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 @ 3:15 AM
Ignite Modification Date:
2025-12-25 @ 3:15 AM
NCT ID:
NCT00192205
Eligibility Criteria:
Inclusion Criteria:
* who are aged at least 6 months and less than 72 months of age at the time of enrolment;
* who have experienced two or more practitioner attended RTIs\* in the past 12 months (since birth if less than 12 months old); \* RTIs are defined as upper RTIs including (but not limited to) common cold, acute otitis media and lower RTIs including (but not limited to) bronchiolitis, bronchitis and pneumonia.
* whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained;
* who, along with their parent(s)/legal guardian(s), will be available for duration of the trial;
* whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts \[telephone, clinic or home visit\].
Exclusion Criteria:
* whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
* with Down's syndrome or other known cytogenetic disorders;
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids of a dose equivalent to (i) 2mg/kg/day or greater of Prednisolone or (ii) equivalent to a total of 20 mg/day or greater for children who weigh more than 10kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 27;
* who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
* for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrolment through to the conclusion of the study;
* who have an immunosuppressed or an immunocompromised individual living in the same household;
* who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational) or is anticipated to receive a non-study influenza vaccine after enrollment;
* with a documented history of hypersensitivity to egg or egg protein or any other component of CAIV-T or TIV;
* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrolment or for which use is anticipated during the study;
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results;
Note: Pregnancy in any person who has regular contact with the subject is not a contraindication to the enrolment or ongoing participation of the subject in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
71 Months
Study:
NCT00192205
Study Brief:
Protocol Section:
NCT00192205