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:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT02212106
Eligibility Criteria:
Inclusion Criteria:
* Males or females aged 5 to less than 9 years at the time of first study vaccination.
* The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
* In good health, as determined by medical history and a targeted physical examination (if warranted).
Exclusion Criteria:
* Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
* Clinical signs of significant active infection or an elevated oral temperature at study entry.
* A clinically significant medical or psychiatric condition.
* A history of seizures or febrile convulsions or Guillain-Barré syndrome.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
* Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
* Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
* Currently receiving treatment with warfarin or other anticoagulants.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
8 Years
Study:
NCT02212106
Study Brief:
Protocol Section:
NCT02212106