Aditec Flu 2 Study: Understanding the genetic basis for immune responses to flu vaccines in children and adults

Phase 1

• 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.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-001648-12-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Children:
•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

Adults:
•Written and informed consent obtained from participant
•Age 18 years to 65 years (excluding 65 years +0 days and older)
•Caucasian
•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

Exclusion Criteria

Children
•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

Adults
•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
•Pregnancy

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified