Status:
COMPLETED
Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
Lead Sponsor:
British Columbia Centre for Disease Control
Conditions:
Influenza
Eligibility:
All Genders
6-23 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influe...
Eligibility Criteria
Inclusion
- Child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination
- Child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age)
- Child is available and can complete all relevant procedures during the entire study period
- Parent or legal guardian is available and can be reached by phone during the entire study period
- Parent/guardian provides written informed consent
- Parent/guardian is fluent in English
Exclusion
- Child has history of laboratory-confirmed influenza
- Child has history of any prior influenza immunization
- Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg)
- 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 (inhaled or topical steroids allowed)
- Child has a bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopenia, coagulation disorder, anti-coagulant therapy)
- Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period
- Child is scheduled to receive a live vaccine (notably measles, mumps, rubella or varicella vaccines) during the study period
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00710866
Start Date
August 1 2008
End Date
March 1 2009
Last Update
August 4 2011
Active Locations (5)
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1
Coquitlam, British Columbia, Canada, V3C 4J2
2
Vaccine Evaluation Centre
Vancouver, British Columbia, Canada
3
Dalhousie University / IWK Health Centre
Halifax, Nova Scotia, Canada
4
McGill University Health Centre - Vaccine Study Centre
Montreal, Quebec, Canada, H9H4Y6