NCT02708173已完成1 期
Safety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older
Beijing Chaoyang District Centre for Disease Control and Prevention1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The rate of adverse reactions of Quadrivalent Influenza Virus Vaccine
研究概览
简要总结
This study evaluates the safety of Quadrivalent Influenza Virus Vaccine in Healthy People Aged years 3 to 60.40 Subjects will be equally divided into 2 groups,including 3-17 years old and 18-60 years old.Adult group first receive one dose of Quadrivalent Influenza Virus Vaccine.Then minors group also receive one dose of Quadrivalent Influenza Virus Vaccine after 7 days.
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
- 3 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects more than 3 years old, and the subjects can be informed consent, and sign the informed consent.
- •the subjects and his guardians can obey the demands of the scheme .
- •Axillary temperature less than 37℃
排除标准
- •The people who has a vaccine allergies, or who allergic to any kind of composition in experimental vaccine, such as eggs,ovalbumin etc.
- •The people who has serious side effects to vaccine, such as allergy,urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
- •the subject who has symptoms of acute infection within a week.
- •Autoimmune diseases or Immune function defect, people has immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
- •People has congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
- •People has asthma Unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
- •Diagnosed abnormal coagulation(Lack of clotting factors,Clotting disorders,Platelet abnormality) or significant bruising or coagulopathy
- •people has history or family history of convulsions, seizures, encephalopathy and psychiatric.
- •alienia, functional asplenia, and alienia or splenectomy in any situation.
- •Serious neurological disorders such as Green Barry syndrome.
- •people who has received blood products or immunoglobulin products in the past one months.
- •people who has received other study drug in the past one month.
- •people who received live attenuated vaccine, subunit vaccine or inactivated vaccine.
- •people who has received allergy treatment in in the past 14 days.
- •People who is on anti-TB treatment.
- •People whose axillary temperature is more than 37℃ before the vaccination.
- •People who is pregnant.
- •Any factors unsuitable for clinical trail according to the researchers.
结局指标
主要结局
The rate of adverse reactions of Quadrivalent Influenza Virus Vaccine
时间窗: 3 months
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
次要结局
未报告次要终点
研究者
研究点 (1)
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