E.mbrace
Research type
Research Study
Full title
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.
IRAS ID
1003626
Contact email
Sponsor organisation
Janssen Vaccines & Prevention B.V
Eudract number
2020-005273-27
Clinicaltrials.gov Identifier
Research summary
This study is a multicentre study to assess safety, efficacy and immunogenicity of vaccination with ExPEC9V in the prevention of Invasive Extraintestinal Pathogenic Escherichia coli Disease (IED) in adults aged 60 years and older with a history of urinary tract infection in the past 2 years. Approximately 18, 556 participants will take part in this study. Participants will either be vaccinated with ExPEC9V or placebo in a 1:1 ratio (50% chance of receiving ExPEC9V or placebo). Each part of the study consists of screening, randomisation, and vaccination for each participant on Day 1. Each participant will be followed for a maximum of approximately 36 months (1,096 days; 3 years) post-vaccination.
During the study participants will undergo a series of assessments including but not limited to physical examinations, vital sign measurements, answering questions on an electronic device, blood and urine sampling.
The main purpose of this study is to find out if the ExPEC9V study vaccine can protect adults 60 years and older against IED.
Participants may be invited to take part in different subsets, which includes immunogenicity subset, safety subset and safety and immunogenicity subset.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0155
Date of REC Opinion
18 Aug 2021
REC opinion
Further Information Favourable Opinion