Vaccination Program for Flu

(Influential Trial)

Recruiting at 1 trial location

Overseen By Suchitra Rao

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Critical care, Hematology-oncology

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

Compensation: Varies

Number of Visits: Unknown

22000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the influenza vaccination program?

Research shows that the adjuvanted trivalent inactivated influenza vaccine (aIIV3) is more effective than the standard quadrivalent vaccine (IIV4) in preventing flu-related medical visits in older adults, especially those at high risk of complications. The high-dose vaccine (HD-IIV3) also shows similar effectiveness, making these enhanced vaccines beneficial for older populations. ^{1 2 3 4 5}

Is the flu vaccine safe for humans?

Research shows that various types of flu vaccines, including high-dose and adjuvanted versions, have been studied for safety in older adults. These studies generally support the safety of these vaccines, with monitoring systems like VAERS tracking any adverse events. ^{1 3 6 7 8}

How does the flu vaccination program differ from other treatments for flu?

The flu vaccination program includes a quadrivalent vaccine (IIV4) that offers broader protection by covering two influenza A strains and both B lineages, unlike the trivalent vaccines (IIV3) that cover only one B strain. This broader coverage is intended to provide better protection against seasonal flu. ^{1 6 9 10 11}

What is the purpose of this trial?

This study plans to learn more about whether a stakeholder-informed, standardized inpatient vaccination program will increase influenza vaccination rates of hospitalized children across US pediatric health systems. The first part of the study is to form a multidisciplinary team of stakeholders, including parents, providers, nurses, pharmacists, informaticists, data analysts and communication experts across three sites in synthesizing a best practice implementation guide for an inpatient influenza vaccination program, which will then be piloted at these three sites.

Research Team

Suchitra Rao

Principal Investigator

University of Colorado, Children's Hospital Colorado

Eligibility Criteria

The INFLUENTIAL Trial is for hospitalized children at least 6 months old in participating US health systems, excluding those admitted to critical care or hematology-oncology services. It aims to see if a new program can improve flu vaccination rates.

Inclusion Criteria

I am at least 6 months old.

Admitted to an inpatient unit at a participating health system

I am admitted to a critical care or cancer treatment unit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of a standardized inpatient influenza vaccination program across 12 health systems

12 months

Evaluation

Evaluation of the program's impact using an established dissemination and implementation framework

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after the implementation of the vaccination program

4 weeks

Treatment Details

Interventions

• Existing Influenza Vaccination Practices
• Standardized inpatient influenza vaccination program

Trial Overview This trial tests whether a standardized inpatient influenza vaccination program, developed with input from various healthcare stakeholders and parents, can increase the number of hospitalized children getting flu shots.

Participant Groups

Group I: Standardized inpatient influenza vaccination program Active Control 1 Intervention

Intervention A: The basic intervention is the inpatient influenza vaccination program, which will be comprised of the following core components: informatics and data analytic tools, evidenced-based education and communication, a multidisciplinary leadership team, and end-user engagement. Intervention B: The intensified intervention is the multifaceted influenza vaccination strategy (Intervention A) plus a learning collaborative with lead site facilitation during the trial period.

Group II: Existing inpatient influenza vaccination practices Active Control 1 Intervention

Usual care is defined as the inpatient influenza vaccination practices that currently exist at a given site.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Findings from Research

In a study involving over 3.8 million older adults with health conditions during the 2017-2019 influenza seasons, the MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) was found to be significantly more effective than the standard quadrivalent inactivated influenza vaccine (IIV4) in preventing influenza-related medical encounters, with a relative vaccine effectiveness increase of 7.1% in 2017-2018 and 20.4% in 2018-2019.

The high-dose trivalent inactivated influenza vaccine (HD-IIV3) showed comparable effectiveness to aIIV3, indicating that both enhanced vaccines provide better protection for older adults who are at higher risk for influenza complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Adjuvanted Influenza Vaccine in Older Adults at High Risk of Influenza Complications. Boikos, C., Imran, M., Nguyen, VH., et al.[2021]

In a study involving over 2 million older adults during the 2018-19 and 2019-20 influenza seasons, the adjuvanted trivalent inactivated influenza vaccine (aIIV3) was found to be significantly more effective than the standard quadrivalent inactivated vaccine (IIV4e) in preventing both cardiorespiratory and respiratory diseases.

The use of aIIV3 resulted in substantial cost savings from hospitalizations, amounting to $392 million for cardiorespiratory issues and $145 million for respiratory issues in the 2018-19 season, highlighting both clinical efficacy and economic benefits for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical and economic assessment of adjuvanted trivalent versus standard egg-derived quadrivalent influenza vaccines among older adults in the United States during the 2018-19 and 2019-20 influenza seasons. Levin, MJ., Divino, V., Postma, MJ., et al.[2023]

The MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) showed consistent effectiveness over standard egg-based quadrivalent vaccines (IIV4e) in preventing influenza-related medical encounters among adults aged 65 and older during the 2017-2020 influenza seasons.

