Vaccination Program for Flu
(Influential Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
Disqualifiers: Critical care, Hematology-oncology
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
13678How 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.
1691011Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Standardized inpatient influenza vaccination programActive Control1 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 practicesActive Control1 Intervention
Usual care is defined as the inpatient influenza vaccination practices that currently exist at a given site.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ann and Robert Lurie's Children Hospital of ChicagoChicago, IL
Seattle Children's HospitalSeattle, WA
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
Agency for Healthcare Research and Quality (AHRQ)Collaborator
Seattle Children's HospitalCollaborator
References
Effectiveness of the Adjuvanted Influenza Vaccine in Older Adults at High Risk of Influenza Complications. [2021]MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose trivalent inactivated influenza vaccine (HD-IIV3) elicit an enhanced immune response in older adults compared to standard, quadrivalent inactivated influenza vaccines (IIV4). We sought to determine the relative vaccine effectiveness (rVE) of aIIV3 versus IIV4 and HD-IIV3 in preventing influenza-related medical encounters in this retrospective cohort study involving adults ≥65 years with ≥1 health condition during the 2017-2018 and 2018-2019 influenza seasons. Data were obtained from primary and specialty care electronic medical records linked with pharmacy and medical claims. Adjusted odds ratios (OR) were derived from an inverse probability of treatment-weighted sample adjusted for age, sex, race, ethnicity, geographic region, vaccination week, and health status. rVE was determined using the formula (% rVE = 1 - ORadjusted) × 100. Analysis sets included 1,755,420 individuals for the 2017-2018 season and 2,055,012 for the 2018-2019 season. Compared to IIV4, aIIV3 was 7.1% (95% confidence interval 3.3-10.8) and 20.4% (16.2-24.4) more effective at preventing influenza-related medical encounters in the 2017-2018 and 2018-2019 seasons, respectively. Comparable effectiveness was observed with HD-IIV3 across both seasons. Our results support improved effectiveness of aIIV3 vs IIV4 in a vulnerable population of older adults at high risk of influenza and its complications.
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]Clinical evidence supports use of enhanced influenza vaccines in older adults. Few economic outcome studies have compared adjuvanted trivalent inactivated (aIIV3) and standard egg-derived quadrivalent inactivated influenza vaccines (IIV4e).
Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine over Three Consecutive Influenza Seasons in the United States. [2022]Traditional influenza vaccines may be less immunogenic in adults ≥65 years of age due to immunosenescence. Two influenza vaccines-MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose influenza vaccine (HD-IIV3)-were developed to overcome this problem. We summarize estimates of the relative vaccine effectiveness (rVE) of aIIV3 vs. HD-IIV3 and aIIV3 vs. standard, egg-based quadrivalent influenza vaccines (IIV4e) during the 2017-2018, 2018-2019, and 2019-2020 US influenza seasons using the same underlying electronic medical record and linked claims dataset for all three seasons. The primary outcome was influenza-related medical encounters (IRMEs), defined by diagnostic codes specific to influenza (ICD J09*-J11*). rVE was estimated using propensity score methods adjusting for demographics and health status. rVE estimates demonstrated consistent benefit for aIIV3 over IIV4e in the overall and at-risk populations. Relative to HD-IIV3, aIIV3 provided improved benefit in the overall study population and comparable benefit in the at-risk population across each season.
Cost-effectiveness and public health impact of alternative influenza vaccination strategies in high-risk adults. [2018]High-dose trivalent inactivated influenza vaccine (HD-IIV3) or recombinant trivalent influenza vaccine (RIV) may increase influenza vaccine effectiveness (VE) in adults with conditions that place them at high risk for influenza complications. This analysis models the public health impact and cost-effectiveness (CE) of these vaccines for 50-64year-olds.
