Post-marketing Clinical Observation of Hualan's Inactivated Influenza Vaccine: A Single Center, Parallelled, Controlled, Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse reactions as a measure of safety study
研究概览
简要总结
Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008.
In order to further investigate the safety and immunogenicity of the vaccine in the market, The clinical observation was planned to be conducted in Mianyang city (Yanting County), Sichuan Province, China.
详细描述
Dosage and administration route in this clinical trial:
Subjects age 3 years or older was vaccinated following a single 0.5ml dose immunization regime.
The preferred site of injection was the at the skin near outboard deltoid muscle of the upper arm.
The administration route is after the sanitization with 75% alcohol, intramuscularly inject the test vaccine or the control vaccines when the skin was slightly dried for those subjects complied with the inclusion requirements.
Safety indicators:
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
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female age 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
- •Healthy male or female by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product;
- •Be able to comply with the requirement of clinical trial protocol;
- •Have no history of vaccination within the past 6 months and vaccination with other product within the latest 1 week;
- •Axillary temperature <37.1℃.
排除标准
- •Subject that was allergic to eggs and any component of the vaccine, or has history of other allergy;
- •Fever, acute disease or acute onset of chronic disease and influenza;
- •Guillain-Barre Syndrome
结局指标
主要结局
Number of subjects with adverse reactions as a measure of safety study
时间窗: 28 days after the vaccination
Local reactions, systemic reactions, severity degree and AEFI correlation
次要结局
- Observation of the immunological effect(28 days after the immunization)