Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity

Phase 3

Completed

Interventions: Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)

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 influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
2	Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)	2 doses 0.25mL VAXIGRIP® at months 0, 1
1	Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)	2 doses 0.5mL VAXIGRIP® at months 0, 1

Primary Outcome Measures

Name	Time	Method
Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)	27-46 days after the second dose	Seroprotection rate: HI titers =\>40
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)	27-46 days after the second dose	Seroprotection rate: HI titers =\>40
Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)	27-46 days after the second dose	Seroprotection rate: HI titers =\>40
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)	27-46 days after the second dose	Seroprotection rate: HI titers =\>40
Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)	27-46 days after the second dose
Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)	27-46 days after the second dose	Seroprotection rate: HI titers =\>40
Adverse Events: Fever After Either Dose - Infants 6-11 Months	3 days after immunization	Fever defined as temperature \>= 38 C
Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-	3 days after immunization	Fever defined as temperature \>= 38 C

Secondary Outcome Measures

Name	Time	Method

Locations (4): Dalhousie University / IWK Health Centre
🇨🇦
Halifax, Nova Scotia, Canada
Vaccine Evaluation Centre
🇨🇦
Vancouver, British Columbia, Canada
McGill University Health Centre - Vaccine Study Centre
🇨🇦
Montreal, Quebec, Canada
Université de Laval - Unité de recherche en santé publique
🇨🇦
Québec, Quebec, Canada