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

February 10, 2010 updated by: British Columbia Centre for Disease Control
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
0.25mL dose of 2009-10 trivalent inactivated influenza vaccine (TIV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4-6 weeks after receipt of TIV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Centre for Disease Control

Investigators

  • Principal Investigator: Danuta M Skowronski, MD, BC Centre for Disease Control, Vancouver, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Study Registration Dates

First Submitted

February 10, 2010

First Submitted That Met QC Criteria

February 10, 2010

First Posted (Estimate)

February 11, 2010

Study Record Updates

Last Update Posted (Estimate)

February 11, 2010

Last Update Submitted That Met QC Criteria

February 10, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIHR 200903CVC-203708/99971

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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