima-ken
      • Hioki、Kagoshima-ken、日本、899-2503
        • 招聘中
        • Nintenkaikagoshima Children's Hospital
    • Tokyo
      • Shinjuku-ku、Tokyo、日本、160-0017
        • 招聘中
        • Futaba Clinic
    • Yamanashi
      • Kofu、Yamanashi、日本、400-0853
        • 招聘中
        • Kose Children Clinic
  • 波多黎各
      • Bayamón、波多黎各、00960
        • 招聘中
        • Clinical Research Investigator Group
      • Caguas、波多黎各、00726
        • 招聘中
        • San Juan Bautista School of Medicine - Clinical Research Unit
      • Caguas、波多黎各、00725
        • 招聘中
        • Caguas Clinical Research
      • Guayama、波多黎各、00784
        • 招聘中
        • Clinical Research Puerto Rico
      • Ponce、波多黎各、00716
        • 招聘中
        • Ponce Medical School Foundation Inc./ CAIMED Center
      • Ponce、波多黎各、00728
        • 招聘中
        • BRCR Global Puerto Rico
      • San Juan、波多黎各、00907
        • 招聘中
        • BRCR Global Puerto Rico
      • Trujillo Alto、波多黎各、00976-3910
        • 招聘中
        • San Miguel Medical
  • 美国
    • Alabama
      • Bessemer、Alabama、美国、35022
        • 尚未招聘
        • Kur Research, LLC
      • Birmingham、Alabama、美国、35233
        • 招聘中
        • University of Alabama at Birmingham - School of Medicine
      • Birmingham、Alabama、美国、35205
        • 招聘中
        • Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
      • Centreville、Alabama、美国、35042
        • 尚未招聘
        • Kur Research, LLC
    • Arkansas
      • Fayetteville、Arkansas、美国、72703
        • 招聘中
        • Northwest Arkansas Pediatric Clinic
      • Jonesboro、Arkansas、美国、72401
        • 招聘中
        • The Children's Clinic of Jonesboro, P.A.
      • Sherwood、Arkansas、美国、72120
        • 招聘中
        • Helios Clinical Research
    • California
      • Anaheim、California、美国、92805
        • 招聘中
        • Advanced Research Center, Inc.
      • Arcadia、California、美国、91007
        • 招聘中
        • San Gabriel Woman's Health
      • Bellflower、California、美国、90706
        • 招聘中
        • Coast Clinical Research, LLC
      • El Monte、California、美国、91731
        • 招聘中
        • Family Medical Clinic
      • Fresno、California、美国、93704
        • 招聘中
        • Clinical Research of Central California
      • Montebello、California、美国、90640
        • 招聘中
        • SeraCollection Research Services, LLC
      • National City、California、美国、91950
        • 招聘中
        • Bailony Pediatrics
      • Palo Alto、California、美国、94304
        • 尚未招聘
        • Stanford University Medical Center
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • Childrens Hospital of Colorado
    • Florida
      • Hialeah、Florida、美国、33012
        • 招聘中
        • Direct Helpers Research Center
      • Homestead、Florida、美国、33030
        • 招聘中
        • C & R Research Services USA
      • Miami、Florida、美国、33155
        • 招聘中
        • Gold Coast Health Research Center, LLC
      • Miami、Florida、美国、33155
        • 招聘中
        • Bioresearch Partner
      • Miami、Florida、美国、33143
        • 招聘中
        • Florida Pharmaceutical Research and Associates, Inc.
      • Miami、Florida、美国、33173
        • 招聘中
        • Dade Research Center
      • Miami、Florida、美国、33183
        • 招聘中
        • Vasconcello-Cohen MD Research, LLC.
      • Miami Lakes、Florida、美国、33014
        • 招聘中
        • Riveldi and Associates
      • North Lauderdale、Florida、美国、33068
        • 招聘中
        • Eminent Clinical Research and Associates
      • Sweetwater、Florida、美国、33182
        • 招聘中
        • Cordova Research Institute LLC
      • Tampa、Florida、美国、33617
