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One shot, two protections? new study combines e. coli and flu vaccines for seniors

NCT ID NCT06134804

Prevention Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a new vaccine against certain E. coli bacteria (ExPEC9V) can be given at the same time as a high-dose flu shot in adults aged 65 and older. The goal was to see if the immune response to both vaccines remains strong when given together. About 959 participants took part, and the study looked at antibody levels 29 days after vaccination.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ExPEC9V (a vaccine against certain types of E. coli bacteria) and high-dose quadrivalent influenza vaccine
What this could lead to
If successful, this could show that older adults can get protection against both severe E. coli infections and flu with a single visit, simplifying vaccination schedules.
What could go wrong
This is a completed phase 3 trial focused on immune response, not on directly proving the vaccine prevents disease. The results may not guarantee real-world effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

959 people

The number who actually took part.

Started

Oct 2023

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

escherichia coli infection influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Invasive extraintestinal pathogenic escherichia coli disease (IED) prevention

Contacts and locations

Locations

  • Accellacare

    Wilmington, North Carolina, 28401, United States

  • Aggarwal and associates Ltd

    Brampton, Ontario, L6T 0G1, Canada

  • Alliance for Multispeciality Research

    Mobile, Alabama, 36608, United States

  • Alliance for Multispeciality Research

    Lexington, Kentucky, 40509, United States

  • Alliance for Multispeciality Research

    Knoxville, Tennessee, 37909, United States

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331, United States

  • Az Sint-Maarten

    Mechelen, 2800, Belgium

  • Benchmark Clinical Research - Austin

    Austin, Texas, 78705, United States

  • CTI Clinical Trial and Consulting Services

    Cincinnati, Ohio, 45212, United States

  • Center for Vaccinology (CEVAC)

    Ghent, 9000, Belgium

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

    Lévis, Quebec, G6W 0M5, Canada

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114, United States

  • Heartland Research Associates, an AMR Company

    Wichita, Kansas, 67207, United States

  • MICS Centrum Medyczne Torun

    Torun, 87-100, Poland

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00 874, Poland

  • Medical Affiliated Research Center Inc. (MARC)

    Huntsville, Alabama, 35801, United States

  • Milestone Research

    London, Ontario, N5W 6A2, Canada

  • Optimal Research

    Melbourne, Florida, 32934, United States

  • Optimal Research

    Peoria, Illinois, 61614, United States

  • Optimal Research

    Austin, Texas, 78744, United States

  • PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.

    Gdansk, 80405, Poland

  • Pharmax Research Clinic Inc

    Miami, Florida, 33126, United States

  • Pratia MCM Krakow

    Krakow, 30 727, Poland

  • Suncoast Research Associates, LLC

    Miami, Florida, 33173, United States

  • Synexus Clinical Research US Inc

    Chicago, Illinois, 60602, United States

  • Synexus Clinical Research US Inc

    Creve Coeur, Missouri, 63141, United States

  • Synexus Polska Sp z o o Oddzial w Katowicach

    Katowice, 40 040, Poland

  • Synexus Polska Sp z o o Oddzial w Warszawie

    Warsaw, 02 672, Poland

  • Synexus Polska Sp z o o Oddzial we Wroclawiu

    Wroclaw, 50 381, Poland

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

    Gdansk, 80 382, Poland

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

    Gdynia, 81 537, Poland

  • Synexus Radiant Research, Inc

    Evansville, Indiana, 47714, United States

  • Tekton Research Inc.

    Beaumont, Texas, 77706, United States

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

    Edegem, 2650, Belgium

  • Velocity Clinical Research

    Savannah, Georgia, 31406, United States

  • Velocity Clinical Research

    Cleveland, Ohio, 44122, United States

  • Velocity Clinical Research

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Lublin

    Lublin, 20 362, Poland

  • Velocity Staszow

    Staszów, 28 200, Poland

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