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Status unknownNCT01067404TITRE IIUpdated Feb 11, 2010

TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B

An observational study in Influenza, sponsored by British Columbia Centre for Disease Control. Status unknown at 3 sites in Canada. Open to participants aged 18 Months to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-11.

Sponsored by British Columbia Centre for Disease Control · Observational

The sponsor has not verified this record recently (last verified Feb 2010), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Months to 3 Years
Sex
All
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Study 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.

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Conditions studied

  • Influenza

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Keywords

  • Influenza vaccines
  • Infant
  • Dose-Response relationship, immunologic
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In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 50 is below the median of 300 across 305 observational studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

British Columbia Centre for Disease Control is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Months to 3 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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)

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)

Groups and cohorts

  • 2008-09 study TIV recipients

    Infants and toddlers who participated in earlier clinical trial (TITRE) to evaluate dosing (0.25mL versus 0.5mL) of trivalent influenza vaccine (TIV)

    Biological: Trivalent inactivated influenza vaccine

Interventions

  • BiologicalTrivalent inactivated influenza vaccine

    0.25mL dose of 2009-10 trivalent inactivated influenza vaccine (TIV)

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 4-6 weeks after receipt of TIV

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Study locations

3 sites
  • BC Centre for Disease Control
    Vancouver, British Columbia V5Z4R4, Canada
  • McGill University Health Centre - Vaccine Study Centre
    Montreal, Quebec, Canada
  • Université Laval - Unité de recherche en santé publique
    Québec, Quebec, Canada
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References and documents

Publications

  • 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. PubMed 21857263 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01067404
Lead sponsor
British Columbia Centre for Disease Control
First posted
Feb 11, 2010
Start date
Feb 2010
Last update
Feb 11, 2010

Study contacts

Danuta M Skowronski, MD
principal investigator · BC Centre for Disease Control, Vancouver, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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