NCT07545564Enrolling By Invitation4 期
A Study on Nasal Mucosal Specific IgA Antibody Levels and Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Membrane-specific sIgA antibody
研究概览
简要总结
Mucosal-specific sIgA antibody GMT;Evaluate the achievement of 2-fold and 4-fold increases in the geometric mean titer (GMT) of specific nasal mucosal sIgA antibodies after 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
- Double (Participant, 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
- •People aged 3 to 17 years old who voluntarily receive the live attenuated influenza nasal spray vaccine;
- •The participant themselves can comply with the protocol requirements and complete sample collection;
- •Obtain the consent of the participants' guardians and sign the informed consent form;
排除标准
- •Axillary temperature > 37.0°C on the day of enrollment;
- •Received any influenza vaccine within the past 2 years and plans to receive other influenza vaccines during the trial period;
- •Clinically diagnosed with influenza in a medical institution within the past year (with confirmed etiological diagnosis);
- •Individuals with known hypersensitivity to any ingredient contained in this product, including eggs, excipients, and gentamicin sulfate;
- •Individuals suffering from acute diseases, severe chronic diseases, acute exacerbations of chronic diseases, and fever;
- •Pregnant women;
- •Patients with Leigh syndrome who are being treated with aspirin or aspirin-containing medications;
- •Individuals with immunodeficiency or those undergoing immunosuppressive therapy;
- •Individuals with uncontrolled epilepsy and other progressive neurological diseases, or those with a history of Guillain-Barré syndrome;
- •Nasal abnormalities that, in the judgment of a clinician, may affect vaccination, individuals in the medication period for allergic rhinitis, or those currently receiving nasal spray administration;
- •Having received a live attenuated vaccine within 14 days prior to enrollment, or a subunit or inactivated vaccine within 7 days prior to enrollment;
- •Presence of other factors deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
Placebo
Placebo Comparator
sterile water
干预措施: Placebo (Biological)
Vaccine
Experimental
LAIV
干预措施: LAIV (Biological)
结局指标
主要结局
Membrane-specific sIgA antibody
时间窗: 14days after vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Studying the LAIV induced Immune respOnse in the Nasopharynx of young children.Influenza2024-513933-18-00Leids Universitair Medisch Centrum (LUMC)20
招募中
3 期
IPAD Trial2024-513124-41-00Universitair Medisch Centrum Utrecht100
招募中
不适用
Analysis of the Specificity and Persistence of Nasal Immune Responses to Respiratory Viral Antigens in Immunocompromised and Healthy CohortsNCT07295535Fondazione IRCCS Policlinico San Matteo di Pavia40
尚未招募
2/3 期
Effectiveness of Lauq Rumman in the treatment of Nazla Harr (Allergic Rhinitis)CTRI/2024/09/073459State Unani Medical College and HAHRDM Hospital40
Unknown
不适用
S.parasanguinis_B 在儿童过敏性鼻炎过敏原特异性免疫治疗中的作用及其作为新型生物标志物的研究过敏性鼻炎ChiCTR2600122448福建省自然科学基金项目（项目编号：2025J011202）62