TITRE III: Influenza B Immunogenicity Investigation

Influenza Clinical Trial

Official title:

TITRE III: TIV Infant/Toddler Response Evaluation - Influenza B Immunogenicity Investigation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03753347
• Other study ID #: H18-02607
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: British Columbia Centre for Disease Control
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: June 30, 2024
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• 2018-19 quadrivalent inactivated influenza vaccine
A single age-appropriate dose of 2018-19 quadrivalent inactivated influenza vaccine

Locations

Country	Name	City	State
Canada	British Columbia Centre for Disease Control	Vancouver	British Columbia (BC)

Sponsors (4)

Lead Sponsor	Collaborator
British Columbia Centre for Disease Control	Institut National en Santé Publique du Québec, McGill University Health Centre/Research Institute of the McGill University Health Centre, Vaccine Evaluation Center, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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):e27 — View Citation

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 In — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection rate (SPR) for B/Victoria vaccine strains	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	Pre-vaccination
Primary	Seroprotection rate (SPR) for B/Victoria vaccine strains	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	Geometric mean titre (GMT) for B/Victoria vaccine strains		Pre-vaccination
Secondary	Geometric mean titre (GMT) for B/Victoria vaccine strains		4-6 weeks after receipt of QIV
Secondary	Geometric mean titre ratio (GMTR) for B/Victoria vaccine strains		4-6 weeks after receipt of QIV
Secondary	Seroconversion rate (SCR) for B/Victoria vaccine strains		4-6 weeks after receipt of QIV
Secondary	Seroprotection rate (SPR) for B/Yamagata vaccine strains		Pre-vaccination
Secondary	Seroprotection rate (SPR) for B/Yamagata vaccine strains		4-6 weeks after receipt of QIV
Secondary	Geometric mean titre (GMT) for B/Yamagata vaccine strains		Pre-vaccination
Secondary	Geometric mean titre (GMT) for B/Yamagata vaccine strains		4-6 weeks after receipt of QIV
Secondary	Geometric mean titre ratio (GMTR) for B/Yamagata vaccine strains		4-6 weeks after receipt of QIV
Secondary	Seroconversion rate (SCR) for B/Yamagata vaccine strains		4-6 weeks after receipt of QIV
Secondary	Seroprotection rate (SPR) for A/H1N1 vaccine strains		Pre-vaccination
Secondary	Seroprotection rate (SPR) for A/H1N1 vaccine strains		4-6 weeks after receipt of QIV
Secondary	Geometric mean titre (GMT) for A/H1N1 vaccine strains		Pre-vaccination
Secondary	Geometric mean titre (GMT) for A/H1N1 vaccine strains		4-6 weeks after receipt of QIV
Secondary	Geometric mean titre ratio (GMTR) for A/H1N1 vaccine strains		4-6 weeks after receipt of QIV
Secondary	Seroconversion rate (SCR) for A/H1N1 vaccine strains		4-6 weeks after receipt of QIV
Secondary	Seroprotection rate (SPR) for A/H3N2 vaccine strains		Pre-vaccination
Secondary	Seroprotection rate (SPR) for A/H3N2 vaccine strains		4-6 weeks after receipt of QIV
Secondary	Geometric mean titre (GMT) for A/H3N2 vaccine strains		Pre-vaccination
Secondary	Geometric mean titre (GMT) for A/H3N2 vaccine strains		4-6 weeks after receipt of QIV
Secondary	Geometric mean titre ratio (GMTR) for A/H3N2 vaccine strains		4-6 weeks after receipt of QIV
Secondary	Seroconversion rate (SCR) for A/H3N2 vaccine strains		4-6 weeks after receipt of QIV