NCT06134804

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 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 959 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Interventions

Type	Name	Description
BIOLOGICAL	ExPEC9V	ExPEC9V will be administered as an IM injection.
BIOLOGICAL	Placebo	Placebo will be administered as an IM injection.
BIOLOGICAL	HD quadrivalent influenza vaccine	HD quadrivalent influenza vaccine will be administered as IM injection.

Timeline

• Start date: 2023-10-24
• Primary completion: 2024-02-19
• Completion: 2024-07-26
• First posted: 2023-11-18
• Last updated: 2026-04-03
• Results posted: 2026-04-03

Locations

41 sites across 4 countries: United States, Belgium, Canada, Poland

Regulatory

• FDA-regulated drug study