NCT00460486已完成3 期
Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 330
- 试验地点
- 8
- 主要终点
- Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.
研究概览
简要总结
The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects will be eligible for participation in this study if they:
- •Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age);
- •Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age);
- •Are aged >= 16 years (from the 16th birthday) at screening;
- •Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial);
- •Have a negative pregnancy test result at the first medical examination (if female and capable of bearing children);
- •Agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children);
- •Agree to keep a Subject Diary.
排除标准
- •Subjects will be excluded from participation in this study if they:
- •Have a history of any previous tick-borne encephalitis (TBE) vaccination;
- •Have a history of TBE infection;
- •Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis);
- •Have a history of allergic reactions, in particular to one of the components of the vaccine;
- •Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
- •Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages);
- •Have donated blood or plasma within 30 days of study entry;
- •Have received a blood transfusion or immunoglobulins within 30 days of study entry;
- •Are known to be HIV positive (an HIV test is not required specifically for the purpose of this study);
- •Are simultaneously participating in another clinical trial including administration of an investigational product;
- •Have participated in any other clinical study within six weeks prior to study entry;
- •Are pregnant or breastfeeding (if female);
- •Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
- •Have received any other vaccination within two weeks prior to study entry.
结局指标
主要结局
Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.
次要结局
未报告次要终点
研究者
研究点 (8)
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