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A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Sponsor: Janssen Research & Development, LLC
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
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.
ExPEC4V
Participants will receive a single IM injection of ExPEC4V on Day 1.
Prevnar 13
Participants will receive a single IM injection of Prevnar 13 on Day 1.
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