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

PHASE3CompletedINTERVENTIONAL
Enrollment

959

Participants

Timeline

Start Date

October 24, 2023

Primary Completion Date

February 19, 2024

Study Completion Date

July 26, 2024

Conditions
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
Interventions
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.

Trial Locations (41)

2650

Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV), Edegem

2800

Az Sint-Maarten, Mechelen

9000

Center for Vaccinology (CEVAC), Ghent

28401

Accellacare, Wilmington

30331

Atlanta Center for Medical Research, Atlanta

31406

Velocity Clinical Research, Savannah

32934

Optimal Research, Melbourne

33126

Pharmax Research Clinic Inc, Miami

33173

Suncoast Research Associates, LLC, Miami

35801

Medical Affiliated Research Center Inc. (MARC), Huntsville

36608

Alliance for Multispeciality Research, Mobile

37909

Alliance for Multispeciality Research, Knoxville

40509

Alliance for Multispeciality Research, Lexington

44122

Velocity Clinical Research, Cleveland

45212

CTI Clinical Trial and Consulting Services, Cincinnati

47714

Synexus Radiant Research, Inc, Evansville

60602

Synexus Clinical Research US Inc, Chicago

61614

Optimal Research, Peoria

63141

Synexus Clinical Research US Inc, Creve Coeur

67114

Heartland Research Associates, LLC, Newton

67207

Heartland Research Associates, an AMR Company, Wichita

77706

Tekton Research Inc., Beaumont

78705

Benchmark Clinical Research - Austin, Austin

78744

Optimal Research, Austin

80405

PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p., Gdansk

92103

Artemis Institute for Clinical Research, San Diego

94598

Diablo Clinical Research, Inc., Walnut Creek

02818

Velocity Clinical Research, East Greenwich

L6T 0G1

Aggarwal and associates Ltd, Brampton

N5W 6A2

Milestone Research, London

G6W 0M5

Centricity Research- Manna Research (MR) - Quebec Location, Lévis

80 382

Synexus Polska Sp. z o.o. Oddzial w Gdansku, Gdansk

81 537

Synexus Polska Sp. z o.o. Oddzial w Gdynia, Gdynia

40 040

Synexus Polska Sp z o o Oddzial w Katowicach, Katowice

30 727

Pratia MCM Krakow, Krakow

20 362

Velocity Lublin, Lublin

28 200

Velocity Staszow, Staszów

87-100

MICS Centrum Medyczne Torun, Torun

00 874

MICS Centrum Medyczne Warszawa, Warsaw

02 672

Synexus Polska Sp z o o Oddzial w Warszawie, Warsaw

50 381

Synexus Polska Sp z o o Oddzial we Wroclawiu, Wroclaw

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter