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
- Conditions
- urinary tract infection10004018
- Registration Number
- NL-OMON56258
- Lead Sponsor
- Janssen Vaccines & Prevention B.V
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1600
-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.
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method