問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberVAC52416BAC3001
NCT Number(ClinicalTrials.gov Identfier)NCT04899336
Active

2022-12-09 - 2029-06-30

Phase III

Not yet recruiting3

Recruiting1

ICD-10B96.20

Unspecified Escherichia coli [E. coli] as the cause of diseases classified elsewhere

ICD-10B96.21

Shiga toxin-producing Escherichia coli [E. coli] (STEC) O157 as the cause of diseases classified elsewhere

ICD-10B96.22

Other specified Shiga toxin-producing Escherichia coli [E. coli] (STEC) as the cause of diseases classified elsewhere

ICD-10B96.23

Unspecified Shiga toxin-producing Escherichia coli [E. coli] (STEC) as the cause of diseases classified elsewhere

ICD-10B96.29

Other Escherichia coli [E. coli] as the cause of diseases classified elsewhere

ICD-9041.4

Escherichia coli﹝E.coli﹞infections of unspeciied site

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

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Cheng-Hsun Chiu Division of Pediatrics
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 薛光傑 Division of Family Medicine
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yi-Ching Yang Division of Family Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Po-Yu Liu Division of Infectious Disease
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Objectives

he purpose of this trial is to demonstrate that the 9-valent parenteral pathogenic E. coli vaccine (ExPEC9V) is effective compared to placebo in preventing the first case of invasive parenteral pathogenic E. coli disease (IED) caused by ExPEC9V serotype O. ) event-wise efficacy.

Test Drug

ExPEC9V

Active Ingredient

VAC52416 (JNJ-78901563 [ExPEC9V])

Dosage Form

Solution for injection

Dosage

176

Endpoints

Main outcome measures
‧ First case of invasive parenteral pathogenic E. coli disease caused by 9-valent parenteral pathogenic E. coli vaccine (ExPEC9V) serotype O ( IED) Number of participants in the event
‧ Number of participants with first IED event caused by ExPEC9V serotype O using blood or other sterile site specimens for microbial confirmation

Inclution Criteria

Inclusion Criteria:

Participant must be willing to share relevant medical information pertaining to medical history and to share medical records relevant to the medical events identified as suspected cases of invasive extraintestinal pathogenic Escherichia coli disease (IED), urinary tract infections (UTI), or acute bacterial prostatitis (ABP) occurring during the study observation period
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, the condition must have resolved greater than (>)14 days prior to randomization
Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and 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

Exclusion Criteria

Exclusion Criteria:

Participant has end-stage renal disease for which dialysis is required
Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws
Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy
Participant has received any Escherichia coli (E. coli) or extraintestinal pathogenic Escherichia coli (ExPEC) vaccine

The Estimated Number of Participants

  • Taiwan

    500 participants

  • Global

    19800 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB