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 (Engage)

A Phase 3 Randomized Double-blind Controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of ExPEC9V and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older

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.

Study Overview

• Status: Completed
• Conditions: Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
• Intervention / Treatment: Biological: ExPEC9V; Biological: Placebo; Biological: HD quadrivalent influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 959
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV)
  • Ghent, Belgium, 9000
    • Center for Vaccinology (CEVAC)
  • Mechelen, Belgium, 2800
    • AZ Sint-Maarten
• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Ltd
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research
  • Quebec
    • Lévis, Quebec, Canada, G6W 0M5
      • Centricity Research- Manna Research (MR) - Quebec Location
• Poland
  • Gdansk, Poland, 80405
    • PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
  • Gdansk, Poland, 80 382
    • Synexus Polska Sp. z o.o. Oddzial w Gdansku
  • Gdynia, Poland, 81 537
    • Synexus Polska Sp. z o.o. Oddzial w Gdynia
  • Katowice, Poland, 40 040
    • Synexus Polska Sp z o o Oddzial w Katowicach
  • Krakow, Poland, 30 727
    • PRATIA MCM Kraków
  • Lublin, Poland, 20 362
    • Velocity Lublin
  • Staszów, Poland, 28 200
    • Velocity Staszow
  • Torun, Poland, 87-100
    • MICS Centrum Medyczne Torun
  • Warsaw, Poland, 02 672
    • Synexus Polska Sp z o o Oddzial w Warszawie
  • Warsaw, Poland, 00 874
    • MICS Centrum Medyczne Warszawa
  • Wroclaw, Poland, 50 381
    • Synexus Polska Sp z o o Oddzial we Wroclawiu
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center Inc. (MARC)
    • Mobile, Alabama, United States, 36608
      • Alliance for Multispeciality Research
  • California
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Melbourne, Florida, United States, 32934
      • Optimal Research
    • Miami, Florida, United States, 33173
      • Suncoast Research Associates, LLC
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic Inc
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Savannah, Georgia, United States, 31406
      • Velocity Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Synexus Clinical Research US Inc
    • Peoria, Illinois, United States, 61614
      • Optimal Research
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Synexus Radiant Research, Inc
  • Kansas
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, an AMR Company
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Alliance for Multispeciality Research
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Synexus Clinical Research US Inc
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Trial and Consulting Services
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Alliance for Multispeciality Research
  • Texas
    • Austin, Texas, United States, 78744
      • Optimal Research
    • Austin, Texas, United States, 78705
      • Benchmark Clinical Research - Austin
    • Beaumont, Texas, United States, 77706
      • Tekton Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 informed consent form (ICF) signature and vaccination
• Participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
• Must sign an ICF indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
• 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 after receiving the last dose of study vaccine

Exclusion Criteria:

