← Back to Search

Cancer Vaccine

ExPEC9V + High-Dose Flu Vaccine for E. coli and Influenza Prevention (Engage Trial)

Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 days post-vaccination 1 on day 1 (day 30) and post-vaccination 2 on day 30 (day 59)
Awards & highlights

Engage Trial Summary

This trial studies the safety & effectiveness of combo vaccines for seasonal flu & E. coli infection.

Who is the study for?
This trial is for adults aged 65 or older who are medically stable, understand the study's risks and benefits, agree not to donate blood during the study period, and women must be postmenopausal. Participants should not expect hospitalization soon and must follow lifestyle restrictions.Check my eligibility
What is being tested?
The study tests if a high-dose flu vaccine (HD QIV) affects antibody response when given with a new E. coli vaccine (ExPEC9V), compared to each vaccine given alone in seniors.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, general symptoms such as fever or fatigue, and possibly allergic responses.

Engage Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 days post-vaccination 1 on day 1 (day 30) and post-vaccination 2 on day 30 (day 59)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 29 days post-vaccination 1 on day 1 (day 30) and post-vaccination 2 on day 30 (day 59) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay 29 days After Administration of ExPEC9V on Day 1
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay 29 days After Administration of ExPEC9V on Day 30
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay
Secondary outcome measures
Antibody Titers to Vaccine O-serotype Antigens and Exotoxin a Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex ECL-based Immunoassay 29 days after administration of ExPEC9V on Day 1 (Day 30) in participants with or without History of Urinary Tract Infection (UTI) at Enrollment
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex ECL-based Immunoassay 29 days after administration of ExPEC9V on Day 30 (Day 59) in participants with or without History of Urinary Tract Infection (UTI) at Enrollment
+11 more

Engage Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2: Control GroupExperimental Treatment3 Interventions
Participants will receive IM injection of matching placebo along with HD quadrivalent influenza vaccine, concomitantly, on Day 1 and ExPEC9V on Day 30.
Group II: Group 1: Coadministration (CoAd) GroupExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,351 Total Patients Enrolled
Janssen Research & Development LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
1 Previous Clinical Trials
18 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are overseeing this clinical research?

"The investigation is accepting participants from Pharmax Research Clinic Inc in Miami, Ohio, MICS Centrum Medyczne Torun in Torun, California and Suncoast Research Associates, LLC in Cincinnati, Missouri as well as an additional 41 sites."

Answered by AI

Is the opportunity to participate in this experiment still available?

"That is correct. As per clinicaltrials.gov, this medical research project, which was inaugurated on October 24th 2023, is actively recruiting participants. Approximately 932 individuals need to be enlisted from 41 different trial sites."

Answered by AI

What goals are investigators hoping to accomplish with this research?

"The primary outcome of this 29-day trial is to assess Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Influenza Vaccine Strains via HI Assay. Additionally, it will measure secondary outcomes such as Antibody Titers to Vaccine O-serotype Antigens and Exotoxin a Derived from Pseudomonas Aeruginosa (EPA), both assessed with Multiplex ECL-based Immunoassay, as well as Opsonophagocytic Antiobdy Titers to vaccine O-serotype antigens through MOPA on Day"

Answered by AI

What is the highest participant count for this clinical investigation?

"This trial necessitates the enrollment of 932 suitable participants, which can be done from two separate clinical sites: Pharmax Research Clinic Inc in Miami, Ohio and MICS Centrum Medyczne Torun in Torun, California."

Answered by AI

Has the FDA sanctioned the CoAd Group of this trial?

"Group 1: Coadministration (CoAd) Group has been assigned a safety rating of 3 due to the existing evidence from Phase 3 trials, which provide support for both its efficacy and security."

Answered by AI

Who else is applying?

What site did they apply to?
Optimal Research
Aggarwal and associates Ltd
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am very interested n contributing to vital medical research and I usually receive some compensation for my time and travel.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is there compensation for time and travel?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06134804.
All > Paid Studies Atlanta > Knoxville
~639 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top