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
Public ClinicalTrials.gov record NCT06134804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06134804
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 959 participants
Conditions and interventions
Interventions
- ExPEC9V Biological
- Placebo Biological
- HD quadrivalent influenza vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 24, 2023 (Actual)
- Primary completion
- Feb 19, 2024 (Actual)
- Completion
- Jul 26, 2024 (Actual)
- Last update posted
- Apr 3, 2026
2023 – 2024
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Affiliated Research Center Inc. (MARC) | Huntsville | Alabama | 35801 | — |
| Alliance for Multispeciality Research | Mobile | Alabama | 36608 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Optimal Research | Melbourne | Florida | 32934 | — |
| Pharmax Research Clinic Inc | Miami | Florida | 33126 | — |
| Suncoast Research Associates, LLC | Miami | Florida | 33173 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Velocity Clinical Research | Savannah | Georgia | 31406 | — |
| Synexus Clinical Research US Inc | Chicago | Illinois | 60602 | — |
| Optimal Research | Peoria | Illinois | 61614 | — |
| Synexus Radiant Research, Inc | Evansville | Indiana | 47714 | — |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | — |
| Heartland Research Associates, an AMR Company | Wichita | Kansas | 67207 | — |
| Alliance for Multispeciality Research | Lexington | Kentucky | 40509 | — |
| Synexus Clinical Research US Inc | Creve Coeur | Missouri | 63141 | — |
| Accellacare | Wilmington | North Carolina | 28401 | — |
| CTI Clinical Trial and Consulting Services | Cincinnati | Ohio | 45212 | — |
| Velocity Clinical Research | Cleveland | Ohio | 44122 | — |
| Velocity Clinical Research | East Greenwich | Rhode Island | 02818 | — |
| Alliance for Multispeciality Research | Knoxville | Tennessee | 37909 | — |
| Benchmark Clinical Research - Austin | Austin | Texas | 78705 | — |
| Optimal Research | Austin | Texas | 78744 | — |
| Tekton Research Inc. | Beaumont | Texas | 77706 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06134804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 3, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06134804 live on ClinicalTrials.gov.