Clinical trial NCT00710866: Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza Vaccines
Infant
Dose-Response Relationship, Immunologic
Lead sponsor: British Columbia Centre for Disease Control
Sponsor class: OTHER_GOV
First posted: 2008-07-08
Enrollment: 262
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)
timeFrame: 27-46 days after the second dose
measure: Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)
timeFrame: 27-46 days after the second dose
measure: Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)
timeFrame: 27-46 days after the second dose
measure: Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)
timeFrame: 27-46 days after the second dose
measure: Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)
timeFrame: 27-46 days after the second dose
measure: Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)
timeFrame: 27-46 days after the second dose
measure: Adverse Events: Fever After Either Dose - Infants 6-11 Months
timeFrame: 3 days after immunization
measure: Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-
timeFrame: 3 days after immunization
Secondary outcomes:
Other outcomes:
Locations:
city: Coquitlam
country: Canada
state: British Columbia
city: Vancouver
country: Canada
facility: Vaccine Evaluation Centre
state: British Columbia
city: Halifax
country: Canada
facility: Dalhousie University / IWK Health Centre
state: Nova Scotia
city: Montreal
country: Canada
facility: McGill University Health Centre - Vaccine Study Centre
state: Quebec
city: Québec
country: Canada
facility: Université de Laval - Unité de recherche en santé publique
state: Quebec
Study officials:
affiliation: BC Centre for Disease Control
name: Danuta M Skowronski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skowronski DM, Hottes TS, De Serres G, Ward BJ, Janjua NZ, Sabaiduc S, Chan T, Petric M. Influenza Beta/Victoria antigen induces strong recall of Beta/Yamagata but lower Beta/Victoria response in children primed with two doses of Beta/Yamagata. Pediatr Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.
citation: Skowronski DM, Hottes TS, Chong M, De Serres G, Scheifele DW, Ward BJ, Halperin SA, Janjua NZ, Chan T, Sabaiduc S, Petric M. Randomized controlled trial of dose response to influenza vaccine in children aged 6 to 23 months. Pediatrics. 2011 Aug;128(2):e276-89. doi: 10.1542/peds.2010-2777. Epub 2011 Jul 18.