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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01067404
Eligibility Criteria:
Inclusion Criteria:
* Child previously participated in the TITRE I study;
* Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
* Child has received the 2009 pandemic H1N1 influenza vaccine;
* Child is available and can complete all relevant procedures during the study period;
* Parent or legal guardian is available and can be reached by phone during the study period;
* Parent/guardian provides written informed consent;
* And, parent/guardian is fluent in English/French.
Exclusion Criteria:
* Child has already received the 2009-10 seasonal (TIV) influenza vaccine;
* Child has received immune globulin or other blood products within the prior six weeks;
* Child has received injected or oral steroids within prior six weeks;
* Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period;
* Or, child has a recently acquired health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
3 Years
Study:
NCT01067404
Study Brief:
Protocol Section:
NCT01067404