A Random, Double -Blind, Placebo Control Phase Ⅰ Trail to Evaluate the Safety and Immunogenicity of Live Attenuated Influenza Vaccine in 3-59y Healthy People
试验速览
- 阶段
- 1 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events 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 Ⅰ trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).
详细描述
Totally 160 health people aged 3-59 years old will be divided into two age group, containing 80 in 18-59 years old and 80 in 3-19 years old. All subjects will receive vaccination either LAVI or placebo in a ratio of 3:1.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The design of this trail is based on random, two-blind, placebo control. The subjects and investigators 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 half of years.
- •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 from 18-59 age group with abnormal laboratory index. (slight abnormality is except if judged with no clinical significance by doctors.)
- •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
Number of participants with adverse events as assessed by SAS v9.4
时间窗: Within 31 days after vaccination
The incidence rate of adverse events in all subjects
Number of participants with laboratory examination abnormity as assessed by SAS v9.4Clinical laboratory examination
时间窗: 3 days after vaccination
The incidence rate of abnormal of Blood routine, blood biochemical and urine in The incidence rate of abnormality of blood routine, blood biochemical and urine routine in 18-59 years age group
Number of participants with virus Shedding as assessed by SAS v9.4
时间窗: within 16 days after vaccination
The nasal secretions of Subjects in 18-59 years age group will be taken and be tested
次要结局
未报告次要终点