NL-OMON52538招募中不适用
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 - VAC52416BAC1001
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Must have a body mass index (BMI) of >18.5 to<40kg/m2;
- •- Before randomization, a woman must be:
- •a). postmenopausal - A postmenopausal state is defined as no menses for 12
- •months without an alternative medical cause; or
- •b). not intending to conceive by any methods;
- •- Must be healthy or medically stable
- •- Must sign an 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
- •- Agrees not to donate blood until 12 weeks after receiving the study vaccine
排除标准
- •- Acute illness (this does not include minor illnesses such as diarrhea or mild
- •upper respiratory tract infection) or temperature >=38.0ºC (100.4°F) within 24
- •hours prior to the administration of study vaccine, or, applicable for Cohort 2
- •only, an ongoing or suspected symptomatic UTI; enrollment at a later date is
- •permitted (provided the screening window of 28days 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 (refer to Investigator's Brochure);
- •- Contraindication to IM injections and blood draws eg, bleeding disorders;
- •- Abnormal function of the immune system
- •- Has had major psychiatric illness and/or drug substance or alcohol abuse in
- •the past 12months
研究者
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