Clinical trial NCT01067404: TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B
Official title: TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza
Keywords: Influenza vaccines
Infant
Dose-Response relationship, immunologic
Lead sponsor: British Columbia Centre for Disease Control
Sponsor class: OTHER_GOV
First posted: 2010-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of earlier clinical trial (TITRE I); enrolled in winter 2008/09 as previously unimmunized infants and toddlers (6-23 months of age)

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. The vaccine is changed from year to year, meaning it may include one kind of B virus one year and the other kind another year. But because influenza is so hard to predict, sometimes the kind of B virus chosen for the vaccine may not match the kind that is causing illness. The National Advisory Committee on Immunization recommends that all infants and toddlers receive influenza vaccine to protect against their high rates of hospitalization. Infants/toddlers receiving influenza vaccine for the first time must get two doses (prime plus boost) to have a good antibody response. If they have ever before received a single dose of influenza vaccine, then they are recommended to receive only one dose each year afterwards. But we don't know how well previous doses of one kind of influenza B set the stage for good antibody response to a single dose of the other kind of influenza B. This study will try to answer that question in a group of infants/toddlers who last year received two doses of one kind of B virus ("Yamagata"), as part of another study. This year, we will give them a single dose of influenza vaccine that now contains the other kind of B virus ("Victoria") and see how much antibody they make to both kinds. About half these children received a higher amount of influenza vaccine in the previous year's study, so we will also compare their antibody levels on that basis. Since influenza B is an illness especially of children, understanding how to best protect infants/toddlers against both kinds of influenza B is important. This study will help us know if we need to design a new vaccine that not only includes both kinds of influenza A, but also both kinds of influenza B.


Eligibility criteria: Inclusion Criteria:

* Child previously participated in the TITRE I study;
* Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
* Child has received the 2009 pandemic H1N1 influenza vaccine;
* 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 2009-10 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: Immunogenicity based on CPMP criteria (seroprotection, defined as reciprocal HI titre equal to/greater than 40; seroconversion rate and factor) for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses
timeFrame: 4-6 weeks after receipt of TIV
Secondary outcomes:
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.