drugset / 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

NCT06134804 ↗

Phase 3 Completed 959 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2023-10-24
Primary completion
2024-02-19
Completion
2024-07-26

Drugs

EvaluationDrugModalityDoseRoute
Subject ExPEC9V Vaccine — Intramuscular
Subject HD quadrivalent influenza vaccine Vaccine — Intramuscular

Indications

No indication recorded.