NCT00556062已完成4 期
The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 566
- 主要终点
- Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B
研究概览
简要总结
To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-60 years old
- •Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
- •Not participate in any other clinical trials during the study
- •Not receive any immunosuppressive agents during and one month prior to the study
- •Be able to understand and sign the informed consent.
排除标准
- •Woman： Who breast-feeding or planning to become pregnant during the study
- •Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
- •Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- •Autoimmune disease or immunodeficiency
- •Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
- •Guillain-Barre Syndrome
- •Women subjects with positive urinary pregnancy test
- •Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- •Axillary temperature >37.0 centigrade at the time of dosing
- •Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
- •Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
结局指标
主要结局
Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B
时间窗: 0, 21 days
次要结局
- local and systematic adverse reactions after vaccination(within 3 days after vaccination)
研究者
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