EUCTR2015-001648-12-GB
Active, not recruiting
Phase 1
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
ConditionsThis trial is investigating healthy children and adult's gene expression and immune response to the Fluad (MF59)-adjuvanted trivalent influenza vaccine and also comparing these to the local and general reactions following vaccine administration. Healthy children will be immunised with 2 doses, adult with 1 dose.Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsFluad
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- This trial is investigating healthy children and adult's gene expression and immune response to the Fluad (MF59)-adjuvanted trivalent influenza vaccine and also comparing these to the local and general reactions following vaccine administration. Healthy children will be immunised with 2 doses, adult with 1 dose.
- Sponsor
- niversity of Oxford
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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