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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03336593
Eligibility Criteria:
Inclusion Criteria for Subjects 9 - 40 Years of Age:
* Healthy
* Properly informed about the study and having signed the informed consent form
* Subject/Parent will commit themselves to comply with the instructions of the investigator and the schedule of the trial.
Inclusion Criteria for Subjects 6 Months - 8 Years of Age:
* 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:
* Subject concomitantly enrolled or scheduled to be enrolled in another trial
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>= 37.5 C )
* Known history of allergy to egg and or chicken protein or any component of the vaccines
* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
* Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks).
* Pregnancy \& Lactation (Adult)
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
* Subject already immunized with influenza vaccine within 1 year.
* Subjects receive any vaccination within 1 month before and after immunization of Quadrivalent Influenza Vaccine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
40 Years
Study:
NCT03336593
Study Brief:
Protocol Section:
NCT03336593