Influenza Vaccine for Flu

Recruiting in Palo Alto (17 mi)

Overseen byDanuta M Skowronski, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: British Columbia Centre for Disease Control

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for children in British Columbia or Quebec who participated in the TITRE I study and haven't had their 2018-19 flu shot. They should be generally healthy, able to complete the study, and have a parent/guardian fluent in English/French who can consent.

Inclusion Criteria

Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination

My child can attend and complete all study procedures.

Parent or legal guardian is available and can be reached by phone during the study period

+3 more

Exclusion Criteria

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

My child hasn't had a live vaccine in the last 28 days and won't get one during the study.

The child has already gotten the flu shot for the 2018-19 flu season.

+7 more

Participant Groups

The trial tests if kids primed with B/Yamagata flu strain via vaccine years ago now respond well to B/Victoria strain in the updated quadrivalent influenza vaccine for the 2018-19 season.

1Treatment groups

Experimental Treatment

Group I: influenza vaccine recipientsExperimental Treatment1 Intervention

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