Safety Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and active surveillance.
研究概览
研究类型
介入性
注册 (实际的)
60
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 至 50年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- With the subject (or his guardian's) informed consent and signed the informed consent;
- The history, physical examination and clinical judgement were determined to be healthy and in accordance with the vaccination age of the product;
- The Subject or his guardian could comply with the clinical study protocol;
- Have not been inoculated with Meningococcal vaccine in the past six months and A + C meningococcal polysaccharide vaccine in the past two years;
- Have not been inoculated with other preventive biological products;
- Axillary temperature≤37.0 ℃.
Exclusion Criteria:
- Children with the history of Neisseria meningitis;
- Had allergies or serious adverse reactions of previous vaccination, such as allergies, urticaria, dyspnea, edema, abdominal pain, etc;
- Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the past 6 months (not including allergic rhinitis corticosteroid aerosol therapy, patients with acute non concurrent dermatitis surface corticosteroid therapy);
- Have been accepted blood products in the past 3 months;
- Have been inoculated with other research drugs or vaccines in the past month;
- Have been inoculated with attenuated live vaccine in the past 14 days;
- Have been inoculated with subunit or inactivated vaccine in the past 7 days;
- Had any acute illness, the need for systemic application of antibiotics or antiviral treatment in the past 7 days;
- Had fever in the past 3 days (axillary temperature≥38.0℃) ;
- Have been diagnosed with abnormal coagulation function (such as the lack of coagulation factors, coagulation disorders and abnormal blood platelet), obvious bruises or coagulation disorders by physician diagnosis;
- Had the history of thyroid resection or the need for treatment of thyroid diseases in the past 12 months;
- Asplenia, functional asplenia and asplenia or splenectomy of any situation;
- Had epilepsy, convulsions, encephalopathy, mental illness or family history;
- Suffering from serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, neurological disorders or Guillain-Barre syndrome);
- Suffering from known or suspected concurrent diseases including: respiratory diseases, acute or chronic infection of the activities, children's mother or the subject had HIV infection, cardiovascular disease, high blood pressure, during cancer treatment period, skin diseases;
- The female during her pregnant and lactation period or who plan to become pregnant during the trial.
- The subject of any other factors that are not suitable to participate in clinical trials according to the researcher's judgment.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:age of 18-50 years old
|
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.
|
|
实验性的:age of 7-17 years old
|
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.
|
|
实验性的:age of 2-6 years old
|
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The rate of adverse reactions of ACYW135 meningococcal polysaccharide vaccine
大体时间:28 days
|
Adverse reactions associated with vaccine will be observed in subjects after each 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
|
28 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年3月1日
初级完成 (实际的)
2016年7月1日
研究注册日期
首次提交
2016年8月11日
首先提交符合 QC 标准的
2016年8月11日
首次发布 (估计)
2016年8月15日
研究记录更新
最后更新发布 (估计)
2016年8月16日
上次提交的符合 QC 标准的更新
2016年8月15日
最后验证
2016年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.