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2月龄及以上健康婴儿21价肺炎球菌结合疫苗批间一致性研究

2026年10月1日 更新者：Sanofi

一项针对健康婴幼儿的21价肺炎球菌结合疫苗4剂接种方案的3期、随机、改良双盲、活性对照、平行组、批次间一致性、四臂研究，旨在评估其安全性和免疫原性

This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).

The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.

There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days

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)

2195

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

  • 姓名：Trial Transparency email recommended (Toll free for US & Canada)
  • 电话号码：option 6 800-633-1610
  • 邮箱：Contact-US@sanofi.com

学习地点

  • 波多黎各
      • Guayama、波多黎各、00786
        • 招聘中
        • Investigational Site Number : 6300005
      • San Juan、波多黎各、00918
        • 招聘中
        • Investigational Site Number : 6300006
      • Trujillo Alto、波多黎各、00976
        • 招聘中
        • Investigational Site Number : 6300007
  • 泰国
      • Bangkok、泰国、10400
        • 招聘中
        • Investigational Site Number : 7640002
      • Chiang Mai、泰国、50180
        • 招聘中
        • Investigational Site Number : 7640004
      • Hat Yai、泰国、90110
        • 招聘中
        • Investigational Site Number : 7640003
      • Khon Kaen、泰国、40002
        • 招聘中
        • Investigational Site Number : 7640001
      • Pathum Wan、泰国、10330
        • 招聘中
        • Investigational Site Number : 7640005
  • 洪都拉斯
      • San Pedro Sula、洪都拉斯、21104
        • 招聘中
        • Investigational Site Number : 3400001
      • Tegucigalpa、洪都拉斯、11101
        • 招聘中
        • Investigational Site Number : 3400003
      • Tegucigalpa、洪都拉斯、11101
        • 招聘中
        • Investigational Site Number : 3400002
  • 美国
    • Arkansas
      • Fayetteville、Arkansas、美国、72703
        • 招聘中
        • Northwest Arkansas Pediatric Clinic- Site Number : 8400039
    • California
      • Huntington Park、California、美国、90255
        • 招聘中
        • Matrix Clinical Research - Huntington Park- Site Number : 8400029
      • Los Angeles、California、美国、90008
        • 招聘中
        • Community Clinical Research- Site Number : 8400030
      • Los Angeles、California、美国、90057
        • 招聘中
        • Matrix Clinical Research - Los Angeles- Site Number : 8400028
    • Florida
      • Tampa、Florida、美国、33613
        • 招聘中
        • PAS Research - Tampa- Site Number : 8400034
    • Kentucky
      • Bardstown、Kentucky、美国、40004
        • 招聘中
        • Kentucky Pediatric Research- Site Number : 8400036
    • Michigan
      • Allen Park、Michigan、美国、48101
        • 招聘中
        • Michigan Institute of Research- Site Number : 8400004
    • New York
      • Syracuse、New York、美国、13210
        • 招聘中
        • Nappi Wellness Institute\t- Site Number : 8400037
    • South Carolina
      • Charleston、South Carolina、美国、29407
        • 招聘中
        • Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008
      • Simpsonville、South Carolina、美国、29681
        • 招聘中
        • Parkside Pediatrics - Simpsonville- Site Number : 8400005
      • Spartanburg、South Carolina、美国、29301
        • 招聘中
        • Tribe Clinical Research - Spartanburg- Site Number : 8400026
    • Texas
      • Edinburg、Texas、美国、78539
        • 招聘中
        • PAS Research - Children's Care Clinic- Site Number : 8400035
      • Richmond、Texas、美国、77469
        • 招聘中
        • Pediatric Center - Richmond- Site Number : 8400038
    • Utah
      • Ogden、Utah、美国、84404
        • 招聘中
        • Rio Clinical Trials - Canyon View- Site Number : 8400031

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

1个月 至 2个月 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Aged 42 to 89 days on the day of inclusion
  • Participants who are healthy as determined by medical evaluation including medical history and physical examination
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable

Exclusion Criteria:

  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
  • History of microbiologically confirmed Streptococcus pneumoniae infection or disease
  • Any contraindication to the routine pediatric vaccine being administered in the study
  • History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
  • Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3
  • Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration.
  • Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
  • Previous vaccination against Streptococcus pneumoniae
  • Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus
  • Receipt of more than 1 dose of hepatitis B vaccine
  • Receipt of immune globulins, blood or blood-derived products since birth
  • Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical 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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Group 1: PCV21

Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
生物：PCV21 vaccine

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

其他名称：
  • 515
实验性的：Group 2: PCV21

Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
生物：PCV21 vaccine

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

其他名称：
  • 515
实验性的：Group 3: PCV21

Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
生物：PCV21 vaccine

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

其他名称：
  • 515
有源比较器：Group 4: 20vPCV (Cohort A only)

Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
生物：20vPCV licensed vaccine

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

其他名称：
  • Prevnar 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
For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
大体时间：30 days after the third dose of PCV21 vaccine

Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL)
30 days after the third dose of PCV21 vaccine

次要结果测量

结果测量
措施说明
大体时间
For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL
大体时间：30 days after the third dose of PCV21 vaccine

Serotype specific IgG concentration ≥ 0.35 μg/mL (seroresponse) for all serotypes included in PCV21 as measured by ECL
30 days after the third dose of PCV21 vaccine
For all participants: Presence of any immediate adverse events (AEs)
大体时间：Within 30 minutes after each vaccine injection

Number of participants experiencing immediate AEs
Within 30 minutes after each vaccine injection
For participants in Cohort A (reactogenicity subset): Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
大体时间：Through 7 days after each vaccine injection

Number of participants experiencing solicited injection site and systemic reactions
Through 7 days after each vaccine injection
For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs
大体时间：Through 30 days after each vaccine injection

Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Through 30 days after each vaccine injection
For all participants: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
大体时间：Throughout the study (through 6 months post-last vaccine injection)

Number of participants experiencing SAEs and AESIs
Throughout the study (through 6 months post-last vaccine injection)

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

Sanofi

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1月20日

初级完成 (估计的)

2027年6月7日

研究完成 (估计的)

2028年5月29日

研究注册日期

首次提交

2026年1月15日

首先提交符合 QC 标准的

2026年1月15日

首次发布 (实际的)

2026年1月16日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年10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

  • PSK00029
  • PSK00029 (其他标识符：Sanofi Identifier)
  • U1111-1308-6832 (其他标识符：WHO ICTRP)

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

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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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