此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

2013年3月13日 更新者:Sinovac Biotech Co., Ltd

A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants

A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).

研究概览

研究类型

介入性

注册 (实际的)

310

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Guangxi
      • Guilin、Guangxi、中国
        • GuangXi Center for Diseases Control and Prevention

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

6个月 至 2年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Healthy male or female aged between 6 and 35 months
  2. Full-term birth, birth weight 2,500 grams or more
  3. provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent

Exclusion Criteria:

  1. Cases, cured cases and close contact of influenza A (H1N1) virus
  2. 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
  3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  4. Symptoms of acute infection within a week
  5. Autoimmune disease or immunodeficiency
  6. Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
  7. 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
  8. 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
  9. History or family history of convulsions, epilepsy, brain disease and psychiatric
  10. Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
  11. Guillain-Barre Syndrome
  12. Administration of 2009-2010 seasonal vaccine
  13. History of any blood products within 3 months
  14. Administration of any other investigational research agents within 30 days
  15. Administration of any live attenuated vaccine within 30 days
  16. Administration of subunit or inactivated vaccines within 14 days
  17. Be receiving anti-TB prophylaxis or therapy currently
  18. Axillary temperature > 37.0 centigrade at the time of dosing
  19. 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

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:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine
120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
实验性的:Group 2 : 15 μg pandemic influenza A/H1N1 vaccine
120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
假比较器:Group 3 : 7.5 μg seasonal trivalent vaccine
60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart
Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants
大体时间:3 months
3 months

次要结果测量

结果测量
大体时间
Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants
大体时间:3 months
3 months

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2009年12月1日

初级完成 (实际的)

2010年3月1日

研究完成 (实际的)

2010年5月1日

研究注册日期

首次提交

2010年1月11日

首先提交符合 QC 标准的

2010年1月11日

首次发布 (估计)

2010年1月12日

研究记录更新

最后更新发布 (估计)

2013年3月15日

上次提交的符合 QC 标准的更新

2013年3月13日

最后验证

2013年3月1日

更多信息

与本研究相关的术语

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.

订阅