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A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF

2026年8月13日 更新者：Pfizer

A PHASE 3 STUDY IN INDIA TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS

The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.

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)

540

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

  • 印度
    • Andhra Pradesh
      • Visakhapatnam、Andhra Pradesh、印度、530002
        • 招聘中
        • King George Hospital
    • Karnataka
      • Bangalore、Karnataka、印度、560060
        • 招聘中
        • BGS Global Institute of Medical Sciences (BGSGIMS)
      • Bangalore、Karnataka、印度、560085
        • 招聘中
        • Radhakrishna Multispeciality Hospital and IVF Center
      • Belagavi、Karnataka、印度、590001
        • 招聘中
        • Belagavi Institute of Medical Sciences - Belagavi
    • Maharashtra
      • Nashik、Maharashtra、印度、422003
        • 招聘中
        • Suyog Hospital
    • National Capital Territory of Delhi
      • Dwarka、National Capital Territory of Delhi、印度、110075
        • 招聘中
        • Aakash Healthcare Private Limited
      • New Delhi、National Capital Territory of Delhi、印度、110029
        • 招聘中
        • All India Institute of Medical Sciences
      • New Delhi、National Capital Territory of Delhi、印度、110060
        • 招聘中
        • Sir Ganga Ram Hospital
    • Rajasthan
      • Jaipur、Rajasthan、印度、302039
        • 招聘中
        • Maharaja Agrasen Superspeciality Hospital
    • Tamil Nadu
      • Chengalpattu、Tamil Nadu、印度、603203
        • 招聘中
        • SRM Medical College Hospital and Research Centre - Kattankulathur
      • Kelambākkam、Tamil Nadu、印度、603103
        • 招聘中
        • Chettinad Hospital and Research Institute
    • West Bengal
      • Kolkata、West Bengal、印度、700020
        • 招聘中
        • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
      • Kolkata、West Bengal、印度、700020
        • 招聘中
        • Institute of Post Graduate Medical Education & Research, SSKM Hospital

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
  • 年长者

接受健康志愿者

是的

描述

Key Inclusion Criteria:

  • Participants ≥18 years of age at Visit 1.
  • Participants who are ambulatory and live independently in the community.
  • Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Applicable to participants 18 through 59 years of age: Participants who are healthy or have stable preexisting diseases. These participants are considered at high risk of RSV disease by having at least 1 reportable stable chronic medical condition(s) that belongs to 1 or more of the following:
  • Chronic heart disease (ie, coronary artery disease, heart failure, or congenital heart disease)
  • Chronic lung disease (ie, COPD, emphysema, asthma, interstitial lung disease, or cystic fibrosis)
  • Nongestational diabetes mellitus type 1 or type 2
  • Severe obesity (body mass index [BMI] ≥40 kg/m2)
  • Chronic liver disease (ie, cirrhosis)
  • Chronic kidney disease (not including end-stage renal disease with or without dialysis)
  • Chronic neurological disease that causes impaired airway clearance or respiratory muscle weakness (ie, poststroke dysphagia, amyotrophic lateral sclerosis, or muscular dystrophy)
  • Chronic hematologic disease (ie, sickle cell disease or thalassemia)

Note: A chronic medical condition for this study is defined as:

  • Duration ≥6 months.
  • Requires regular medical follow-up or ongoing prescribed medication or hospitalization in the previous year.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.

Key Exclusion Criteria:

  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
  • Prior history of any subtype of Guillain-Barré syndrome of any etiology.
  • Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  • Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study.

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：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
生物：安慰剂
安慰剂
实验性的：RSVpreF
RSVpreF Vaccine
生物：RSVpreF
RSVpreF Vaccine

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
报告不良事件（AEs）的参与者百分比（截至研究性产品给药后1个月）
大体时间：接种疫苗后1个月
描述在试验产品给药后1个月内发生的不良事件
接种疫苗后1个月
Proportion of participants reporting local reactions within 7 days following investigational product administration
大体时间：Within 7 days
Describe local reactions following investigational product administration
Within 7 days
Percentage of participants reporting systemic events within 7 days following investigational product administration
大体时间：Within 7 days
Describe systemic events following investigational product administration
Within 7 days
Percentage of participants reporting serious adverse events (SAEs) throughout the study
大体时间：3 months after vaccination
Describe SAEs through 3 months following administration of investigational product
3 months after vaccination
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
大体时间：Before vaccination, 1 month after vaccination
Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
大体时间：Before vaccination, 1 month after vaccination
Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as seroresponse rate
大体时间：1 month after vaccination
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22日

初级完成 (估计的)

2027年1月25日

研究完成 (估计的)

2027年1月25日

研究注册日期

首次提交

2026年6月11日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月13日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • C3671040

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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