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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
British Columbia Centre for Disease Control
ClinicalTrials.gov Identifier:
NCT01067404
First received: February 10, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Influenza
Biological: Trivalent inactivated influenza vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B

Resource links provided by NLM:


Further study details as provided by British Columbia Centre for Disease Control:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2010
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Months to 3 Years
Genders Eligible for Study:   Both
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)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067404

Locations
Canada, British Columbia
BC Centre for Disease Control
Vancouver, British Columbia, Canada, V5Z4R4
Canada, Quebec
McGill University Health Centre - Vaccine Study Centre
Montreal, Quebec, Canada
Université Laval - Unité de recherche en santé publique
Québec, Quebec, Canada
Sponsors and Collaborators
British Columbia Centre for Disease Control
Investigators
Principal Investigator: Danuta M Skowronski, MD BC Centre for Disease Control, Vancouver, Canada
  More Information

No publications provided by British Columbia Centre for Disease Control

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Danuta M. Skowronski, BC Centre for Disease Control
ClinicalTrials.gov Identifier: NCT01067404     History of Changes
Other Study ID Numbers: CIHR 200903CVC-203708/99971
Study First Received: February 10, 2010
Last Updated: February 10, 2010
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Centre for Disease Control:
Influenza vaccines
Infant
Dose-Response relationship, immunologic

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014