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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02663102
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra according to the locally approved PI.
* Signed informed consent as Informed Consent Form (ICF)/Informed Assent Form (IAF) obtained from the subject/subject's parent(s)/Legally acceptable Representative(s) \[LAR(s)\].
Exclusion Criteria:
* Those who are not eligible for vaccination with Fluarix Tetra according to the local PI.
* Hypersensitivity reaction to Fluarix Tetra.
* History of hypersensitivity reaction to Influenza vaccine.
* History of Guillain-Barre syndrome or other nervous system abnormalities to Influenza vaccine within 6 weeks post-vaccination.
* Those who are not eligible for vaccination with Fluarix Tetra according to the medical judgement of physician.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT02663102
Study Brief:
Protocol Section:
NCT02663102