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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01682369
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 diary cards, understanding of study procedure, consent process, availability at visits)
* Written informed consent obtained from parent / LAR (s) of the subject
* Age from 14 months to 26 months (from start of 14 months up to \& excluding 27 months of age)
* Subject is healthy as determined by medical history and clinical examination
* Have received the standard UK immunisation schedule
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).
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Months
Maximum Age:
26 Months
Study:
NCT01682369
Study Brief:
Protocol Section:
NCT01682369