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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
British Columbia Centre for Disease Control

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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