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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT04222595
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. understanding of study procedure, consent process, availability at visits).
* Written informed consent obtained from parent(s)/LAR(s) of the subject
* Age from 4y+ 1day up to 6 years (until the day they turn 7y) at time of V1 (first immunisation visit)
* Born to two white Caucasian (of European descent) parents
* Participant is healthy as determined by general health assessment
* Have received all the vaccines specified in the UK immunisation schedule
* Group 1: Never received the intranasal flu vaccine before
* Group 2: Must have had at least 1 dose of the intranasal flu vaccine
* Group 3: Must have had at least 2 doses of the intranasal flu vaccine
* Group 4 : Must have had at least 3 or 4 doses of the internasal flu vaccine
Exclusion Criteria:
* Use (or planned use) of any non-registered or investigational product in 30 days before or after study vaccination
* 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 inactivated influenza vaccine in UK (e.g. Children in clinical risk groups as specified by Public Health England) according to the Green Book, DoH.
* Meets any contraindications to vaccination as outlined in the Green Book, DoH
* 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) and bleeding disorders
* Use of systemic steroids for more than one week e.g. prednisolone \>0.5mg/kg/day in the three months prior to first study intervention
* Chronic administration (≥14 days in total) of immunosuppressant's or other immune modifying drugs in the 3 months prior to first study intervention
* Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation in the three months prior to first study intervention
Temporary exclusion criteria:
* Participants who have experienced fever (≥38.0°C) or coryzal symptoms within the 24 hours prior to first study intervention
* Actively wheezing or increased bronchodilators in the previous 72 hours prior to first study intervention
* Immunisation with inactivated vaccines within the week prior to first study intervention, or live vaccines within the three weeks prior to first study intervention
* Receipt of antipyretics within six hours prior to immunisation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
48 Months
Maximum Age:
72 Months
Study:
NCT04222595
Study Brief:
Protocol Section:
NCT04222595