NCT07133802尚未招募3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine in Adults Aged 18-59 Years
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 6,680
- 主要终点
- Protective Efficacy
研究概览
简要总结
A Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination
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)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants aged 18-59 years
- •Capable of providing informed consent in person
- •Willing and able to comply with all clinical trial requirements
排除标准
- •Axillary temperature >37.0°C on enrollment day *
- •Received any influenza vaccine within the past 6 months or plans to receive other influenza vaccines during the trial
- •History of laboratory-confirmed influenza (by clinical, serological, or microbiological methods) within the past 6 months
- •Female participants of childbearing potential with positive urine pregnancy test, currently breastfeeding, or planning pregnancy within 6 months
- •Acute phase of any infectious disease/chronic illness within 3 days, or recent use (≤3 days) of antipyretics/analgesics/antihistamines *
- •History of severe allergies requiring medical intervention (e.g., anaphylaxis, angioedema, Arthus reaction) or hypersensitivity to vaccine components (egg proteins, gentamicin sulfate, etc.)
- •Known malignancies, autoimmune diseases (e.g., SLE, rheumatoid arthritis), or immunodeficiency (HIV, organ transplantation, etc.)
- •Asplenia, functional asplenia, or any splenectomy history
- •Use of immunosuppressants/immunomodulators (e.g., systemic corticosteroids >14 days) within 6 months or planned use during study
- •Congenital anomalies affecting organ function, uncontrolled hypertension (≥140/90 mmHg despite treatment), or severe hepatic/renal diseases (e.g., diabetes-complicated)
- •Active asthma or clinical remission for <12 months
- •History or family history of neurological/psychiatric disorders (e.g., epilepsy, Guillain-Barré syndrome)
- •Salicylate use (e.g., aspirin) within 30 days or planned use within 6 weeks post-vaccination
- •Nasal abnormalities potentially affecting vaccine administration (e.g., active allergic rhinitis with medication, ongoing nasal sprays)
- •Blood products/immunoglobulin administration within 3 months or planned use during trial
- •Live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment *
- •Participation in other clinical trials within 1 month or concurrent involvement in interventional studies
- •Any condition deemed by investigators to compromise trial integrity
研究组 & 干预措施
Nasal Spray Live Attenuated Influenza Vaccine
Experimental
干预措施: Test Group (Biological)
Placebo
Placebo Comparator
干预措施: Placebo Group (Biological)
结局指标
主要结局
Protective Efficacy
时间窗: at 14 days post-vaccination
To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed influenza in participants aged 18-59 years at 14 days post-vaccination
次要结局
- Protective Efficacy(Throughout the entire study period)
- Safety(Day 15 post-vaccination)
研究者
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