• History of an underlying clinically significant acute or uncontrolled chronic medical condition or significant cognitive impairment or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Known or suspected allergy or history of severe allergic reaction, anaphylaxis, or other serious adverse reactions to vaccines or vaccine excipients
• History of severe allergic reactions (for example anaphylaxis) to any component of the 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 before administration of the first study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
• History of acute polyneuropathy (for example, Guillain-Barré syndrome) or chronic inflammatory demyelinating polyneuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Coadministration (CoAd) Group; Participants will receive intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) along with high-dose (HD) quadrivalent influenza vaccine, concomitantly, on Day 1 and placebo on Day 30.	Biological: ExPEC9V; ExPEC9V will be administered as an IM injection.; Other Names: VAC52416; JNJ-78901563; Biological: Placebo; Placebo will be administered as an IM injection.; Biological: HD quadrivalent influenza vaccine; HD quadrivalent influenza vaccine will be administered as IM injection.
Experimental: Group 2: Control Group; Participants will receive IM injection of matching placebo along with HD quadrivalent influenza vaccine, concomitantly, on Day 1 and ExPEC9V on Day 30.	Biological: ExPEC9V; ExPEC9V will be administered as an IM injection.; Other Names: VAC52416; JNJ-78901563; Biological: Placebo; Placebo will be administered as an IM injection.; Biological: HD quadrivalent influenza vaccine; HD quadrivalent influenza vaccine will be administered as IM injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemagglutination Inhibition (HI) Antibody Titers Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of High-Dose (HD) Quadrivalent Seasonal Influenza Vaccine	HI antibody titers against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza vaccine strains 29 days after the administration of HD quadrivalent seasonal influenza vaccine as measured by HI assay were reported.	29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V	Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by ECL based Immunoassay 29 days after administration of ExPEC9V on Day 1 in CoAd group and on Day 30 in Control group were reported.	CoAd Group: 29 days after the administration of ExPEC9V on Day 1 (Day 30); Control Group: 29 days after the administration of ExPEC9V on Day 30 (Day 59)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Seroconversion Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine	Seroconversion was defined for each of the 4 influenza vaccine strains as 1) HI titer greater than or equal to (>=) 1:40 in participants with a pre-vaccination HI titer of less than (<) 1:10, or 2) a >=4-fold HI titer increase in participants with a pre-vaccination HI titer of >=1:10.	29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)
Percentage of Participants With Seroprotection Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine	Seroprotection was defined for each of the 4 influenza vaccine strains as HI titer >=1:40 at 29 days after the administration of a HD quadrivalent seasonal influenza vaccine.	29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Each Vaccination	An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) events for which participants were to be specifically questioned and which were noted by participants in their participant diary for 14 days post vaccination (day of vaccination and the subsequent 14 days). Solicited local AEs were injection site pain or tenderness, erythema and swelling at the study vaccine injection site.	Up to 14 days post-vaccination 1 on Day 1 (Day 1 up to Day 15) and up to 14 days post-vaccination 2 on Day 30 (Day 30 up to Day 44)
Percentage of Participants With Solicited Systemic AEs for 14 Days After Each Vaccination	An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine and were pre-defined systemic events for which participants were to be specifically questioned and which were noted by participants in their participant diary for 14 days post vaccination (day of vaccination and the subsequent 14 days). Solicited systemic AEs included fever (body temperature >=100.4 degree Fahrenheit), fatigue, headache, nausea, myalgia, and fever.	Up to 14 days post-vaccination 1 on Day 1 (Day 1 up to Day 15) and up to 14 days post-vaccination 2 on Day 30 (Day 30 up to Day 44)
Percentage of Participants With Unsolicited AEs for 29 Days After Each Vaccination	Percentage of participants with unsolicited AEs for 29 days after each vaccination was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.	Up to 29 days post-vaccination 1 on Day 1 (Day 1 up to Day 30) and up to 29 days post-vaccination 2 on Day 30 (Day 30 up to Day 59)
Percentage of Participants With Medically-attended Adverse Events (MAAEs) From Vaccination 1 Until 6 Months After Vaccination 2	MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination.	From vaccination 1 on Day 1 up to 6 months after vaccination 2 on Day 30 (up to Day 210)
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 Until 6 Months After Vaccination 2	Percentage of participants with SAEs from vaccination 1 to until 6 months after vaccination 2 was reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.	From vaccination 1 on Day 1 up to 6 months after vaccination 2 on Day 30 (up to Day 210)
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay	Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) and EPA as determined by multiplex ECL-based immunoassay were reported.	CoAd Group: Day 1 (Day of ExPEC9V vaccination), Day 30 (29 days after ExPEC9V vaccination), Day 59 (58 days after ExPEC9V vaccination); Control Group: Day 30 (Day of ExPEC9V vaccination), Day 59 (29 days after ExPEC9V vaccination)
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)	Opsonophagocytic antibody titers to vaccine O-serotype antigens O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 as determined by MOPA were reported.	29 days after the administration of ExPEC9V vaccine on Day 1 (Day 30)
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)	Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by MOPA were reported.	29 days after the administration of ExPEC9V vaccine on Day 30 (Day 59)
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay	Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by multiplex ECL-based immunoassay were reported.	29 days after the administration of ExPEC9V on Day 1 (Day 30)
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay	Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by multiplex ECL-based immunoassay were reported.	29 days after the administration of ExPEC9V on Day 30 (Day 59)
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)	Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by MOPA were reported.	29 days after the administration of ExPEC9V on Day 1 (Day 30)
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)	Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by MOPA were reported.	29 days after the administration of ExPEC9V on Day 30 (Day 59)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Actual): February 19, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Enterobacteriaceae Infections; Escherichia coli Infections
• Other Study ID Numbers: CR109338; 2023-504168-40-00 (Registry Identifier: EUCT number); VAC52416BAC3002 (Other Identifier: Janssen Research & Development LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No