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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504168-40-00

Enrollment

400

Registered

2023-09-18

Start date

2023-11-06

Completion date

2024-07-26

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease

Brief summary

Antibody hemagglutination inhibition (HI) titers as measured by HI assay against each of the 4 influenza vaccine strains, 29 days after the administration of a HD quadrivalent seasonal influenza vaccine. Antibody titers to vaccine O-serotype antigens, as determined by multiplex ECL-based immunoassay 29 days after administration of ExPEC9V.

Interventions

DRUGIsotone Natriumchloridlösung 0

DRUG9 % Braun Injektionslösung

DRUGEFLUELDA

DRUGsuspension injectable en seringue préremplie Vaccin grippal quadrivalent (virion fragmenté

DRUGinactivé)

DRUG60 microgrammes HA /souche

DRUGJNJ-78901563

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Antibody hemagglutination inhibition (HI) titers as measured by HI assay against each of the 4 influenza vaccine strains, 29 days after the administration of a HD quadrivalent seasonal influenza vaccine. Antibody titers to vaccine O-serotype antigens, as determined by multiplex ECL-based immunoassay 29 days after administration of ExPEC9V.	—

Countries

Belgium, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026