TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost (TITRE IIB)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
British Columbia Centre for Disease Control
ClinicalTrials.gov Identifier:
NCT01235000
First received: November 4, 2010
Last updated: NA
Last verified: November 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. Current recommendations in Canada are that if an eligible child less than nine years of age has received two doses of influenza vaccine before, then that child only requires a single dose of influenza vaccine in subsequent years of immunization. In a previous study conducted in early 2010 we measured the antibody response to influenza B in children who had previously received two doses of a B/Yamagata kind of virus contained in the 2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in the 2009-10 recommended vaccine. The purpose of this follow-up study is to see if the protection (antibodies in the blood) provided against the influenza B/Victoria kind of virus that was in the 2009-10 vaccine can be improved with another (second) dose of the same B/Victoria kind of virus included in the 2010-11 vaccine. Since influenza B is an illness especially of children, understanding how to best protect children against both kinds of influenza B is important.


Condition Intervention
Influenza
Biological: 2010-11 trivalent inactivated influenza vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TITRE IIB Follow-Up: TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The seroprotection rate for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses [ Time Frame: 4-6 weeks following a single dose of 2010-11 trivalent inactivated influenza vaccine (TIV) ] [ Designated as safety issue: No ]
    The seroprotection rate based on hemagglutination inhibition (HI) assay for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses following a single age-appropriate dose of 2010-11 TIV containing B/Brisbane/60/2008(Victoria)-like virus in young children originally primed with two doses of 2008-09 TIV containing B/Florida/4/2006(Yamagata) and who had received a single dose of the 2009-10 TIV containing B/Brisbane/60/2008(Victoria) virus


Secondary Outcome Measures:
  • Antibody response to other relevant TIV components [ Time Frame: 4-6 weeks following a single dose of 2010-11 TIV ] [ Designated as safety issue: No ]
    Other indicators of antibody response to each of the relevant TIV components will also be assessed


Estimated Enrollment: 30
Study Start Date: October 2010
Groups/Cohorts Assigned Interventions
2010-11 influenza vaccine recipients
Participants of an earlier clinical trial (TITRE II) to evaluate prime-boost response across B lineages in 2009-10
Biological: 2010-11 trivalent inactivated influenza vaccine
A single age-appropriate dose of 2010-11 trivalent inactivated influenza vaccine

  Eligibility

Ages Eligible for Study:   29 Months to 51 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants of an earlier clinical trial (TITRE I); enrolled in winter 2008/09 as previously unimmunized infants and toddlers (6-23 months of age) who later participated in 2009-10 study (TITRE II) to receive 2009-10 influenza vaccine

Criteria

Inclusion Criteria:

  • Child previously participated in the TITRE II study;
  • Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
  • 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 2010-11 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235000

Locations
Canada, British Columbia
BC Centre for Disease Control
Vancouver, British Columbia, Canada, V5Z 4R4
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: NCT01235000     History of Changes
Other Study ID Numbers: CIHR 200903CVC-203708/99971a
Study First Received: November 4, 2010
Last Updated: November 4, 2010
Health Authority: Canada: Health Canada

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

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 April 22, 2014