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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT02583256
Eligibility Criteria:
Inclusion Criteria:
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
* Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
* Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118\_05.
* For naïve subjects in parent trial V118\_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).
Exclusion Criteria:
* Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.
* Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.
* Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3.
Additional eligibility criteria may be discussed by contacting the site.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
7 Years
Study:
NCT02583256
Study Brief:
Protocol Section:
NCT02583256