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

Janssen Vaccines & Prevention B.V.0 个研究点目标入组 1,004 人开始时间: 2020年10月8日最近更新: 2020年10月13日

试验速览

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•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 330
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 270

•- 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

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