Influenza Vaccine for Flu

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: British Columbia Centre for Disease Control

Must not be taking: Immune suppressants, Steroids

Disqualifiers: Immunodeficiency, Anaphylactic reaction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how well children who received a specific type of flu vaccine (B/Yamagata) years ago respond to a new flu vaccine that includes a different strain (B/Victoria). Researchers seek to determine if these children can now build strong immunity against the B/Victoria strain after a decade. Children who participated in the original study (TITRE I), are healthy, and have not yet received the 2018-19 quadrivalent inactivated influenza vaccine are suitable candidates for this trial. As a Phase 4 trial, this study involves an FDA-approved vaccine and helps to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if your child is taking injected or oral steroids, they must not have taken them within the prior six weeks, except for nasal, topical, or inhaled steroids, which are allowed.

What is the safety track record for the 2018-19 quadrivalent inactivated influenza vaccine?

Research has shown that flu vaccines are generally safe. Vaccine safety monitoring systems have established a strong safety record for these vaccines. For the 2018-19 flu vaccine, reports indicated more mild reactions after vaccination than before. These reactions are typically minor and expected, such as soreness at the injection site or a mild fever.

Moreover, larger studies have not identified any serious safety issues, even for conditions like pregnancy or birth problems, after receiving similar vaccines. Overall, the evidence suggests that the flu vaccine is well-tolerated and safe to use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The 2018-19 quadrivalent inactivated influenza vaccine is unique because it targets four different strains of the flu virus in one shot. Unlike traditional flu vaccines, which often cover fewer strains, this quadrivalent version offers broader protection. Researchers are excited about this vaccine because it aims to improve effectiveness and reduce the chances of getting sick from the flu, especially in years when the circulating strains are tough to predict. This broader coverage can make a significant difference in public health by potentially reducing the overall number of flu cases.

What is the effectiveness track record for the 2018-19 quadrivalent inactivated influenza vaccine?

Research has shown that the quadrivalent inactivated influenza vaccine (QIV), which participants in this trial will receive, effectively prevents flu-related illnesses. This flu shot protects against four virus strains and has reduced hospital visits for the flu more successfully than older vaccines. Studies on children have found that vaccines with the B/Victoria component can improve immune responses, even if earlier shots targeted different strains. Specifically, the 2018-19 QIV could trigger a strong immune response against the B/Victoria strain in children who previously received shots for other strains. Overall, the vaccine is considered a strong option for flu prevention. ^{4 6 7 8 9}

Who Is on the Research Team?

Danuta M Skowronski, MD

Principal Investigator

BC Centre for Disease Control

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one dose of the 2018-19 quadrivalent inactivated influenza vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for seroprotection rate (SPR) for B/Victoria vaccine strains

4-6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 2018-19 quadrivalent inactivated influenza vaccine

Trial Overview 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.

How Is the Trial Designed?

Group I: influenza vaccine recipients Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

British Columbia Centre for Disease Control

Lead Sponsor

Trials

11

Recruited

2,600+

Vaccine Evaluation Center, Canada

Collaborator

Trials

3

Recruited

340+

Institut National en Santé Publique du Québec

Collaborator

Trials

10

Recruited

21,700+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Published Research Related to This Trial

The high-dose inactivated influenza vaccine quadrivalent (HD-IIV4) has been shown to be safe and effective in preventing influenza in adults aged 65 and older, with improved immunogenicity against additional B strains compared to standard vaccines.

Despite some increased adverse reactions like injection-site pain and myalgia, HD-IIV4 is recommended as the vaccine of choice for older adults due to its superior efficacy compared to other influenza vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults. Chahine, EB.[2021]

The inactivated quadrivalent influenza vaccine (IIV4) was found to be safe and well-tolerated in a phase III trial involving 1,648 adults and 329 children/adolescents, with no serious adverse events reported.

IIV4 induced strong antibody responses to all four influenza strains it targets, meeting all immunogenicity criteria set by the European Medicines Agency, and showed comparable efficacy to the trivalent vaccine (IIV3) in both age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. Cadorna-Carlos, JB., Nolan, T., Borja-Tabora, CF., et al.[2015]

The inactivated quadrivalent influenza vaccine (IIV4) demonstrated good immunogenicity, with seroconversion rates of over 60% for all four influenza strains tested, indicating it effectively stimulates the immune response in healthy individuals aged 3 years and older.

IIV4 was found to be non-inferior to the trivalent vaccine (IIV3) for the A strains and superior for the additional B strains, while showing no significant safety concerns, as no serious adverse events were reported and adverse reactions were similar across all groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: A randomized, double-blind, controlled phase III study in healthy population aged ≥3 years. Chu, K., Xu, K., Tang, R., et al.[2022]

The quadrivalent influenza vaccine AdimFlu-S showed strong immunogenicity in a study of 174 healthy children aged 3 to 17, achieving high seroprotection rates above 96.4% for all vaccine strains.

The vaccine was well tolerated with no serious adverse events reported over a 6-month follow-up period, indicating it is a safe option for improving protection against different influenza B lineages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study. Chang, CY., Cho, CY., Lai, CC., et al.[2021]

A study involving 102,911 participants in Australia found that the quadrivalent inactivated influenza vaccine had a low rate of adverse events, with no significant safety concerns identified across different age groups and vaccine brands.

Children aged 6 months to 4 years reported higher rates of adverse events (8.4%) compared to older individuals, but overall, the rates of fever and medical attendance remained low and within expected levels, suggesting the vaccine is safe for the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia. Pillsbury, AJ., Glover, C., Jacoby, P., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9228909/

Review of Analyses Estimating Relative Vaccine Effectiveness ... We summarize the relative vaccine effectiveness (rVE) of IIV4c versus egg-based quadrivalent influenza vaccines (IIV4e) to prevent influenza-related medical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10610589/

Effectiveness of Cell-Based Quadrivalent Seasonal ... For persons aged 4–64 years, QIVc was consistently more effective than QIVe/TIVe over the three influenza seasons.

3. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7432a2.htm

Prevention and Control of Seasonal Influenza with Vaccines This report describes the Advisory Committee on Immunization Practices' updated seasonal flu vaccination recommendations for 2025–26 flu ...

4. academic.oup.com academic.oup.com/ofid/article/11/10/ofae559/7775992

Relative Effectiveness and Immunogenicity of Quadrivalent ... Immunogenicity studies suggest that recombinant influenza vaccine (RIV) may provide better protection against influenza than standard-dose inactivated influenza ...

5. cslseqirus.us cslseqirus.us/news/new-seqirus-data-published-in-vaccines-highlight-effectiveness

New Seqirus Data Published in Vaccines Highlight ... This retrospective cohort analysis indicated QIVc was more effective in reducing hospitalizations/emergency room (ER) visits caused by influenza, respiratory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7336108/

2017/18 and 2018/19 seasonal influenza vaccine safety ... In 2017/18 and 2018/19, higher rates of events were reported following seasonal influenza vaccination than in the pre-vaccination period.

7. cdc.gov cdc.gov/vaccine-safety/vaccines/flu.html

Influenza (Flu) Vaccine Safety Findings from vaccine safety monitoring systems and scientific studies have shown that flu vaccines have an excellent safety profile. Hundreds ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666577824000893

Safety of quadrivalent recombinant influenza vaccine in ... This large study did not identify any pregnancy, birth, or neonatal/infant safety concerns following receipt of a quadrivalent recombinant influenza vaccine ( ...

9. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-Flucelvax.pdf

Package Insert - Flucelvax The safety population included a total of 2402 children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT (N=1597) or a US- licensed ...