        • 招聘中
        • Children's Health Center
    • Georgia
      • Chamblee、Georgia、美国、30341
        • 尚未招聘
        • ObjectiveHealth Clinical Research LLC - Chamblee
      • Norcross、Georgia、美国、30093
        • 招聘中
        • Altruistic Clinical Research Global
    • 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
      • Idaho Falls、Idaho、美国、83404
        • 招聘中
        • Leavitt Clinical Research
    • Illinois
      • Moline、Illinois、美国、61265
        • 招聘中
        • MidValley Research, Inc
    • Iowa
      • Ankeny、Iowa、美国、50023
        • 招聘中
        • The Iowa Clinic.
      • West Des Moines、Iowa、美国、50265
        • 招聘中
        • Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
    • Kansas
      • Derby、Kansas、美国、67037
        • 招聘中
        • Integrity Clinical Network, LLC
    • Louisiana
      • Haughton、Louisiana、美国、71037
        • 招聘中
        • ACC Pediatric Research
    • Maryland
      • Baltimore、Maryland、美国、21201
        • 尚未招聘
        • University of Maryland, Baltimore, Center for Vaccine Development and Global Health
      • Columbia、Maryland、美国、21045
        • 尚未招聘
        • The Pediatric Center
      • Columbia、Maryland、美国、21045
        • 招聘中
        • Kur Research, LLC
    • Michigan
      • Allen Park、Michigan、美国、48101
        • 招聘中
        • Michigan Institute of Research
      • Bingham Farms、Michigan、美国、48025
        • 招聘中
        • Michigan Center of Medical Research
      • Dearborn Heights、Michigan、美国、48127
        • 招聘中
        • Vida Clinical Studies, LLC
    • Missouri
      • Columbia、Missouri、美国、65212
        • 招聘中
        • University of Missouri
      • Columbia、Missouri、美国、65201
        • 招聘中
        • University of Missouri Pediatrics Clinic-South Providence
    • Nebraska
      • Grand Island、Nebraska、美国、68803
        • 招聘中
        • Velocity Clinical Research, Grand Island
      • 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
      • Rochester、New York、美国、14642
        • 招聘中
        • University of Rochester Medical Center
    • North Carolina
      • Charlotte、North Carolina、美国、28203
        • 招聘中
        • Atrium Health Cannon Research Cente
      • Charlotte、North Carolina、美国、28207
        • 招聘中
        • Atrium Health - STRIVE Research clinic
      • Charlotte、North Carolina、美国、28207
        • 招聘中
        • Atrium Health Levine Children's Myers Park Pediatrics
      • Durham、North Carolina、美国、27703
        • 招聘中
        • Duke Vaccine and Trials Unit
      • Durham、North Carolina、美国、27704
        • 招聘中
        • Durham Pediatrics at North Duke Street
      • Matthews、North Carolina、美国、28105
        • 招聘中
        • Atrium Health Levine Children's Charlotte Pediatrics
      • Matthews、North Carolina、美国、28105
        • 招聘中
        • Atrium Health STRIVE Research Clinic - Matthews
      • Wilmington、North Carolina、美国、28405
        • 招聘中
        • Wilmington Health
    • Ohio
      • Cincinnati、Ohio、美国、45245
        • 招聘中
        • Pediatric Associates of Mt. Carmel
      • Dayton、Ohio、美国、45429
        • 招聘中
        • PriMed Clinical Research
      • South Euclid、Ohio、美国、44121
        • 招聘中
        • Senders Pediatrics
    • Pennsylvania
      • Bellevue、Pennsylvania、美国、15202
        • 招聘中
        • UPMC Children's Community Pediatrics- Bellevue
      • Cranberry Township、Pennsylvania、美国、16066
        • 招聘中
        • UPMC Children's Community Pediatrics Bass Wolfson-Cranberry
      • Erie、Pennsylvania、美国、16506
        • 招聘中
        • Allegheny Health and Wellness Pavilion
