A Double-blind,Randomized,Positive-controlled, Non-inferiority Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Chinese Subjects Aged 3 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,664
- 试验地点
- 1
- 主要终点
- incidence of solicited adverse reactions after vaccination
研究概览
简要总结
Influenza is an acute respiratory disease caused by influenza viruses. There are three types of the virus including A, B and C. Both type A and type B viruses can cause acute febrile respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough, sore throat, nasal congestion and general malaise. The main transmission of influenza is through those highly contagious aerosol droplets containing influenza virus passed from infected people to susceptible population. Each year in the fall and winter infection of influenza is widespread in various age groups, with high incidence rate. Although influenza is generally a self-limiting disease, but in children, the elderly (especially those above 65 years old and those with chronic heart, lung, kidney, liver, blood or metabolic diseases such as diabetes or other certain diseases) and those with poor immunity function, influenza can easily lead to serious flu complications such as pneumonia, resulting in severe increase of morbidity and mortality.
In order to evaluate safety and immunogenicity of a quadrivalent influenza vaccine produced by Jiangsu Jindike Biotechnology Co., Ltd. a phase III clinical trial is planned to conduct in healthy Chinese subjects aged 3 years and older.
详细描述
Subjects will be randomized into three arms- Experimental Group, Active Comparator A and Active Comparator B by the ratio of 2:1:1.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Aged 3 years and older
- •Healthy subjects judged from medical history and clinical examination
- •Subjects themselves or their guardians able to understand and sign the informed consent
- •Subjects themselves or their guardians can and will comply with the requirements of the protocol
- •Subjects with temperature <=37.0°C on axillary setting
排除标准
- •Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- •Any prior administration of influenza vaccine in last 6 month
- •Subject who is allergic to any ingredient of the vaccine
- •Female subject aged ≥18 years with a positive result after urine pregnancy test or during pregnancy or baby nursing period
- •Subject with damaged or low immune function which has already been known
- •Subject who had a seasonal influenza medical history in last 6 months
- •Subject with acute febrile illness or infectious disease
- •Major congenital defects or serious chronic illness, including perinatal brain damage
- •Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
- •Subject who has serious allergic history
- •Subject with other medical history not suitable for vaccination such as fainting during injection
- •Any prior administration of immunodepressant or corticosteroids in last 6 months
- •Any prior administration of blood products in last 3 months
- •Any prior administration of other research medicine/vaccine in last 30 days
- •Any prior administration of any attenuated live vaccine in last 30 days
- •Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- •Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent
结局指标
主要结局
incidence of solicited adverse reactions after vaccination
时间窗: 0-7 days after vaccination
incidence of solicited adverse reactions (including systemic and local adverse reactions) after vaccination
the 95% confidence interval (CI) lower limit for the seroconversion against each corresponding flu strain after vaccination is≥40% in subjects aged 3-59 years and≥30% in subjects aged ≥60 years separately
时间窗: 28 days after vaccination
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
次要结局
- the 95% CI lower limit for the post-vaccination seroprotection rates against each corresponding flu strain is ≥70%(28 days after vaccination)
- the post-vaccination mean geometric increases (GMIs) of HAI titer against each corresponding flu strain is≥2.5 in subjects aged 3-59 years and≥2.0 in subjects aged ≥60 years separately(28 days after vaccination)
- incidence of unsolicited adverse reactions after vaccination(0-28 days after vaccination)
- incidence of serious adverse event (SAE) after vaccination(29 days to 6 month after vaccination)