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

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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. 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 or disease	Intervention/treatment
Influenza	Biological: Trivalent inactivated influenza vaccine

Study Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	50 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B
Study Start Date :	February 2010

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Months to 3 Years (Child)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Skowronski DM, Hottes TS, De Serres G, Ward BJ, Janjua NZ, Sabaiduc S, Chan T, Petric M. Influenza Β/Victoria antigen induces strong recall of Β/Yamagata but lower Β/Victoria response in children primed with two doses of Β/Yamagata. Pediatr Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.

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
First Posted:	February 11, 2010
Last Update Posted:	February 11, 2010
Last Verified:	February 2010

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; Vaccines; Immunologic Factors; Physiological Effects of Drugs