NCT00956111已完成4 期
A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion and Whole-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,614
- 试验地点
- 1
- 主要终点
- Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children .
研究概览
简要总结
A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female aged 3 and older
- •Be able to show legal identity card for the sake of recruitment
- •Volunteers or their guardians are able to understand and sign the informed consent
排除标准
- •Cases, cured cases and close contact of influenza A (H1N1) virus
- •Women of pregnancy, lactation or about to be pregnant in 60 days
- •Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
- •Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- •Autoimmune disease or immunodeficiency
- •Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
- •Diabetes mellitus (type I or II), with the exception of gestational diabetes
- •History of thyroidectomy or thyroid disease that required medication within the past 12 months
- •Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
- •Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- •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
- •Seizure disorder other than:
- •Febrile seizures under the age of two years old
- •Seizures secondary to alcohol withdrawal more than 3 years ago, or
- •A singular seizure not requiring treatment within the last 3 years
- •Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
- •Guillain-Barre Syndrome
- •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)
- •History of any blood products or seasonal influenza vaccine 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
- •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
Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children .
时间窗: July 2009- Sept. 2009
次要结局
- Provide a basis to determine the best type and dose of vaccine and immunization procedures(July 2009- Sept. 2009)
研究者
研究点 (1)
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