A Random, Double-Blind, Multicenter, Positive Control and Placebo Control Phase Two Trail to Evaluate the Safety and Immunogenicity of Live Attenuated Influenza Vaccine in 3-59y Healthy People
试验速览
- 阶段
- 2 期
- 入组人数
- 2,520
- 试验地点
- 1
- 主要终点
- The number of participants with positive sIgA as assessed by SAS v9.4
研究概览
简要总结
Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase two trail is to evaluate the immunogenicity of LAVI (non freeze- dried). The secondary objective is to evaluate the safety of LAVI (non freeze- dried).
详细描述
Totally 2520 health people aged 3-59 years old will be divided into two age group, containing 1260 in 18-59 years old and 1260 in 3-19 years old. All subjects will receive vaccination either LAVI(non freeze- dried), LAVI(freeze- dried) or placebo in a ratio of 2:2:1.
All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation. All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.
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
- Single (Participant)
盲法说明
The design of this trail is based on random, one-blind, placebo control. The subjects will not know the masking status, unless the specific subjects who required treatment for serious adverse events .
入排标准
- 年龄范围
- 3 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged in 3-59 years old
- •Had not received vaccination of Influenza vaccine in the past one year
- •Had not infected with Influenza virus
- •This trail has been agreed by volunteers or his/her legal guardian
- •Volunteers or his/her legal guardian will fellow this trail protocol
排除标准
- •People with fever before vaccination, temperature higher than 37.0 #
- •Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant
- •People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination
- •According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials
- •Acute infectious disease or acute attack of chronic disease before inoculation
- •People get any vaccine within 14 days before the trial
- •People in immune deficiency or diagnosed with congenital or acquired immunodeficiency, people with immunosuppressive therapy in the past six months
- •People with epilepsy or a history of mental illness
结局指标
主要结局
The number of participants with positive sIgA as assessed by SAS v9.4
时间窗: within 10 days after vaccination
The Mucosal convention rate of sIgA in all subjects
次要结局
未报告次要终点