Status:
ACTIVE_NOT_RECRUITING
TITRE III: Influenza B Immunogenicity Investigation
Lead Sponsor:
British Columbia Centre for Disease Control
Collaborating Sponsors:
Vaccine Evaluation Center, Canada
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Influenza
Eligibility:
All Genders
10-13 years
Phase:
PHASE4
Brief Summary
Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" \& "A/H3N2") and two kinds of influenza B ("B/Yamagata" \& "B/Victoria") can cause illness. Historically, the yearly influenza vacc...
Eligibility Criteria
Inclusion
- Child previously completed the TITRE I study in British Columbia or Quebec;
- Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
- 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;
- Parent/guardian is fluent in English/French
Exclusion
- Child has already received the 2018-19 seasonal (TIV or QIV) influenza vaccine;
- Child has a bleeding condition that would prevent vaccine injection or blood collection;
- Child has known or suspected immunodeficiency;
- Child has a suspected or known anaphylactic reaction to any of the vaccine components used in this study;
- Child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child;
- Child has received immune globulin or other blood products within the prior six weeks;
- Child has received injected or oral steroids within the prior six weeks defined by more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone \>0.5mL/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed;
- Child has received any live vaccine within 28 days of the study vaccine or is scheduled to receive live vaccine during the study period;
- Child has received any inactivated vaccine within 14 days of the study vaccine;
- Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03753347
Start Date
December 1 2018
End Date
June 30 2025
Last Update
February 7 2025
Active Locations (1)
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1
British Columbia Centre for Disease Control
Vancouver, British Columbia, Canada, V5Z 4R4