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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT02093260
Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Parents have been informed properly regarding the study and signed the informed consent form
* Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial
Exclusion Criteria:
* Subjects concomitantly enrolled or scheduled to be enrolled in another trial
* Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature \>=37oC)
* Known history of allergy to egg and/or chicken protein or any other component of the vaccines
* Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
* Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\>2 weeks)).
* Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives.
* Subjects has been immunized with influenza vaccine within 1 year
* Subjects receives any vaccination within 1 months before and after immunization of Flubio.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
11 Years
Study:
NCT02093260
Study Brief:
Protocol Section:
NCT02093260