TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost

Influenza Clinical Trial

— TITRE IIB  

Official title:

TITRE IIB Follow-Up: TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01235000
• Other study ID #: CIHR 200903CVC-203708/99971a
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 4, 2010
• Last updated: November 4, 2010
• Start date: October 2010

Study information

• Verified date: November 2010
• Source: British Columbia Centre for Disease Control
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 29 Months to 51 Months

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• 2010-11 trivalent inactivated influenza vaccine
A single age-appropriate dose of 2010-11 trivalent inactivated influenza vaccine

Locations

Country	Name	City	State
Canada	McGill University Health Centre - Vaccine Study Centre	Montreal	Quebec
Canada	Université Laval - Unité de recherche en santé publique	Québec	Quebec
Canada	BC Centre for Disease Control	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Centre for Disease Control

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The seroprotection rate for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses	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	4-6 weeks following a single dose of 2010-11 trivalent inactivated influenza vaccine (TIV)	No
Secondary	Antibody response to other relevant TIV components	Other indicators of antibody response to each of the relevant TIV components will also be assessed	4-6 weeks following a single dose of 2010-11 TIV	No