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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT00731393
Eligibility Criteria:
Inclusion Criteria:
* Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
* Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.
* All children included in the study must never have been given a prophylactic influenza inoculation.
* Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an understandable language.
Exclusion Criteria:
* Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period until 30 days after administration of the second vaccine dose.
* Acute disease at the beginning of the study
* Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests.
* Known allergic reactions that might have been caused by one or more components of the vaccine.
* Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
6 Years
Study:
NCT00731393
Study Brief:
Protocol Section:
NCT00731393