A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older

Last updated: April 24, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

ExPEC9V

HD quadrivalent influenza vaccine

Placebo

Clinical Study ID

NCT06134804
CR109338
2023-504168-40-00
VAC52416BAC3002
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be medically stable at the time of vaccination such that, according to thejudgment of the investigator, hospitalization within the study period is notanticipated and the participant appears likely to be able to remain on study throughthe end of protocol specified follow-up. A stable medical condition is defined asdisease not requiring significant change in therapy during the 6 weeks beforeenrollment 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 informed consent form (ICF) signature andvaccination

  • Participant must be: a) postmenopausal (postmenopausal state is defined as no mensesfor 12 months without an alternative medical cause); and b) not intending toconceive by any methods

  • Must sign an ICF indicating that the participant understands the purpose, proceduresand potential risks and benefits of the study, and is willing to participate in thestudy

  • Willing and able to adhere to the lifestyle restrictions specified in this protocol

  • Agrees to not donate blood from the time of vaccination until 3 months afterreceiving the last dose of study vaccine

Exclusion

Exclusion Criteria:

  • History of an underlying clinically significant acute or uncontrolled chronicmedical condition or significant cognitive impairment or physical examinationfindings for which, in the opinion of the investigator, participation would not bein the best interest of the participant (for example, compromise the well-being) orthat could prevent, limit, or confound the protocol-specified assessments

  • Known or suspected allergy or history of severe allergic reaction, anaphylaxis, orother serious adverse reactions to vaccines or vaccine excipients

  • History of severe allergic reactions (for example anaphylaxis) to any component ofthe high-dose (HD) quadrivalent seasonal influenza vaccine, including egg protein,or following a previous dose of any influenza vaccine

  • Has had major surgery (per the investigator's judgment) within 4 weeks beforeadministration of the first study vaccine or will not have recovered from surgeryper the investigator's judgment at time of vaccination

  • History of acute polyneuropathy (for example, Guillain-Barré syndrome) or chronicinflammatory demyelinating polyneuropathy

Study Design

Total Participants: 959
Treatment Group(s): 3
Primary Treatment: ExPEC9V
Phase: 3
Study Start date:
October 24, 2023
Estimated Completion Date:
July 26, 2024

Connect with a study center

  • Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV)

    Edegem, 2650
    Belgium

    Site Not Available

  • Center for Vaccinology (CEVAC)

    Gent, 9000
    Belgium

    Site Not Available

  • Az Sint-Maarten

    Mechelen, 2800
    Belgium

    Site Not Available

  • Aggarwal and associates Ltd

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • Milestone Research

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Centricity Research- Manna Research (MR) - Quebec Location

    Levis, Quebec G6W 0M5
    Canada

    Site Not Available

  • PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.

    Gdansk, 80405
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80 382
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Gdynia

    Gdynia, 81 537
    Poland

    Site Not Available

  • Synexus Polska Sp z o o Oddzial w Katowicach

    Katowice, 40 040
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, 40-040
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Krakow, 30 727
    Poland

    Site Not Available

  • KO-MED Centra Kliniczne LUBLIN

    Lublin, 20-362
    Poland

    Site Not Available

  • Velocity Lublin

    Lublin, 20 362
    Poland

    Site Not Available

  • KO-MED Centra Kliniczne Staszow

    Staszow, 28-200
    Poland

    Site Not Available

  • Velocity Staszow

    Staszow, 28 200
    Poland

    Site Not Available

  • MICS Centrum Medyczne Torun

    Torun, 87-100
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warszawa, 00 874
    Poland

    Site Not Available

  • Synexus Polska Sp z o o Oddzial w Warszawie

    Warszawa, 02 672
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warszawa, 02-672
    Poland

    Active - Recruiting

  • Synexus Polska Sp z o o Oddzial we Wroclawiu

    Wroclaw, 50 381
    Poland

    Site Not Available

  • Synexus Polska Sp z o o Oddzial we Wroclawiu

    Wrocław, 50 381
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wrocław, 50-381
    Poland

    Active - Recruiting

  • Medical Affiliated Research Center Inc. (MARC)

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Alliance for Multispeciality Research

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Optimal Research

    Melbourne, Florida 32934
    United States

    Site Not Available

  • Pharmax Research Clinic Inc

    Miami, Florida 33126
    United States

    Site Not Available

  • Suncoast Research Associates, LLC

    Miami, Florida 33173
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Velocity Clinical Research

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Synexus Clinical Research US Inc

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Optimal Research

    Peoria, Illinois 61614
    United States

    Site Not Available

  • Synexus Radiant Research, Inc

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Heartland Research Associates, LLC

    Newton, Kansas 67114
    United States

    Site Not Available

  • Heartland Research Associates, an AMR Company

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Alliance for Multispeciality Research

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Synexus Clinical Research US Inc

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Accellacare

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • CTI Clinical Trial and Consulting Services

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Velocity Clinical Research

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Velocity Clinical Research

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Alliance for Multispeciality Research

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Benchmark Clinical Research - Austin

    Austin, Texas 78705
    United States

    Site Not Available

  • Optimal Research

    Austin, Texas 78744
    United States

    Site Not Available

  • Tekton Research Inc.

    Beaumont, Texas 77706
    United States

    Site Not Available

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