NCT01336166已完成2 期
The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine
Shanghai Institute Of Biological Products1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2009年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Hemagglutination inhibition antibody titer
研究概览
简要总结
The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent
- •Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy
- •Requests of clinical research program can be obeyed
- •No other protective product is inoculated in last week
- •Axillary temperature below 37 degrees Celsius
排除标准
- •Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- •Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
- •History of progressive or severe neurologic disorder
- •Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- •Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
- •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
- •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
- •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
- •Guillain-Barre Syndrome
- •Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- •Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
- •Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
- •Any conditions may influence the evaluation
研究组 & 干预措施
split-virion, non-adjuvanted vaccine of 15 μg
Experimental
split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
干预措施: split-virion, non-adjuvanted H1N1 vaccine of 15 μg (Biological)
split-virion, non-adjuvanted vaccine of 30 μg
Experimental
split-virion, non-adjuvanted H1N1 vaccine of 30 μg.
干预措施: split-virion, non-adjuvanted H1N1 vaccine of 30 μg (Biological)
split-virion, non-adjuvanted vaccine of 45 μg
Experimental
split-virion, non-adjuvanted H1N1 vaccine of 45 μg.
干预措施: split-virion, non-adjuvanted H1N1 vaccine of 45 μg (Biological)
Placebo control
Placebo Comparator
Placebo control
干预措施: Placebo control (Biological)
结局指标
主要结局
Hemagglutination inhibition antibody titer
时间窗: Day 180
次要结局
- occurrence of solicited local and systemic adverse events after vaccination(Days 0-42)
研究者
研究点 (1)
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