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TITRE III: Influenza B Immunogenicity Investigation

Primary Purpose

Influenza

Status

Active

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

2018-19 quadrivalent inactivated influenza vaccine

About this trial

This is an interventional other trial for Influenza

Eligibility Criteria

10 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

British Columbia Centre for Disease Control

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

influenza vaccine recipients

Arm Description

Participants of an earlier clinical trial (TITRE I) to receive one dose of the 2018-19 quadrivalent inactivated influenza vaccine

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Seroconversion rate (SCR) for B/Victoria vaccine strains

Seroprotection rate (SPR) for B/Yamagata vaccine strains

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

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

Seroconversion rate (SCR) for B/Yamagata vaccine strains

Seroprotection rate (SPR) for A/H1N1 vaccine strains

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

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

Seroconversion rate (SCR) for A/H1N1 vaccine strains

Seroprotection rate (SPR) for A/H3N2 vaccine strains

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

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

Seroconversion rate (SCR) for A/H3N2 vaccine strains

Full Information

NCT ID

NCT03753347

First Posted

November 13, 2018

Last Updated

August 8, 2023

Sponsor

British Columbia Centre for Disease Control

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03753347

Brief Title

TITRE III: Influenza B Immunogenicity Investigation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

April 12, 2019 (Actual)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

British Columbia Centre for Disease Control

Collaborators

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

4. Oversight

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.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

influenza vaccine recipients

Arm Type

Experimental

Arm Description

Participants of an earlier clinical trial (TITRE I) to receive one dose of the 2018-19 quadrivalent inactivated influenza vaccine

Intervention Type

Biological

Intervention Name(s)

2018-19 quadrivalent inactivated influenza vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

Seroprotection rate (SPR) for B/Victoria vaccine strains

Description

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

Time Frame

Pre-vaccination

Title

Seroprotection rate (SPR) for B/Victoria vaccine strains

Description

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

Time Frame

4-6 weeks after receipt of QIV

Secondary Outcome Measure Information:

Title

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

Time Frame

Pre-vaccination

Title

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

Time Frame

4-6 weeks after receipt of QIV

Title

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

Time Frame

4-6 weeks after receipt of QIV

Title

Seroconversion rate (SCR) for B/Victoria vaccine strains

Time Frame

4-6 weeks after receipt of QIV

Title

Seroprotection rate (SPR) for B/Yamagata vaccine strains

Time Frame

Pre-vaccination

Title

Seroprotection rate (SPR) for B/Yamagata vaccine strains

Time Frame

4-6 weeks after receipt of QIV

Title

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

Time Frame

Pre-vaccination

Title

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

Time Frame

4-6 weeks after receipt of QIV

Title

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

Time Frame

4-6 weeks after receipt of QIV

Title

Seroconversion rate (SCR) for B/Yamagata vaccine strains

Time Frame

4-6 weeks after receipt of QIV

Title

Seroprotection rate (SPR) for A/H1N1 vaccine strains

Time Frame

Pre-vaccination

Title

Seroprotection rate (SPR) for A/H1N1 vaccine strains

Time Frame

4-6 weeks after receipt of QIV

Title

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

Time Frame

Pre-vaccination

Title

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

Time Frame

4-6 weeks after receipt of QIV

Title

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

Time Frame

4-6 weeks after receipt of QIV

Title

Seroconversion rate (SCR) for A/H1N1 vaccine strains

Time Frame

4-6 weeks after receipt of QIV

Title

Seroprotection rate (SPR) for A/H3N2 vaccine strains

Time Frame

Pre-vaccination

Title

Seroprotection rate (SPR) for A/H3N2 vaccine strains

Time Frame

4-6 weeks after receipt of QIV

Title

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

Time Frame

Pre-vaccination

Title

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

Time Frame

4-6 weeks after receipt of QIV

Title

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

Time Frame

4-6 weeks after receipt of QIV

Title

Seroconversion rate (SCR) for A/H3N2 vaccine strains

Time Frame

4-6 weeks after receipt of QIV

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danuta M Skowronski, MD

Organizational Affiliation

BC Centre for Disease Control

Official's Role

Principal Investigator

Facility Information:

Facility Name

British Columbia Centre for Disease Control

City

Vancouver

State/Province

British Columbia (BC)

ZIP/Postal Code

V5Z 4R4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

21857263

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 Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.

Results Reference

result

PubMed Identifier

21768314

Citation

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.

Results Reference

result

Learn more about this trial

TITRE III: Influenza B Immunogenicity Investigation

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