NCT04363359已完成2 期
Immunogenicity and Safety of Quadrivalent Influenza Vaccine In 6 to 35 Months Population: a Randomized, Double-blind, Parallel-group Ⅱ Phase of Clinical Trials
Shanghai Institute Of Biological Products1 个研究点 分布在 1 个国家目标入组 1,980 人开始时间: 2020年1月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,980
- 试验地点
- 1
- 主要终点
- seroconversion rate of HI antibodies
研究概览
简要总结
To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III clinical trials.
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
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants aged 6-35 months.
- •Volunteer legal guardian or client informed consent, voluntarily participate in and sign informed consent.
- •The volunteer legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.
排除标准
- •The underarm body temperature on the day of enrollment was > 37.0℃.
- •Have been suffering from influenza within the previous 3 months (confirmed by either clinical, serological or microbiological methods).
- •Any previous influenza vaccination (registered or experimental) within 6 months or any planned influenza vaccination during the study period.
- •Allergic to any component of the vaccine, a history of allergic reactions to eggs or gentamicin sulfate.
- •A history of severe allergy to any vaccine or drug.
- •Preterm birth (delivered before 37 weeks of gestation), low birth weight baby (birth weight < 2300g for girls, <2500g for boys).
- •Dystocia, asphyxia rescue, nervous system damage history;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
- •A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
- •Patients who received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
- •Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- •History of asthma, past two years of instability requiring emergency treatment, hospitalization, intubation, oral or intravenous administration of corticosteroids;
- •Have received blood or blood-related products;
- •A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or a family history;
- •A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
- •Planning to relocate before the end of the study or to leave for an extended -period during the scheduled study visit;
- •Participating in or planning to participate in other clinical trials in the near future;
- •The investigators determined that any conditions were inappropriate to participate in the clinical trial.
结局指标
主要结局
seroconversion rate of HI antibodies
时间窗: 56 days
28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroconversion rate of HI antibodies against any subtype of influenza virus in each group.
seroprotection rate of HI antibodies
时间窗: 56 days
28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroprotection rate of HI antibodies against any subtype of influenza virus in each group.
GMT and GMI of HI antibodies
时间窗: 56 days
28 days after receiving two doses of vaccine in subjects aged 6-35 months, GMT and GMI of HI antibodies against any subtype of influenza virus in each group.
次要结局
- Reactogenicity Events(30 days and 6 months)
研究者
研究点 (1)
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