- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03753347
TITRE III: Influenza B Immunogenicity Investigation
TITRE III: TIV Infant/Toddler Response Evaluation - Influenza B Immunogenicity Investigation
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. Historically, the yearly influenza vaccine that was recommended in children was designed to protect against both kinds of influenza A but only one kind of influenza B. In a series of trials conducted between 2008-09 and 2010-11 (TITRE I, II, and IIB), the TITRE investigators measured antibody response to influenza B in children who were primed with two doses of trivalent inactivated influenza vaccine (TIV) containing B/Yamagata. Overall, the investigators found that 2 doses of vaccine containing B/Yamagata did not adequately prime children for response to the alternate B/Victoria antigen and that subsequent vaccine doses containing B/Victoria-lineage antigen strongly boosted antibodies to the B/Yamagata antigen that was introduced during first immunization priming, but with lower responses to B/Victoria.
For the first time since 2009-10, the recommended B/Victoria component of the seasonal influenza vaccine has been changed, from B/Brisbane/60/2008 to B/Colorado/60/2007 for the coming 2018-19 season. The investigators thus have a unique opportunity to clarify lineage-specific influenza B responses in a well-characterized cohort of children originally primed to Yamagata. The investigators' main interest is to assess whether TITRE I children primed with two doses of B/Yamagata in 2008-09 have since or are now capable of achieving a sufficient antibody response to B/Victoria following a single dose of 2018-19 QIV, ten years after their initial TIV B/Yamagata priming exposure.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
British Columbia (BC)
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Vancouver, British Columbia (BC), Canada, V5Z 4R4
- British Columbia Centre for Disease Control
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child previously completed the TITRE I study in British Columbia or Quebec;
- 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;
- Parent/guardian is fluent in English/French
Exclusion Criteria:
- Child has already received the 2018-19 seasonal (TIV or QIV) influenza vaccine;
- Child has a bleeding condition that would prevent vaccine injection or blood collection;
- Child has known or suspected immunodeficiency;
- Child has a suspected or known anaphylactic reaction to any of the vaccine components used in this study;
- Child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child;
- Child has received immune globulin or other blood products within the prior six weeks;
- Child has received injected or oral steroids within the prior six weeks defined by more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone >0.5mL/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed;
- Child has received any live vaccine within 28 days of the study vaccine or is scheduled to receive live vaccine during the study period;
- Child has received any inactivated vaccine within 14 days of the study vaccine;
- Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: influenza vaccine recipients
Participants of an earlier clinical trial (TITRE I) to receive one dose of the 2018-19 quadrivalent inactivated influenza vaccine
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A single age-appropriate dose of 2018-19 quadrivalent inactivated influenza vaccine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroprotection rate (SPR) for B/Victoria vaccine strains
Time Frame: Pre-vaccination
|
SPR based on hemagglutination inhibition (HI) assay for current (B/Colorado/06/2017-like) and prior (B/Brisbane/60/2008-like) Victoria lineage vaccine strains
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Pre-vaccination
|
Seroprotection rate (SPR) for B/Victoria vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
SPR based on hemagglutination inhibition (HI) assay for current (B/Colorado/06/2017-like) and prior (B/Brisbane/60/2008-like) Victoria lineage vaccine strains
|
4-6 weeks after receipt of QIV
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geometric mean titre (GMT) for B/Victoria vaccine strains
Time Frame: Pre-vaccination
|
Pre-vaccination
|
Geometric mean titre (GMT) for B/Victoria vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Geometric mean titre ratio (GMTR) for B/Victoria vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
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4-6 weeks after receipt of QIV
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Seroconversion rate (SCR) for B/Victoria vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
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4-6 weeks after receipt of QIV
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Seroprotection rate (SPR) for B/Yamagata vaccine strains
Time Frame: Pre-vaccination
|
Pre-vaccination
|
Seroprotection rate (SPR) for B/Yamagata vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Geometric mean titre (GMT) for B/Yamagata vaccine strains
Time Frame: Pre-vaccination
|
Pre-vaccination
|
Geometric mean titre (GMT) for B/Yamagata vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Geometric mean titre ratio (GMTR) for B/Yamagata vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Seroconversion rate (SCR) for B/Yamagata vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
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4-6 weeks after receipt of QIV
|
Seroprotection rate (SPR) for A/H1N1 vaccine strains
Time Frame: Pre-vaccination
|
Pre-vaccination
|
Seroprotection rate (SPR) for A/H1N1 vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
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4-6 weeks after receipt of QIV
|
Geometric mean titre (GMT) for A/H1N1 vaccine strains
Time Frame: Pre-vaccination
|
Pre-vaccination
|
Geometric mean titre (GMT) for A/H1N1 vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Geometric mean titre ratio (GMTR) for A/H1N1 vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Seroconversion rate (SCR) for A/H1N1 vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Seroprotection rate (SPR) for A/H3N2 vaccine strains
Time Frame: Pre-vaccination
|
Pre-vaccination
|
Seroprotection rate (SPR) for A/H3N2 vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Geometric mean titre (GMT) for A/H3N2 vaccine strains
Time Frame: Pre-vaccination
|
Pre-vaccination
|
Geometric mean titre (GMT) for A/H3N2 vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Geometric mean titre ratio (GMTR) for A/H3N2 vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Seroconversion rate (SCR) for A/H3N2 vaccine strains
Time Frame: 4-6 weeks after receipt of QIV
|
4-6 weeks after receipt of QIV
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Danuta M Skowronski, MD, BC Centre for Disease Control
Publications and helpful links
General Publications
- Skowronski DM, Hottes TS, De Serres G, Ward BJ, Janjua NZ, Sabaiduc S, Chan T, Petric M. Influenza Beta/Victoria antigen induces strong recall of Beta/Yamagata but lower Beta/Victoria response in children primed with two doses of Beta/Yamagata. Pediatr Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.
- Skowronski DM, Hottes TS, Chong M, De Serres G, Scheifele DW, Ward BJ, Halperin SA, Janjua NZ, Chan T, Sabaiduc S, Petric M. Randomized controlled trial of dose response to influenza vaccine in children aged 6 to 23 months. Pediatrics. 2011 Aug;128(2):e276-89. doi: 10.1542/peds.2010-2777. Epub 2011 Jul 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H18-02607
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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