      • Jefferson Hills、Pennsylvania、美国、15025
        • 招聘中
        • UPMC Children's Community Pediatrics South Hills-Jefferson Hills
      • N. Huntingdon、Pennsylvania、美国、15642
        • 招聘中
        • UPMC Children's Community Pediatrics - Norwin
      • Pittsburgh、Pennsylvania、美国、15217
        • 招聘中
        • UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
      • Pittsburgh、Pennsylvania、美国、15234
        • 招聘中
        • UPMC Children's Community Pediatrics-Castle Shannon
      • Pittsburgh、Pennsylvania、美国、15213
        • 招聘中
        • UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland
      • Pittsburgh、Pennsylvania、美国、15227
        • 招聘中
        • UPMC Children's Community Pediatrics-Brentwood
    • South Carolina
      • Simpsonville、South Carolina、美国、29680
        • 招聘中
        • Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
      • Summerville、South Carolina、美国、29486
        • 招聘中
        • Carolina Family Care
      • Summerville、South Carolina、美国、29486
        • 招聘中
        • MUSC Children's Health
    • Tennessee
      • Memphis、Tennessee、美国、38105
        • 尚未招聘
        • Le Bonheur Children's Hospital - Outpatient Building
      • Tullahoma、Tennessee、美国、37388
        • 招聘中
        • Pediatric Clinical Trials of Tennessee, LLC
    • Texas
      • Brownsville、Texas、美国、78520
        • 招聘中
        • Proactive RGV
      • Corpus Christi、Texas、美国、78404
        • 尚未招聘
        • South Texas Clinical Research
      • Edinburg、Texas、美国、78539
        • 招聘中
        • Proactive Clinical Research LLC
      • El Paso、Texas、美国、79902
        • 招聘中
        • Proactive El Paso,LLC
      • Forney、Texas、美国、75126
        • 招聘中
        • SMS Clinical Research LLC.
      • Galveston、Texas、美国、77555
        • 招聘中
        • University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
      • Houston、Texas、美国、77065
        • 招聘中
        • Kool Kids Pediatrics
      • Houston、Texas、美国、77090
        • 招聘中
        • Houston Clinical Research Associates
      • 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、77042
        • 招聘中
        • Neutra Life Sciences
      • Houston、Texas、美国、77087
        • 招聘中
        • Mercury Clinical Research - MD Kids Pediatrics
      • Houston、Texas、美国、77057
        • 尚未招聘
        • UDL Clinical Research, LLC.
      • Houston、Texas、美国、77074
        • 招聘中
        • Aavon Clinical Trials, LLC.
      • Houston、Texas、美国、77074
        • 招聘中
        • RTX Clinical Research
      • Lewisville、Texas、美国、75067
        • 招聘中
        • Prime Clinical Research - Lewisville
      • Mansfield、Texas、美国、76063
        • 招聘中
        • Prime Clinical Research - Mansfield
      • McAllen、Texas、美国、78504
        • 招聘中
        • Dr. Ruben Aleman & Associates
      • Mesquite、Texas、美国、75149
        • 招聘中
        • SMS Clinical Research LLC
      • Mesquite、Texas、美国、75150
        • 招聘中
        • SMS Clinical Research LLC
      • 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
        • 尚未招聘
        • Crossroads Clinical Research
    • Utah
      • Provo、Utah、美国、84604
        • 招聘中
        • AMR Clinical
      • Syracuse、Utah、美国、84075
        • 招聘中
        • AMR Clinical
    • Virginia
      • Richmond、Virginia、美国、23226
        • 招聘中
        • Clinical Research Partners, LLC
      • Richmond、Virginia、美国、23233
        • 招聘中
        • Tekton Research, LLC.
    • Wisconsin
      • Marshfield、Wisconsin、美国、54449
        • 招聘中
        • Marshfield Medical Center - Marshfield

