EUCTR2007-003786-41-DE进行中（未招募）不适用
A Phase III, randomized, observer-blind, controlled, multi-center clinical study to evaluate the efficacy, safety and immunogenicity of one and two intramuscular doses of FLUAD versus control vaccines in unprimed healthy subjects aged between 6 and up to 72 months.
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 3,500 人开始时间: 2007年7月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,500
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
- •1) Children of 6 to <36 months of age, whose parents/legal guardians have given written informed consent prior to study entry,
- •2) In good health as determined by:
- •a.medical history,
- •b.physical examination,
- •c.clinical judgment of the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1) Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. All routine vaccines should be given according to local recommendations: routine vaccines or any other vaccines not foreseen in the protocol can be given after the active trial phase (i.e. 3 weeks after last vaccination in the respective season) has been concluded.
- •2) Receipt of another investigational vaccine or any investigational agent within 30 days prior to study start.
- •3) Administration of any other investigational agent (other than the study vaccine) throughout the entire study period.
- •4) Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable).
- •5) Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 2 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
- •6) Fever (defined as axillary temperature = 38°C/rectal temperature = 38.5°C) within the 2 days before enrollment
- •7) Any serious disease including, for example:
- •b.autoimmune disease (including rheumatoid arthritis),
- •c.diabetes mellitus,
- •d.chronic pulmonary disease,
- •e.acute or progressive hepatic disease,
- •f.acute or progressive renal disease
- •8) Known or suspected impairment/alteration of immune function, for example, resulting from:
- •a.receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy),
- •b.receipt of immunostimulants,
- •c.receipt of parenteral immunoglobulin preparation, blood products, and/or
- •plasma derivatives within the past 3 months and for the full length of the
- •d.high risk for developing an immunocompromising disease
- •9) Bleeding diathesis
- •10) History of hypersensitivity to any component of the study medication or chemically related substances
- •11) History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component
- •12) Laboratory confirmed influenza disease in the past 6 months
- •13) History of neurological disorder or seizures (febrile seizures allowed)
- •14) Ever received any influenza vaccine
- •15) Major surgery planned during the study period
- •16) Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
研究者
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