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InfluenzaPhase 4NCT03753347

TITRE III: Influenza B Immunogenicity Investigation

A Phase 4 study testing 2018-19 quadrivalent inactivated influenza vaccine in people with Influenza, run by British Columbia Centre for Disease Control at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 10 to 13 years
Conditions the study is for
Influenza
What is being tested?
2018-19 quadrivalent inactivated influenza vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteCanada
Study dates
1 Dec 2018to 30 Jun 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • British Columbia Centre for Disease Control

    Vancouver, British Columbia, V5Z 4R4

Other trials in Canada

About this study

Official title: 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.

Conditions
Influenza
Being tested
2018-19 quadrivalent inactivated influenza vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2018-19 quadrivalent inactivated influenza vaccineBiological

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

Study groups in NCT03753347
Study groupRoleWhat they receive
influenza vaccine recipientsExperimentalParticipants of an earlier clinical trial (TITRE I) to receive one dose of the 2018-19 quadrivalent inactivated influenza vaccine
Receives: Biological: 2018-19 quadrivalent inactivated influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Pre-vaccination

  2. 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

    Measured: 4-6 weeks after receipt of QIV

Secondary outcomes (22)

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

    Measured: Pre-vaccination

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: Pre-vaccination

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: Pre-vaccination

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: Pre-vaccination

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: Pre-vaccination

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: Pre-vaccination

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: Pre-vaccination

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: 4-6 weeks after receipt of QIV

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

    Measured: 4-6 weeks after receipt of QIV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start1 Dec 2018
  3. Primary completion12 Apr 2019
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03753347
Sponsor's protocol ID
H18-02607
Status last verified
Jan 2025
First submitted
13 Nov 2018
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 21857263

  • 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.

    PubMed 21768314

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 2018-19 quadrivalent inactivated influenza vaccine in people with Influenza, run by British Columbia Centre for Disease Control at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroprotection rate (SPR) for B/Victoria vaccine strains (time frame: Pre-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03753347, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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