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

Janssen Vaccines & Prevention B.V0 个研究点目标入组 18,556 人开始时间: 2021年6月23日最近更新: 2021年10月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Janssen Vaccines & Prevention B.V
入组人数: 18,556

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 clinical trial of medicinal product

入排标准

性别: All

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 that is documented in the medical records. In case of a recent history of UTI, 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 10.4, Appendix 4, 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 or his/her designated caregiver must be able to work with smartphones/tablets/computers.
•-Participant and his/her designated caregiver (if applicable) must be able to read, understand, and complete questionnaires in the eCOA (ie, the electronic patient-reported outcomes [ePROs] and the eDiary).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 3712
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14844

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 protocol-specified assessments.
•- Participant has end-stage renal disease for which dialysis is required.
•- Chronic use of antimicrobials. In case of prolonged antimicrobial treatment (>3 weeks) or chronic use of antimicrobials, the last dose must have been administered >60 days prior to randomization.
•- Participant has a history of malignancy within 5 years before screening not in the following categories:(a) Participants with 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 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; (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 allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine; refer to IB).
•- Abnormal function of the immune system resulting from:
•a. Clinical conditions (eg, autoimmune disease or immunodeficiency).
•b. Chronic or recurrent use of systemic corticosteroids
•c. Administration of antineoplastic and immunomodulating agents or radiotherapy.
•- Participant has a history of acute polyneuropathy (eg, Guillain-Barré 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 4 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 licensed or authorized for Emergency Use Authorization, conditional Marketing Authorisation or a similar program) COVID-19 vaccine 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) within 4 weeks before dosing or will not have recovered from surgery per the investigator’s judgment at time of vaccination.
•- Participant has chronic active hepatitis B or hepatitis C infection based on medical history. Note: participant may have stable HBV or HCV infection.
•- Participant has evidence of HIV type 1 or type 2 infection by medical history. Note: participant may have stable/well-controlled HIV.

研究者

发起方

Janssen Vaccines & Prevention B.V

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