Multi-center, Randomized, Double-blind, Placebo-controlled Trial of a Live Attenuated Influenza Vaccine in People Aged 3-17
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 6,080
- 试验地点
- 1
- 主要终点
- Primary influenza protective effect endpoint
研究概览
简要总结
To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.
To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.
详细描述
Main end point:
Primary influenza protective effect endpoint Protective effect of 14 days on laboratory-confirmed influenza cases. Protective effect of 14 days after receiving lyophilized nasal spray live attenuated influenza vaccine on laboratory-confirmed serotype influenza cases.
Secondary endpoints:
Secondary point of secondary endpoint Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 0 days later on laboratory-confirmed influenza cases.
Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days later on clinically diagnosed influenza cases.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Local residents aged between 3 and 17;
- •People who signed the informed consent form and could actively cooperate with the study；
- •Axillary body temperature of 37.0℃.
排除标准
- •Subjects who meet the contraindications and precautions specified in the vaccine instructions:
- •Those known to be allergic to any ingredients of this product, including eggs, excipients, gentamycin sulfate;
- •Patients with acute disease, severe chronic disease, the acute onset of chronic disease and fever;
- •Women in pregnancy;
- •Patients with Leigh syndrome treated with aspirin or aspirin-containing drugs;
- •Immunodeficient, immunocompromised, or under immunosuppressive therapy;
- •Patients with uncontrolled epilepsy and other progressive neurological diseases, patients with a history of Guillain-Barre syndrome; And g. patients with rhinitis (with a clear diagnosis and in the onset of rhinitis).
- •Have received other clinical study drugs or were participating in other clinical trials within 1 month before entering the cohort.
- •Have received any influenza vaccine during this natural year before entering the study
- •Those who have been diagnosed with influenza in this natural year before entering the study.
- •Any condition that the investigator judged to affect the trial.
研究组 & 干预措施
Placebo group
Sterile water for inhalation
干预措施: Sterile water for inhalation (Other)
结局指标
主要结局
Primary influenza protective effect endpoint
时间窗: 7 months
Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days on the incidence of laboratory-confirmed influenza cases
次要结局
- Safety(One month)
- Study on detoxification(15 days)
- Secondary protective efficacy endpoint(Seven months)