Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.
详细描述
This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated.
Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 to 36 months, both sexes;
- •Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study;
- •Capability of the legitimate representative of the volunteer to understand and comply with planned study procedures;
- •Legitimate representative of the volunteer provide written informed consent prior to initiation of study procedures;
- •Absence of existence of any
排除标准
- •Exclusion Criteria:
- •Known allergy to eggs or other components of the vaccine (in particular mercury);
- •History of Guillain-Barré syndrome;
- •Active neoplasm;
- •Former or on-going immunosuppressive therapy;
- •Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
- •Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
- •Documented HIV, HBV or HCV infection;
- •Chronic illness that, in the opinion of the investigator, may have effect on the participation in the study;
- •Acute febrile respiratory illness within one week prior to vaccination;
- •Vaccine therapy within 4 weeks prior to vaccination;
- •Influenza vaccination within 6 months prior to vaccination;
- •Experimental drug therapy within 1 month prior to vaccination;
- •Past or current psychiatric disease of the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the legitimate representative;
- •Alcohol or drug abuse of the legitimate representative.
研究组 & 干预措施
Vaccination with Fluval P
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose.
干预措施: Vaccination with FLUVAL P (Biological)
结局指标
主要结局
Incidence of adverse events
时间窗: 28 days after vaccination
To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination.
次要结局
- Incidence of adverse events(180-210 days after vaccination)
- Efficacy of the study drug(180-210 days after vaccination)