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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified February 2010 by British Columbia Centre for Disease Control.
Recruitment status was: Enrolling by invitation

Sponsor:

ClinicalTrials.gov Identifier:

NCT01067404

First Posted: February 11, 2010

Last Update Posted: February 11, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

British Columbia Centre for Disease Control

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:

MedlinePlus related topics: Flu Flu Shot

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

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 ]


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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 Submitted:	February 10, 2010
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

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