EUCTR2013-003449-40-HU进行中（未招募）1 期
Immunogenicity and Tolerability Study of FLUVAL AB Novo Suspension for Injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 µg HA/strain/0.5 ml) for Children and Adolescents
Omninvest Ltd.0 个研究点目标入组 120 人开始时间: 2013年8月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Children aged 3 to 12 years, adolescents aged 12 to 18 years from 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;
- •Female volunteers 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 adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures;
- •Adolescent participants aged 12 to 18 years and legitimate representative of all volunteers provide written Informed Consent (IC) prior to initiation of study procedures;
- •Absence of existence of any exclusion criteria.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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, 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 or the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the volunteer;
- •Alcohol or drug abuse of the participant or the legitimate representative.
研究者
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