ADITEC FLU STUDY: Understanding the genetic basis for immune responses to flu vaccines
- Conditions
- Healthy children will be immunised with two vaccines against influenza: Agrippal or Imuvac, or Fluad to study the immune responses to immunisation at a genetic level.Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-002443-26-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method