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 influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
262
Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France.
Unnamed facility
Coquitlam, British Columbia, Canada
Vaccine Evaluation Centre
Vancouver, British Columbia, Canada
Dalhousie University / IWK Health Centre
Halifax, Nova Scotia, Canada
McGill University Health Centre - Vaccine Study Centre
Montreal, Quebec, Canada
Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)
Seroprotection rate: HI titers =\>40
Time frame: 27-46 days after the second dose
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)
Seroprotection rate: HI titers =\>40
Time frame: 27-46 days after the second dose
Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)
Seroprotection rate: HI titers =\>40
Time frame: 27-46 days after the second dose
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)
Seroprotection rate: HI titers =\>40
Time frame: 27-46 days after the second dose
Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)
Time frame: 27-46 days after the second dose
Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)
Seroprotection rate: HI titers =\>40
Time frame: 27-46 days after the second dose
Adverse Events: Fever After Either Dose - Infants 6-11 Months
Fever defined as temperature \>= 38 C
Time frame: 3 days after immunization
Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-
Fever defined as temperature \>= 38 C
Time frame: 3 days after immunization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Université de Laval - Unité de recherche en santé publique
Québec, Quebec, Canada