TITRE III: Influenza B Immunogenicity Investigation

NCT03753347 | Active Not Recruiting Phase 4

• 1 other identifier: H18-02607
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (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

  Pre-vaccination

• 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 Outcomes (22)

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

  Pre-vaccination

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

  4-6 weeks after receipt of QIV

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

  4-6 weeks after receipt of QIV

• Seroconversion rate (SCR) for B/Victoria vaccine strains

  4-6 weeks after receipt of QIV

• Seroprotection rate (SPR) for B/Yamagata vaccine strains

  Pre-vaccination

Study Arms (1)

influenza vaccine recipients

EXPERIMENTAL

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

Biological: 2018-19 quadrivalent inactivated influenza vaccine

Interventions

2018-19 quadrivalent inactivated influenza vaccine BIOLOGICAL

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

influenza vaccine recipients

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Centre for Disease Control: lead
• Vaccine Evaluation Center, Canada: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Institut National en Santé Publique du Québec: collaborator

Study Sites (1)

British Columbia Centre for Disease Control

Vancouver, British Columbia, V5Z 4R4, Canada

Location

Related Publications (2)

• 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.

  PMID: 21857263 BACKGROUND

• 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.

  PMID: 21768314 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Danuta M Skowronski, MD

  BC Centre for Disease Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Epidemiologist, Influenza and Emerging Respiratory Pathogens

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 27, 2018
• Study Start: December 1, 2018
• Primary Completion: April 12, 2019
• Study Completion: June 30, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-01

Locations

CA (1)