Efficacy and effectiveness of high-dose versus standard-dose influenza vaccination for older adults: a systematic review and meta-analysis. [2023]Influenza is responsible for a significant disease burden annually, especially in older adults. This study reviews the relative vaccine efficacy or effectiveness (rVE) of high-dose inactivated trivalent influenza vaccine (HD-IIV3) compared to standard-dose influenza vaccines (SD-IIV3) in adults ≥65 against influenza-associated outcomes to inform evidence-based decision-making to shift clinical practice and standard of care in this population.
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]Trivalent adjuvanted inactivated influenza vaccine (aIIV3) and trivalent high-dose inactivated influenza vaccine (HD-IIV3) are US-licensed for adults aged 65 years and older. Data are needed on the comparative safety, reactogenicity, and health-related quality of life (HRQOL) effects of these vaccines.
Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019. [2021]On 12/23/2009 a new high-dose trivalent inactivated influenza vaccine (IIV3-HD) was licensed for adults aged ≥65 years. We assessed the post-licensure safety data for IIV3-HD in the Vaccine Adverse Event Reporting System (VAERS) during 2011-2019.
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]Vaccination is the most effective means of influenza prevention. Efficacy of trivalent vaccines may be enhanced by including both B strain lineages. This phase 3, double-blind study assessed the immunogenicity and safety/tolerability of a quadrivalent inactivated influenza vaccine (IIV4) versus the United States (US)-licensed 2014-2015 trivalent inactivated influenza vaccine (IIV3-Yamagata [IIV3-YAM]; Afluria) and IIV3 containing the alternate Victoria B strain (IIV3-VIC) in adults ≥18years.
Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices--United States, 2013-2014. [2022]This report updates the 2012 recommendations by CDC's Advisory Committee on Immunization Practices (ACIP) regarding the use of influenza vaccines for the prevention and control of seasonal influenza (CDC. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2012;61:613-8). Routine annual influenza vaccination is recommended for all persons aged ≥ 6 months. For the 2013-14 influenza season, it is expected that trivalent live attenuated influenza vaccine (LAIV3) will be replaced by a quadrivalent LAIV formulation (LAIV4). Inactivated influenza vaccines (IIVs) will be available in both trivalent (IIV3) and quadrivalent (IIV4) formulations. Vaccine virus strains included in the 2013-14 U.S. trivalent influenza vaccines will be an A/California/7/2009 (H1N1)-like virus, an H3N2 virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011, and a B/Massachusetts/2/2012-like virus. Quadrivalent vaccines will include an additional influenza B virus strain, a B/Brisbane/60/2008-like virus, intended to ensure that both influenza B virus antigenic lineages (Victoria and Yamagata) are included in the vaccine. This report describes recently approved vaccines, including LAIV4, IIV4, trivalent cell culture-based inactivated influenza vaccine (ccIIV3), and trivalent recombinant influenza vaccine (RIV3). No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one product is otherwise appropriate. This information is intended for vaccination providers, immunization program personnel, and public health personnel. These recommendations and other information are available at CDC's influenza website (http://www.cdc.gov/flu); any updates also will be found at this website. Vaccination and health-care providers should check the CDC influenza website periodically for additional information.
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]Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate.
Economic evaluation of high-dose inactivated influenza vaccine in adults aged ≥65 years: A systematic literature review. [2021]Due to waning immunity, adults aged ≥65 years are at increased risk of seasonal influenza infection and its complications. Adding to this risk, older adults have reduced responses to influenza vaccines. A high-dose trivalent inactivated influenza vaccine (Fluzone High-Dose, Sanofi Pasteur) (IIV3-HD) was developed to improve protection against influenza in adults aged ≥65 years and has been licensed in the US since 2009 and in Canada since 2015. Post-licensure studies have shown that IIV3-HD is more effective than standard-dose trivalent inactivated influenza vaccine (IIV3-SD) at protecting against influenza infection in this population. Here, we performed a systematic review of economic analyses of IIV3-HD in adults aged ≥65 years.