NCT00660257已完成1 期
Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- HI antibody Neutralization antibody
研究概览
简要总结
A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Had received two-dose priming vaccination in previous phase I trial
- •Be able to show legal identity card for the sake of recruitment
- •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 to vaccines or eggs
- •Autoimmune disease or immunodeficiency
- •Diabetes mellitus (type I or II), with the exception of gestational diabetes
- •Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
- •Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
- •Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
- •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
- •History of any blood products administration within 3 months before the dosing
- •Administration of any other investigational research agents within 30 days before the dosing
- •Administration of any live attenuated vaccine within 30 days before the dosing
- •Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
- •Be receiving anti-TB prophylaxis or therapy currently
- •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
HI antibody Neutralization antibody
时间窗: 15 and 30 days after the booster dose
次要结局
- local adverse reactions systemic adverse reactions temperature(3 days after booster dose)
研究者
研究点 (1)
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