Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Post-vaccination HI antibody titre
研究概览
简要总结
This is a single blind, reference drug controlled, one center viral immunogenicity and tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos antigen content to assess immunogenicity and tolerability.
The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004 trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability of the study drug according to CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult volunteers in good health aged over 18 years, both sexes;
- •Full contractual capacity of the participants;
- •Are in good health (as determined by vital signs and medical history);
- •Negative urine or serum pregnancy test for females of childbearing potential;
- •Are able to understand and comply with planned study procedures;
- •Signed informed consent prior to initiation of study procedures;
- •Absence of existence of any exclusion criteria.
排除标准
- •Known allergy to eggs or other components of the vaccine;
- •History of Guillain-Barré syndrome;
- •Pregnancy or breast feeding or positive pregnancy test prior to vaccination;
- •Immunosuppressive therapy in the preceding 36 months;
- •Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
- •Concomitant corticosteroid therapy, including inhaled corticosteroids;
- •Psychiatric illness and/or concomitant psychiatric drug therapy;
- •Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
- •Vaccine therapy within 4 weeks prior to the study;
- •Influenza vaccination within 6 months prior to the study;
- •Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response;
- •Documented HIV, HBV or HCV infection;
- •Acute febrile respiratory illness within one week prior to vaccination;
- •Experimental drug therapy within 1 month prior to vaccination;
- •Alcohol or drug abuse.
结局指标
主要结局
Post-vaccination HI antibody titre
时间窗: 21-28 days after vaccination
Incidence of adverse reactions
时间窗: 21-28 days after vaccination
次要结局
- Post-vaccination HI antibody titer(110-120 days after vaccination)