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

Completed · Phase 3 · Has a placebo group

Conditions studied: Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

In brief

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.

Key facts

Study ID

NCT06134804

Run by

Janssen Research & Development, LLC

People needed

959

Starts

2023-10-24

Expected to finish

2024-07-26

Last updated by the study team

2026-04-03

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Synexus Polska Sp z o o Oddzial w Warszawie — Warsaw, Poland
• Synexus Polska Sp z o o Oddzial we Wroclawiu — Wroclaw, Poland
• MICS Centrum Medyczne Warszawa — Warsaw, Poland
• Medical Affiliated Research Center Inc. (MARC) — Huntsville, Alabama, United States
• Alliance for Multispeciality Research — Mobile, Alabama, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Optimal Research — Melbourne, Florida, United States
• Pharmax Research Clinic Inc — Miami, Florida, United States
• Suncoast Research Associates, LLC — Miami, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Velocity Clinical Research — Savannah, Georgia, United States
• Synexus Clinical Research US Inc — Chicago, Illinois, United States
• Optimal Research — Peoria, Illinois, United States
• Synexus Radiant Research, Inc — Evansville, Indiana, United States
• Heartland Research Associates, LLC — Newton, Kansas, United States
• Heartland Research Associates, an AMR Company — Wichita, Kansas, United States
• Alliance for Multispeciality Research — Lexington, Kentucky, United States
• Synexus Clinical Research US Inc — Creve Coeur, Missouri, United States
• Accellacare — Wilmington, North Carolina, United States
• CTI Clinical Trial and Consulting Services — Cincinnati, Ohio, United States
• Velocity Clinical Research — Cleveland, Ohio, United States
• Velocity Clinical Research — East Greenwich, Rhode Island, United States
• Alliance for Multispeciality Research — Knoxville, Tennessee, United States
• Benchmark Clinical Research - Austin — Austin, Texas, United States

Full record on ClinicalTrials.gov

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