NCT01404182已完成4 期
Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine (Trivalent, Seasonal, Active Ingredient Content: 15 μg HA/Strain/0.5 mL) in Adults and Elderly Persons
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 4
- 主要终点
- Post vaccination HI antibody titer
研究概览
简要总结
The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB trivalent influenza vaccine in adults and elderly people.
详细描述
Immunogenicity Objective:
To assess immunogenicity of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.
Safety and Tolerability Objectives:
To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 60 years, elderly persons aged over 60 years, both sexes, mentally competent
- •Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study
- •Female volunteers aged 18-60 years (i.e. participants of childbearing potential) with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study.
- •Capability of participants to understand and comply with planned study procedures
- •Participants aged above 18 years provide written informed consent prior to initiation of study procedures
- •Absence of existence of any exclusion criteria.
排除标准
- •Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
- •Known hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine
- •History of Guillain-Barré syndrome
- •History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- •Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure
- •Immunosuppressive therapy within the past 36 months
- •Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids
- •Receipt of immunostimulants,
- •Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within the past 3 months
- •Suspected or HIV, HBV or HCV infection
- •Acute disease and/or axillary temperature ≥37oC within the past 3 days
- •Vaccine therapy within the past 4 weeks
- •Influenza vaccination (any kind) within the past 6 months
- •Experimental drug therapy within the past 4 weeks
- •Concomitant participation in another clinical study
- •Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study
- •Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have effect on the objective decision-making of the volunteer
- •Alcohol or drug abuse of the participant.
结局指标
主要结局
Post vaccination HI antibody titer
时间窗: 21-28 days following vaccination
次要结局
- Incidence of adverse reactions(21-28 days following vaccination)
研究者
研究点 (4)
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