A phase II, multi-centre, open labelled randomised control trial to describe immune & transcriptomic responses to trivalent inactivated vaccine (TIV) & MF59 adjuvanted influenza vaccine (ATIV) in 14 -26 month healthy children - ADITEC FLU STUDY: Understanding the genetic basis for immune responses

niversity of Oxford0 个研究点目标入组 90 人开始时间: 2012年7月13日最近更新: 2019年6月30日

试验速览

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•All of the following criteria need to be met to participate in the study:
•1.The investigator believes that the parents / legal authorised representative(s) (LARs) of the child can and will comply with requirements of the protocol (e.g. completion of diary cards, understanding of study procedure, consent process, availability at visits)
•2.Written informed consent obtained from parent / LAR (s) of the subject
•3.Age from 14 months to 26 months (from start of 14 months up to & excluding 27 months of age)
•4.Subject is healthy as determined by medical history and clinical examination
•5.Has received standard UK immunisation schedule
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•A participant cannot participate if any of the following criteria are met:
•1. The child is in care
•2. Use or planned use of any non-registered or investigational product in last 30 days
•3. Previous influenza vaccination
•4. Microbiologically proven influenza illness or treatment with antiviral medications
•5. Confirmed or suspected egg allergy or allergic reaction to previous vaccinations.
•6. 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).
•7. Suspected or confirmed immunosuppressive or immunodeficiency conditions (including splenic dysfunction & HIV)
•8. Autoimmune conditions e.g. Type 1/2 diabetes mellitus, thyroid disease, juvenile idiopathic arthritis etc.
•9. Bleeding disorders

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