clinical trial · 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
Janssen Research & Development, LLC·phase3·completed·n = 959
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) PreventionExPEC9VPlaceboHD quadrivalent influenza vaccine
brief 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.
started
Oct 24, 2023
primary completion
Feb 19, 2024
completion
Jul 26, 2024
last updated
Apr 3, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol