Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia coli Disease in Adults Aged 60 Years And Older with a History of Urinary Tract Infection in the Past 2 Years - E.mbrace (ICON #2786/0197)

Janssen Vaccines & Prevention B.V0 个研究点目标入组 1,600 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方: Janssen Vaccines & Prevention B.V
入组人数: 1,600

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•-Participant must be >=60 years of age on the day of signing the ICF and is
•expected to be available for the duration of the study, with no current
•intention of moving away from a study site area or travelling for periods
•longer than 30 consecutive days during the course of the study. -Participant
•must have a history of UTI in the past 2 years for which evidence of diagnosis
•was verified by the investigator. In case of a recent history of UTI or ABP
•(acute bacterial prostatitis), the condition must have resolved >14 days prior
•to randomization. -Participant must be medically stable at the time of
•vaccination such that, according to the judgment of the investigator,
•hospitalization within the study period is not anticipated and the participant
•appears likely to be able to remain on study through the end of
•protocol-specified follow-up. A stable medical condition is defined as disease
•not requiring significant change in therapy during the 6 weeks before
•enrollment and when hospitalization for worsening of the disease is not
•anticipated. Participants will be included on the basis of physical
•examination, medical history, and vital signs performed between ICF signature
•and vaccination. -Before randomization, participants who were born female must
•be either (as defined in Section 10.5, Appendix 5, Contraceptive Guidance and
•Collection of Pregnancy Information): a. postmenopausal or permanently sterile,
•and b. not intending to conceive by any methods. -Participant must be willing
•to provide verifiable identification, has means to be contacted and to contact
•the investigator during the study. -Participant and his/her designated
•caregiver (if applicable) must be able to read, understand, and complete
•questionnaires in the electronic clinical outcome assessment system (eCOA, ie,
•the electronic patient-reported outcomes [ePROs] and the eDiary). If the
•participant and caregiver are unable/unwilling to work with the eCOA system to
•complete the ePROs, participant or caregiver must agree to be available to be
•contacted by the site to complete all eCOA activities (ePROs) via site-assisted
•interview at the timepoints specified in the protocol. Participants in the
•Safety Subset must be willing and able to work with the eCOA system to complete
•the eDiary.
•-Participant must have at least one additional risk factor for invasive
•extraintestinal pathogenic Escherichia coli disease (IED), beyond a history of
•urinary tract infection (UTI) in the past 2 years. Additional risk factors for
•IED are defined as one or more of the following:
•a. a history of urosepsis and/or E. coli bacteremia at any time prior to
•randomization, and/or
•b. a history of inpatient hospitalization (for a medical/surgical cause) in the
•two years prior to randomization, and/or
•c. presence at baseline of at least one risk factor for complicated UTI of any
•toxicity grade.

排除标准

•-Participant has a serious chronic disorder or significant cognitive impairment
•for which, in the opinion of the investigator, participation would not be in
•the best interest of the participant (eg, compromise well-being) or that could
•prevent, limit, or confound the protocolspecified assessments. - Participant
•has end-stage renal disease for which dialysis is required.
•- Participant has a history of malignancy within 5 years before screening that
•does not include the following categories: (a) Participants with curatively
•treated squamous and basal cell carcinomas of the skin and carcinoma in situ of
•the cervix may be enrolled at the discretion of the investigator; (b)
•Participants with a diagnosis of localized prostate cancer may be enrolled at
•the discretion of the investigator if they completed treatment, or, if they
•remain under observation or active surveillance; Participants who underwent
•radical prostatectomy or radiotherapy may be enrolled at the discretion of the
•investigator if treatment has been completed 6 months prior to the planned
•administration of the study vaccine (c) Participants with a history of other
•malignancy within 5 years, which is considered adequately treated with minimal
•risk of recurrence per the investigator's judgment, may be enrolled. -
•Participant has a known history of severe allergic reaction, anaphylaxis or
•other serious adverse reactions to vaccines or vaccine excipients (including
•specifically the excipients of the study vaccine; refer to IB).
•- Abnormal function of the immune system resulting from: a. Clinical conditions
•or their treatments expected to have an impact on the immune response elicited
•by the study vaccine. b. Chronic or recurrent use of systemic corticosteroids
•within 3 months before administration of study vaccine and during the study. A
•substantially immunosuppressive steroid dose is considered to be >=2 weeks of
•daily receipt of 20 mg or more of prednisone or equivalent. c. Administration
•of antineoplastic and immunomodulating agents or radiotherapy expected to have
•an impact on the immune response elicited by the study vaccine within 6 months
•before administration of study vaccine and during the study. - Participant has
•a history of acute polyneuropathy (eg, Guillain-Barre* syndrome) or chronic
•inflammatory demyelinating polyneuropathy - Participant has received any E.
•coli or ExPEC vaccine. - Participant has received a hematopoietic stem cell
•transplant based on medical history, treatment with immunoglobulins within 2
•months, apheresis therapies within 4 months, or blood products within 3 months
•prior to the planned administration of the study vaccine or has any plans to
•receive such treatment during the study. - Participant has received or plans to
•receive: (a) licensed live attenuated vaccines - within 28 days before or after
•planned administration of the study vaccination; (b) other licensed (not live)
•vaccines - within 14 days before or after planned administration of the study
•vaccination; (c) vaccination with a vaccine authorized for Emergency Use
•Authorization, conditional Marketing Authorisation or a similar program is
•permitted when given at least 28 days before or after planned administration of
•the study vaccination. - Participant has had major surgery (per the
•investigator's judgment) wit

研究者

发起方

Janssen Vaccines & Prevention B.V

相似试验

招募中

3 期

A Study of Vaccination with 9-valent Extraintestinal Pathogenic Escherichia coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia coli Disease in Adults Aged 60 Years And Older with a History of Urinary Tract Infection in the Past 2 YearsInvasive extraintestinal pathogenic Escherichia coli disease (IED) preventionprevention

JPRN-jRCT2031210272akano Masayoshi18,556

尚未招募

3 期

A Global Study to find out the Effects of a Test Vaccine on prevention of harmful diseases caused by E.Coli spreading outside of the gut in Adults who are 60 Years And Older with a History of Urinary Tract Infection in the Past 2 Years.

CTRI/2023/11/059617Janssen Vaccines & Prevention B.V.

已完成

3 期

A study to assess effectiveness and safety of Insulin inhalation powder as compared to placebo inhalation powder in patients with type 2 Diabetes Mellitus.

CTRI/2020/09/027550Cipla Ltd216

招募中

1 期

A study to evaluate ExPEC9V vaccine for the prevention of Invasive E. coli Disease in adults aged 60 years and older with a history of urinary tract infection in the past two years.Invasive Extraintestinal Pathogenic Escherichia coli DiseaseMedDRA version: 20.0Level: HLTClassification code: 10015295Term: Escherichia infections Class: 10021881MedDRA version: 21.1Level: PTClassification code: 10052238Term: Escherichia urinary tract infection Class: 100000004862

CTIS2023-506589-30-00Janssen Vaccines & Prevention B.V.18,556

已完成

2 期

RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (REFRESH)

CTRI/2012/08/002944Reviva Pharmaceuticals Inc228