Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02529904
Eligibility Criteria:
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 from 18 years up to 65 years (excluding 65 yrs + 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
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Months
Maximum Age:
65 Years
Study:
NCT02529904
Study Brief:
Protocol Section:
NCT02529904