Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) PreventionPhase 3EngageNCT06134804
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
A Phase 3 study testing ExPEC9V and HD quadrivalent influenza vaccine in people with Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention, run by Janssen Research & Development, LLC at 41 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
- What is being tested?
- ExPEC9V and HD quadrivalent influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 959 participants
- Where
- 41 sitesin 4 countries
- Study dates
- 24 Oct 2023to 26 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
41 sites in 4 countries.
41 sites in 4 countries
United States24 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Benchmark Clinical Research - Austin
Austin, Texas, 78705
Optimal Research
Austin, Texas, 78744
Tekton Research Inc.
Beaumont, Texas, 77706
Synexus Clinical Research US Inc
Chicago, Illinois, 60602
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212
Velocity Clinical Research
Cleveland, Ohio, 44122
Synexus Clinical Research US Inc
Creve Coeur, Missouri, 63141
Velocity Clinical Research
East Greenwich, Rhode Island, 02818
Synexus Radiant Research, Inc
Evansville, Indiana, 47714
Medical Affiliated Research Center Inc. (MARC)
Huntsville, Alabama, 35801
Alliance for Multispeciality Research
Knoxville, Tennessee, 37909
Alliance for Multispeciality Research
Lexington, Kentucky, 40509
Optimal Research
Melbourne, Florida, 32934
Pharmax Research Clinic Inc
Miami, Florida, 33126
Suncoast Research Associates, LLC
Miami, Florida, 33173
Alliance for Multispeciality Research
Mobile, Alabama, 36608
Heartland Research Associates, LLC
Newton, Kansas, 67114
Optimal Research
Peoria, Illinois, 61614
Artemis Institute for Clinical Research
San Diego, California, 92103
Velocity Clinical Research
Savannah, Georgia, 31406
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Heartland Research Associates, an AMR Company
Wichita, Kansas, 67207
Accellacare
Wilmington, North Carolina, 28401
Poland11 sites
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, 80 382
PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
Gdansk, 80405
Synexus Polska Sp. z o.o. Oddzial w Gdynia
Gdynia, 81 537
Synexus Polska Sp z o o Oddzial w Katowicach
Katowice, 40 040
Pratia MCM Krakow
Krakow, 30 727
Velocity Lublin
Lublin, 20 362
Velocity Staszow
Staszów, 28 200
MICS Centrum Medyczne Torun
Torun, 87-100
MICS Centrum Medyczne Warszawa
Warsaw, 00 874
Synexus Polska Sp z o o Oddzial w Warszawie
Warsaw, 02 672
Synexus Polska Sp z o o Oddzial we Wroclawiu
Wroclaw, 50 381
Belgium3 sites
Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV)
Edegem, 2650
Center for Vaccinology (CEVAC)
Ghent, 9000
Az Sint-Maarten
Mechelen, 2800
Canada3 sites
Aggarwal and associates Ltd
Brampton, Ontario, L6T 0G1
Centricity Research- Manna Research (MR) - Quebec Location
Lévis, Quebec, G6W 0M5
Milestone Research
London, Ontario, N5W 6A2
About this study
Official title: 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.
- Being tested
- ExPEC9V, Placebo, HD quadrivalent influenza vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExPEC9VBiological
Also called VAC52416; JNJ-78901563
ExPEC9V will be administered as an IM injection.
PlaceboBiological
Placebo will be administered as an IM injection.
HD quadrivalent influenza vaccineBiological
HD quadrivalent influenza vaccine will be administered as IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Coadministration (CoAd) Group | Experimental | 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. Receives: Biological: ExPEC9V; Biological: Placebo; Biological: HD quadrivalent influenza vaccine |
| Group 2: Control Group | Experimental | Participants will receive IM injection of matching placebo along with HD quadrivalent influenza vaccine, concomitantly, on Day 1 and ExPEC9V on Day 30. Receives: Biological: ExPEC9V; Biological: Placebo; Biological: HD quadrivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 29 days after the administration of ExPEC9V on Day 30 (Day 59)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Oct 2023
- Primary completion19 Feb 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) PreventionStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134804
- Sponsor's protocol ID
- CR109338
- Other IDs
- 2023-504168-40-00, VAC52416BAC3002, 2023
- Acronym
- Engage
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2023
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06134804
- Acronym / sponsor ID
- Engage / CR109338
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Posted 3 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Coadministration (CoAd) Group | Experimental | Biological: ExPEC9V, Biological: Placebo, Biological: HD quadrivalent influenza vaccineParticipants 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. |
| Group 2: Control Group | Experimental | Biological: ExPEC9V, Biological: Placebo, Biological: HD quadrivalent influenza vaccineParticipants will receive IM injection of matching placebo along with HD quadrivalent influenza vaccine, concomitantly, on Day 1 and ExPEC9V on Day 30. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExPEC9VAlso: VAC52416; JNJ-78901563ExPEC9V will be administered as an IM injection. | Biological | Group 1: Coadministration (CoAd) Group, Group 2: Control Group |
| PlaceboPlacebo will be administered as an IM injection. | Biological | Group 1: Coadministration (CoAd) Group, Group 2: Control Group |
| HD quadrivalent influenza vaccineHD quadrivalent influenza vaccine will be administered as IM injection. | Biological | Group 1: Coadministration (CoAd) Group, Group 2: Control Group |
Primary outcome
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
Time frame: 29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)
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.
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
Time frame: 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)
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.
14 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 29 days after the administration of ExPEC9V on Day 30 (Day 59)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development LLC Clinical Trial study director
Janssen Research & Development, LLC
41 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ExPEC9V and HD quadrivalent influenza vaccine in people with Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention, run by Janssen Research & Development, LLC at 41 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Poland, Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.