A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860
Completed · Phase 2 · Has a placebo group
Conditions studied: Healthy
In brief
The purpose of this study is to evaluate the safety, tolerability of different doses of JNJ-63871860 (ExPEC4V) in participants greater than or equal to (\>=)18 years of age and to evaluate the dose-dependent immunogenicity of ExPEC as measured by enzyme-linked immunosorbent assay (ELISA).
Key facts
- Study ID
- NCT02546960
- Run by
- Janssen Research & Development, LLC
- People needed
- 848
- Starts
- 2015-11-12
- Expected to finish
- 2019-06-21
- Last updated by the study team
- 2020-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Participant must be in stable health. Participants may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and is expected to remain stable for the duration of the study
- Participant must meet the protocol defined laboratory criteria within 12 days before Day 1
- Participant must be able to attend all scheduled visits and to comply with all study procedures
- Participant must have a body mass index (BMI) of less than or equal to (<=) 35 kilogram per square meter (kg/m\^2)
- A woman of childbearing potential must have a negative urine pregnancy test on Day 1 before vaccination
You may not qualify if…
- Participant is a woman who is pregnant, breast-feeding, or has a positive urine pregnancy test on Day 1 before vaccination, or is planning to become pregnant 3 months after study vaccine administration or within 3 months after study vaccine administration, or subject is a man who plans to father a child while enrolled in this study or within 3 months after study vaccine administration
- Participant has an acute illness, acute infection, or fever (body temperature greater than or equal to [>=] 38 degree Celsius)
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (example compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has a history of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy
- Participant has known or suspected congenital or acquired immunodeficiency (including leukemia, HIV seropositivity), has received immunosuppressive therapy (such as anti-cancer chemotherapy, radiation therapy or cytotoxic drugs), within the preceding 6 months; or long-term systemic corticosteroid therapy [prednisone or equivalent for more than 2 consecutive weeks within the past 3 months]), or has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
Where it is running
- Study site — Mesa, Arizona, United States
- Study site — Hollywood, Florida, United States
- Study site — Leesburg, Florida, United States
- Study site — Miami, Florida, United States
- Study site — Boise, Idaho, United States
- Study site — Wichita, Kansas, United States
- Study site — Bardstown, Kentucky, United States
- Study site — Baltimore, Maryland, United States
- Study site — Saint Paul, Minnesota, United States
- Study site — Kansas City, Missouri, United States
- Study site — Las Vegas, Nevada, United States
- Study site — Cary, North Carolina, United States
- Study site — Raleigh, North Carolina, United States
- Study site — Cincinnati, Ohio, United States
- Study site — Knoxville, Tennessee, United States
- Study site — Austin, Texas, United States
- Study site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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