When compared to the high-dose influenza vaccine (HD-IIV3), aIIV3 provided better overall benefits while showing comparable effectiveness in at-risk populations, indicating its potential as a superior option for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine over Three Consecutive Influenza Seasons in the United States. Boikos, C., McGovern, I., Ortiz, JR., et al.[2022]

High-dose trivalent inactivated influenza vaccine (HD-IIV3) and recombinant trivalent influenza vaccine (RIV) may improve vaccine effectiveness in adults aged 50-64 who are at high risk for influenza complications, suggesting a potential public health benefit.

The analysis indicates that using HD-IIV3 or RIV for high-risk patients could be a cost-effective strategy, with the HD-IIV3 & SD-IIV4 strategy costing $71,500 per quality-adjusted life year (QALY) gained, highlighting the economic viability of these vaccines in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness and public health impact of alternative influenza vaccination strategies in high-risk adults. Raviotta, JM., Smith, KJ., DePasse, J., et al.[2018]

High-dose inactivated trivalent influenza vaccine (HD-IIV3) provides significantly better protection against influenza-like illness and reduces hospital admissions in adults aged 65 and older compared to standard-dose vaccines, with a relative vaccine efficacy (rVE) of 19.5% for ILI and 9.1% for all-cause hospital admissions.

The study, which meta-analyzed data from seven studies involving a total of 992 screened studies, suggests that HD-IIV3 is more effective in preventing severe outcomes related to influenza, including pneumonia and cardiorespiratory events, indicating it should be considered for routine vaccination in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and effectiveness of high-dose versus standard-dose influenza vaccination for older adults: a systematic review and meta-analysis. Lee, JKH., Lam, GKL., Shin, T., et al.[2023]

In a study involving 757 adults aged 65 and older, the safety profile of the trivalent adjuvanted inactivated influenza vaccine (aIIV3) was found to be noninferior to that of the trivalent high-dose inactivated influenza vaccine (HD-IIV3), with similar rates of moderate-to-severe injection-site pain and other reactions.

Both vaccines did not show significant differences in health-related quality of life (HRQOL) changes post-vaccination, indicating that either vaccine is a safe option for preventing influenza in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial. Schmader, KE., Liu, CK., Harrington, T., et al.[2021]

A review of safety data for the high-dose influenza vaccine (IIV3-HD) in adults aged 65 and older from 2011 to 2019 found no new or unexpected safety concerns, with serious adverse events reported in only 5.9% of cases.

Inadvertent administration of IIV3-HD to children and pregnant women occurred, but no serious adverse events were reported, highlighting the need for better training and education for healthcare providers on vaccine recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019. Moro, PL., Woo, EJ., Marquez, P., et al.[2021]

The quadrivalent inactivated influenza vaccine (IIV4) showed a noninferior immune response compared to the trivalent vaccines (IIV3-YAM and IIV3-VIC) for matched strains, and a superior response for unmatched B strains, based on a study involving 3484 adults.

Safety profiles were similar across all vaccine groups, with mild adverse events reported by 52.9% of participants, although serious adverse events were slightly more frequent in the IIV4 group (2.3%) compared to the IIV3 groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study. Treanor, JT., Albano, FR., Sawlwin, DC., et al.[2022]

The CDC recommends annual influenza vaccination for everyone aged 6 months and older, updating the vaccine formulations for the 2013-14 season to include quadrivalent options that cover more virus strains.

New vaccines approved include the quadrivalent live attenuated influenza vaccine (LAIV4) and quadrivalent inactivated influenza vaccine (IIV4), which provide broader protection by including an additional B virus strain, ensuring coverage of both influenza B lineages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices--United States, 2013-2014. [2022]

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 high-dose trivalent inactivated influenza vaccine (IIV3-HD) is more effective than the standard-dose vaccine (IIV3-SD) in protecting adults aged 65 and older from influenza, as shown in a systematic review of seven studies.

IIV3-HD is also cost-effective or cost-saving compared to IIV3-SD, primarily due to a reduction in hospitalizations for cardiorespiratory events, highlighting its economic benefits in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic evaluation of high-dose inactivated influenza vaccine in adults aged ≥65 years: A systematic literature review. Colrat, F., Thommes, E., Largeron, N., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of the Adjuvanted Influenza Vaccine in Older Adults at High Risk of Influenza Complications. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A clinical and economic assessment of adjuvanted trivalent versus standard egg-derived quadrivalent influenza vaccines among older adults in the United States during the 2018-19 and 2019-20 influenza seasons. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine over Three Consecutive Influenza Seasons in the United States. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cost-effectiveness and public health impact of alternative influenza vaccination strategies in high-risk adults. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and effectiveness of high-dose versus standard-dose influenza vaccination for older adults: a systematic review and meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices--United States, 2013-2014. [2022]

10. Netherlands 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. [2015]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Economic evaluation of high-dose inactivated influenza vaccine in adults aged ≥65 years: A systematic literature review. [2021]