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COMPLETED
NCT03819049
PHASE1/PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.

Official title: A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

836

Start Date

2019-06-06

Completion Date

2024-12-18

Last Updated

2026-06-05

Healthy Volunteers

Yes

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.

Locations (29)

Optimal Research 2

Huntsville, Alabama, United States

Optimal Research

Melbourne, Florida, United States

Qps-Mra, Llc

Miami, Florida, United States

Optimal Research 1

Peoria, Illinois, United States

Synexus Clinical Research US Inc 4

Evansville, Indiana, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Synexus Clinical Research US Inc 2

Richfield, Minnesota, United States

Synexus Clinical Research US Inc 3

Manhattan, New York, United States

Rochester Clinical Research, Inc

Rochester, New York, United States

Synexus Clinical Research US Inc 1

Akron, Ohio, United States

Synexus Clinical Research US Inc

Columbus, Ohio, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Anima

Alken, Belgium

ATC Pharma

Liège, Belgium

Clinical Pharmacology Unit

Merksem, Belgium

CHU Nantes

Nantes, France

Hopital Cochin

Paris, France

APHP - Hopital Bichat - Claude Bernard

Paris, France

CHU Lyon Sud

Pierre-Bénite, France

Chu Rennes Hopital Pontchaillou

Rennes, France

CHRU Tours Hopital Bretonneau

Tours, France

EB Flevo Research

Almere Stad, Netherlands

PRA Health Sciences

Groningen, Netherlands

Hosp. Del Mar

Barcelona, Spain

Hosp Reina Sofia

Córdoba, Spain

Hosp. Univ. de La Princesa

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Hosp. Virgen Macarena

Seville, Spain