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Active, Not Recruiting

NCT Number: NCT03753347

TITRE III: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

British Columbia Centre for Disease Control

Vancouver, British Columbia, V5Z 4R4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2018-19 quadrivalent inactivated influenza vaccine

Biological

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Geometric mean titre (GMT) for B/Victoria vaccine strains

    Time frame: Pre-vaccination

  2. Geometric mean titre (GMT) for B/Victoria vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  3. Geometric mean titre ratio (GMTR) for B/Victoria vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  4. Seroconversion rate (SCR) for B/Victoria vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  5. Seroprotection rate (SPR) for B/Yamagata vaccine strains

    Time frame: Pre-vaccination

  6. Seroprotection rate (SPR) for B/Yamagata vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  7. Geometric mean titre (GMT) for B/Yamagata vaccine strains

    Time frame: Pre-vaccination

  8. Geometric mean titre (GMT) for B/Yamagata vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  9. Geometric mean titre ratio (GMTR) for B/Yamagata vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  10. Seroconversion rate (SCR) for B/Yamagata vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  11. Seroprotection rate (SPR) for A/H1N1 vaccine strains

    Time frame: Pre-vaccination

  12. Seroprotection rate (SPR) for A/H1N1 vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  13. Geometric mean titre (GMT) for A/H1N1 vaccine strains

    Time frame: Pre-vaccination

  14. Geometric mean titre (GMT) for A/H1N1 vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  15. Geometric mean titre ratio (GMTR) for A/H1N1 vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  16. Seroconversion rate (SCR) for A/H1N1 vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  17. Seroprotection rate (SPR) for A/H3N2 vaccine strains

    Time frame: Pre-vaccination

  18. Seroprotection rate (SPR) for A/H3N2 vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  19. Geometric mean titre (GMT) for A/H3N2 vaccine strains

    Time frame: Pre-vaccination

  20. Geometric mean titre (GMT) for A/H3N2 vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  21. Geometric mean titre ratio (GMTR) for A/H3N2 vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

  22. Seroconversion rate (SCR) for A/H3N2 vaccine strains

    Time frame: 4-6 weeks after receipt of QIV

Sponsors and collaborators

Lead sponsor

British Columbia Centre for Disease Control

Other Gov

Collaborators

  • Institut National en Santé Publique du Québec
  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Vaccine Evaluation Center, Canada

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2025
First posted
Nov 27, 2018
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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