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:

  • infants who are 2 months of age in Group 1.
  • infants who are 2 to 6 months of age in Groups 2 and 3.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
  • Major known congenital malformation or serious chronic disorder.
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

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：Group 1 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
生物：PG4
Multivalent Pneumococcal Vaccine
有源比较器：Group 1 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：Group 2 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
生物：PG4
Multivalent Pneumococcal Vaccine
有源比较器：Group 2 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：Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
生物：PG4
Multivalent Pneumococcal Vaccine
实验性的：Group 3 PG4 (subcutaneous)
Multivalent Pneumococcal Vaccine
生物：PG4
Multivalent Pneumococcal Vaccine
有源比较器：Group 3 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

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
每次给药后 7 天内报告局部反应的参与者百分比
大体时间：第 7 天
每次给药后提示局部反应
第 7 天
报告严重不良事件 (SAE) 的参与者百分比
大体时间：第 4 剂后 1 至 6 个月服用
严重不良事件发生在第 4 剂注射后 1 至 6 个月
第 4 剂后 1 至 6 个月服用
Percentage of participants reporting systemic events within 7 days after each dose
大体时间：Day 7
Prompted systemic events after each dose
Day 7
Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3
大体时间：Dose 1 to 1 month after Dose 3
AEs occurring from Dose 1 to 1 month after Dose 3
Dose 1 to 1 month after Dose 3
Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4
大体时间：Dose 4 to 1 month after Dose 4
AEs occurring from Dose 4 to 1 month after Dose 4
Dose 4 to 1 month after Dose 4
Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3
大体时间：1 month after Dose 3
Differences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3
1 month after Dose 3
Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4
大体时间：1 month after Dose 4
Pneumococcal IgG GMCs 1 month after Dose 4
1 month after Dose 4

次要结果测量

结果测量
措施说明
大体时间
Pneumococcal IgG GMCs 1 month after Dose 3
大体时间：1 month after Dose 3
Pneumococcal IgG GMCs 1 month after Dose 3
1 month after Dose 3
Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3
大体时间：1 month after Dose 3
Pneumococcal serotype 3 IgG concentrations 1 month after Dose 3
1 month after Dose 3
Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4
大体时间：1 month after Dose 4
Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4
1 month after Dose 4
Differences in percentages of participants with predefined pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3
大体时间：1 month after Dose 3
Differences in pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3
1 month after Dose 3
Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4
大体时间：1 month after Dose 4
Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4
1 month after Dose 4
Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3
大体时间：1 month after Dose 3
Pneumococcal OPA titers 1 month after Dose 3
1 month after Dose 3
Pneumococcal OPA titers prior to Dose 4
大体时间：Prior to Dose 4
Pneumococcal OPA titers prior to Dose 4
Prior to Dose 4
Pneumococcal OPA titers 1 month after Dose 4
大体时间：1 month after Dose 4
Pneumococcal OPA titers 1 month after Dose 4
1 month after Dose 4
Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4
大体时间：1 month after Dose 4
Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4
1 month after Dose 4
Pneumococcal IgG concentrations 1 month after Dose 3
大体时间：1 month after Dose 3
Pneumococcal IgG concentrations 1 month after Dose 3
1 month after Dose 3
Pneumococcal IgG concentrations prior to Dose 4
大体时间：Prior to Dose 4
Pneumococcal IgG concentrations prior to Dose 4
Prior to Dose 4
Pneumococcal IgG concentrations 1 month after Dose 4
大体时间：1 month after Dose 4
Pneumococcal IgG concentrations 1 month after Dose 4
1 month after Dose 4
IgG geometric mean fold rise (GMFR) from before Dose 4 to 1 month after Dose 4
大体时间：Before Dose 4 to 1 month after Dose 4
IgG GMFR from before Dose 4 to 1 month after Dose 4
Before Dose 4 to 1 month after Dose 4
IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4
大体时间：From 1 month after Dose 3 to 1 month after Dose 4
IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4
From 1 month after Dose 3 to 1 month after Dose 4
Percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3
大体时间：1 month after Dose 3
Prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3
1 month after Dose 3
Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4
大体时间：1 month after Dose 4
Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4
1 month after Dose 4
Geometric mean of immunoglobulin A (IgA) antibody levels to rotavirus 1 month after Dose 3
大体时间：1 month after Dose 3
Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3
1 month after Dose 3

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5月29日

初级完成 (估计的)

2029年6月5日

研究完成 (估计的)

2029年6月5日

研究注册日期

首次提交

2026年5月27日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9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

  • C4931008

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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