A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

836

Participants

Timeline

Start Date

June 6, 2019

Primary Completion Date

June 8, 2021

Study Completion Date

December 18, 2024

Conditions
Extraintestinal Pathogenic Escherichia Coli Prevention
Interventions
BIOLOGICAL

ExPEC10V

Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.

BIOLOGICAL

ExPEC4V

Participants will receive a single IM injection of ExPEC4V on Day 1.

BIOLOGICAL

Prevnar 13

Participants will receive a single IM injection of Prevnar 13 on Day 1.

BIOLOGICAL

Placebo

Participants will receive single IM injection of matching placebo on Day 1.

Trial Locations (29)

2170

Clinical Pharmacology Unit, Merksem

3570

Anima, Alken

4000

ATC Pharma, Liège

10017

Synexus Clinical Research US Inc, Manhattan

14004

Hosp Reina Sofia, Córdoba

14609

Rochester Clinical Research, Inc, Rochester

28006

Hosp. Univ. de La Princesa, Madrid

28046

Hosp. Univ. La Paz, Madrid

29405

Coastal Carolina Research Center, North Charleston

32934

Optimal Research, Melbourne

33143

Qps-Mra, Llc, Miami

35000

Chu Rennes Hopital Pontchaillou, Rennes

35802

Optimal Research, Huntsville

37000

CHRU Tours Hopital Bretonneau, Tours

39008

Hosp. Univ. Marques de Valdecilla, Santander

41009

Hosp. Virgen Macarena, Seville

43212

Synexus Clinical Research US Inc, Columbus

44093

CHU Nantes, Nantes

44311

Synexus Clinical Research US Inc, Akron

47714

Synexus Clinical Research US Inc, Evansville

55432

Synexus Clinical Research US Inc, Richfield

61614

Optimal Research, Peoria

66219

Johnson County Clin-Trials, Lenexa

69495

CHU Lyon Sud, Pierre-Bénite

75014

Hopital Cochin, Paris

75018

APHP - Hopital Bichat - Claude Bernard, Paris

1311 RL

EB Flevo Research, Almere Stad

NZ 9728

PRA Health Sciences, Groningen

08003

Hosp. Del Mar, Barcelona

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03819049 - A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health | Biotech Hunter | Biotech Hunter