Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 15 μgHA/Strain/0.5mL) for the Use in the Season 2013/2014 in Adult and Elderly Subjects

Fluart Innovative Vaccine Ltd, Hungary3 个研究点分布在 1 个国家目标入组 120 人开始时间: 2013年8月22日最近更新: 2021年4月5日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Fluart Innovative Vaccine Ltd, Hungary
入组人数: 120
试验地点: 3
主要终点: Change in Geometric Mean Titre Ratio, A/H1N1 Strain

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.

详细描述

Aim of the study:

To assess immunogenicity and safety of Fluval AB seasonal influenza vaccine with 3 x 15 μgHA active ingredient in two age groups (18-59 years and ≥60 years) in accordance with CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997

Primary objective:

Methods:

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 99 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Adult persons aged 18 to 59 years, elderly persons aged ≥60 years from both sexes, mentally competent;
•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;
•Female volunteers aged 18-59 years (i.e. participants of childbearing potential) with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study;
•Capability of participants to understand and comply with planned study procedures;
•Participants provide written Informed Consent (IC) prior to initiation of study procedures;
•Absence of existence of any

排除标准

•Exclusion Criteria:
•Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
•Known hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin, vancomycin or any other component of the vaccine;
•History of Guillain-Barré syndrome;
•History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
•Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure;
•Immunosuppressive therapy within 36 months prior to vaccination;
•Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
•Receipt of immunostimulants;
•Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination;
•Suspected or known HIV, HBV or HCV infection;
•Acute disease and/or axillary temperature ≥37oC within 3 days prior to vaccination;
•Vaccine therapy within 4 weeks prior to vaccination;
•Influenza vaccination (any kind) within 6 months prior to vaccination;
•Experimental drug therapy within 4 weeks prior to vaccination;
•Concomitant participation in another clinical study;
•Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study;
•Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have effect on the objective decision-making of the volunteer;
•Alcohol or drug abuse of the participant.

研究组 & 干预措施

Age group 1: adults (18-59 years)

Experimental

Intervention: Vaccination with Fluval AB suspension for injection.

Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.

干预措施: Vaccination with Fluval AB suspension for injection (Biological)

Age group 2: elderly (> 60 years)

Experimental

Intervention: Vaccination with Fluval AB suspension for injection.

Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.

干预措施: Vaccination with Fluval AB suspension for injection (Biological)