Clinical trial NCT01235000: TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost
Official title: TITRE IIB Follow-Up: TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza
Keywords: Influenza vaccines
Infant
Dose-Response relationship, immunologic
Prime-boost response
Lead sponsor: British Columbia Centre for Disease Control
Sponsor class: OTHER_GOV
First posted: 2010-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 29
Maximum age (years): 51
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of an earlier clinical trial (TITRE I); enrolled in winter 2008/09 as previously unimmunized infants and toddlers (6-23 months of age) who later participated in 2009-10 study (TITRE II) to receive 2009-10 influenza vaccine

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. The yearly influenza vaccine is designed to protect against both kinds of influenza A but only one or the other kind of influenza B. Current recommendations in Canada are that if an eligible child less than nine years of age has received two doses of influenza vaccine before, then that child only requires a single dose of influenza vaccine in subsequent years of immunization. In a previous study conducted in early 2010 we measured the antibody response to influenza B in children who had previously received two doses of a B/Yamagata kind of virus contained in the 2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in the 2009-10 recommended vaccine. The purpose of this follow-up study is to see if the protection (antibodies in the blood) provided against the influenza B/Victoria kind of virus that was in the 2009-10 vaccine can be improved with another (second) dose of the same B/Victoria kind of virus included in the 2010-11 vaccine. Since influenza B is an illness especially of children, understanding how to best protect children against both kinds of influenza B is important.


Eligibility criteria: Inclusion Criteria:

* Child previously participated in the TITRE II study;
* 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;
* And, parent/guardian is fluent in English/French.

Exclusion Criteria:

* Child has already received the 2010-11 seasonal (TIV) influenza vaccine
* Child has received immune globulin or other blood products within the prior six weeks;
* Child has received injected or oral steroids within prior six weeks;
* Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period;
* Or, child has a recently acquired 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: The seroprotection rate for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses
timeFrame: 4-6 weeks following a single dose of 2010-11 trivalent inactivated influenza vaccine (TIV)
Secondary outcomes:
measure: Antibody response to other relevant TIV components
timeFrame: 4-6 weeks following a single dose of 2010-11 TIV
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Centre for Disease Control
state: British Columbia
city: Montreal
country: Canada
facility: McGill University Health Centre - Vaccine Study Centre
state: Quebec
city: Québec
country: Canada
facility: Université Laval - Unité de recherche en santé publique
state: Quebec
Study officials:
affiliation: BC Centre for Disease Control, Vancouver, Canada
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.