NCT01047202已完成4 期
A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female aged between 6 and 35 months
- •Full-term birth, birth weight 2,500 grams or more
- •provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent
排除标准
- •Cases, cured cases and close contact of influenza A (H1N1) virus
- •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
- •Symptoms of acute infection within a week
- •Autoimmune disease or immunodeficiency
- •Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
- •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 or family history of convulsions, epilepsy, brain disease and psychiatric
- •Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
- •Guillain-Barre Syndrome
- •Administration of 2009-2010 seasonal vaccine
- •History of any blood products within 3 months
- •Administration of any other investigational research agents within 30 days
- •Administration of any live attenuated vaccine within 30 days
- •Administration of subunit or inactivated vaccines within 14 days
- •Be receiving anti-TB prophylaxis or therapy currently
- •Axillary temperature > 37.0 centigrade at the time of dosing
- •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
研究组 & 干预措施
Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine
Experimental
120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart
干预措施: Pandemic influenza A/H1N1 vaccine (Biological)
Group 2 : 15 μg pandemic influenza A/H1N1 vaccine
Experimental
120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart
干预措施: Pandemic influenza A/H1N1 vaccine (Biological)
Group 3 : 7.5 μg seasonal trivalent vaccine
Sham Comparator
60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart
干预措施: Seasonal trivalent vaccine (Biological)
结局指标
主要结局
Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants
时间窗: 3 months
次要结局
- Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants(3 months)
研究者
研究点 (1)
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