A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Extraintestinal Pathogenic Escherichia Coli Prevention
In brief
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.
Key facts
- Study ID
- NCT03819049
- Run by
- Janssen Research & Development, LLC
- People needed
- 836
- Starts
- 2019-06-06
- Expected to finish
- 2024-12-18
- Last updated by the study team
- 2026-06-05
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Must have a body mass index (BMI) of greater than (>) 18.5 or less than 40 kilogram per meter square (kg/m\^2)
- Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods
- Must be healthy or medically stable
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
- Agrees not to donate blood until 12 weeks after receiving the study vaccine
You may not qualify if…
- Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than equal to >=38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic urinary tract infection (UTI); enrollment at a later date is permitted (provided the screening window of 28 days is respected)
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
- Applicable for Cohort 1 only: known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the active control vaccines)
- Contraindication to intramuscular (IM) injections and blood draws example, bleeding disorders
- Abnormal function of the immune system
- Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12 months
Where it is running
- 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
Full record on ClinicalTrials.gov
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