EUCTR2015-001648-12-GB进行中（未招募）1 期
A phase II, open label trial to describe immune and transcriptional responses to MF59 adjuvanted trivalent influenza vaccine (ATIV) in 13-24 month healthy children and adults 18-65 years - ADITEC Flu2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入选标准
- •The investigator believes that the parents / LAR (s) of the child can and will comply with requirements of the protocol (e.g. completion of electronic diary, understanding of study procedure, consent process, availability at visits) and have internet access for the duration of the study.
- •Written informed consent obtained from parent / LAR (s) of the subject
- •Age from 13 months up to 24 months (excluding 24 months + 0 days and older) at time of V1 (first immunisation visit)
- •Born to two caucasian parents
- •Participant is healthy as determined by medical history and clinical examination
- •Have received all the vaccines specified in the UK immunisation schedule
- •Written and informed consent obtained from participant
- •Age 18 years to 65 years (excluding 65 years +0 days and older)
- •Participant has internet access for the duration of the study
- •Participant is healthy as determined by medical history and clinical examination
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Child in care
- •Use (or planned use) of any non-registered or investigational product in last 30 days
- •Previous influenza vaccination
- •Microbiologically proven influenza illness or treatment with antiviral medications
- •Confirmed or suspected egg allergy
- •Chronic serious medical conditions which may, in the opinion of the investigator, interfere with evaluation of study objectives e.g. chronic lung disease, chronic liver/renal disease, chronic renal failure chronic heart disease, congenital genetic syndromes (e.g. Trisomy 21).
- •Recommended for influenza vaccine in UK (eg. Children in clinical risk groups as specified by Public Health England)
- •Suspected or confirmed immunosuppressive or immunodeficiency conditions (including splenic dysfunction & HIV)
- •Autoimmune conditions e.g. Type 1/2 diabetes mellitus, thyroid disease, juvenile idiopathic arthritis etc
- •Bleeding disorders
- •Use (or planned use) of any non-registered or investigational product in last 30 days
- •Confirmed or suspected egg allergy
- •Chronic serious medical conditions which may, in the opinion of the investigator, interfere with evaluation of study objectives e.g. chronic lung disease, chronic liver/renal disease, chronic renal failure chronic heart disease
- •Prior receipt of the 2015/2016 influenza vaccine
- •Recommended for influenza vaccine in UK (eg. in clinical risk groups as specified by Public Health England)
- •Suspected or confirmed immunosuppressive or immunodeficiency conditions (including splenic dysfunction & HIV)
- •Autoimmune conditions e.g. Type 1/2 diabetes mellitus, thyroid disease, juvenile idiopathic arthritis etc
- •Bleeding disorders
- •Temporary Delay to first study intervention (children and adults)
- •Participants who have experienced fever (=38.0°C) or coryzal symptoms within the 24 hours prior to first study intervention
- •Use of systemic steroids for more than 1 week e.g. prednisolone >0.5mg/kg/day in the 3 months prior to first study intervention
- •Chronic administration (=14 days in total) of immunosuppresants or other immune modifying drugs in the 3 months prior to first study intervention
- •Immunisation with inactivated vaccines within the week prior to first study intervention, or live vaccines within the 3 weeks prior to first study intervention
- •Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation in the 3 months prior to first study intervention
- •Receipt of antipyretics within 6 hours prior to immunization
研究者
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