xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05996549</url>
    </required_header>
    <id_info>
      <org_study_id>PR-23014</org_study_id>
      <nct_id>NCT05996549</nct_id>
    </id_info>
    <brief_title>Cost-effectiveness of the Influenza Vaccination</brief_title>
    <official_title>Acceptability, Cost-Effectiveness, and Capacity of a Facility-Based Seasonal Influenza Vaccination: A Study in Selected Hospitals of Bangladesh</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centers for Disease Control and Prevention</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>Institute of Epidemiology, Disease Control and Research</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Rajshahi Medical College Hospital, Rajshahi , Bangladesh</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Khulna Medical College Hospital, Khulna, Bangladesh</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jalalabad Ragib-Rabeya Medical College &amp; Hospital, Sylhet, Bangladesh</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: In Bangladesh, seasonal influenza imposes considerable health and economic&#xD;
        burden, particularly for those at high risk of severe disease. To prevent influenza and&#xD;
        lessen the economic burden, despite the World Health Organization's (WHO) recommendation of&#xD;
        seasonal influenza vaccination prioritizing high-risk groups, many low-income countries,&#xD;
        including Bangladesh, lack a national policy/programme and relevant statistics on seasonal&#xD;
        influenza vaccination.&#xD;
  &#xD;
        Objectives:&#xD;
  &#xD;
          1. To determine influenza vaccine acceptability, health beliefs, barriers, and intention of&#xD;
             receiving influenza vaccine among targeted high-risk populations&#xD;
  &#xD;
          2. To determine the cost-effectiveness of a seasonal influenza vaccination targeting&#xD;
             high-risk populations during visits to health facilities for routine care&#xD;
  &#xD;
          3. To investigate the required capacity for a potential seasonal influenza vaccination&#xD;
             programme targeting high-risk populations during their visits to health facilities for&#xD;
             routine care&#xD;
  &#xD;
        Methods: The study will be conducted in three hospitals' inpatient and outpatient departments&#xD;
        with ongoing hospital-based influenza surveillance (HBIS). To meet objective 1, the&#xD;
        investigators will collect quantitative data on participants' acceptability, health beliefs,&#xD;
        barriers, and vaccination intentions using the health belief model (HBM) from patients&#xD;
        meeting criteria for high-risk populations attending two public tertiary-level hospitals. To&#xD;
        meet objective 2, in one of the two hospitals, the investigators will run an influenza&#xD;
        vaccination campaign before the influenza season (the vaccines will be in the southern&#xD;
        hemisphere), where the vaccine will be offered free of cost to high-risk patients, and in the&#xD;
        second hospital, vaccination will not be offered. Both the vaccinated and unvaccinated&#xD;
        participants will then be followed-up for one year period once a month to record any&#xD;
        influenza-like illness, hospitalization, and death. Additional data for objective two on&#xD;
        direct and indirect costs associated with influenza illness will be collected from patients&#xD;
        with influenza-like illness (ILI) and severe acute respiratory infections (SARI) at one&#xD;
        public and one private hospital. To meet objective 3, the investigators will estimate the&#xD;
        required number of influenza vaccines, safe injections, and total storage volume utilizing&#xD;
        secondary data. The investigators will use a deterministic Markov decision-analytic model to&#xD;
        estimate the cost-effectiveness of facility-based vaccination in Bangladesh.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Globally, seasonal influenza is a leading cause of morbidity and mortality with&#xD;
        significant health and economic consequences. According to the World Health Organization&#xD;
        (WHO), influenza affects around one billion people each year, with 3 to 5 million suffering&#xD;
        from severe illness, leading to 290,000 to 650,000 deaths each year . The burden of influenza&#xD;
        illness is significantly higher in low- and middle-income countries (LMICs) than in&#xD;
        high-income countries (HIC) . Pregnant women, children under five years, and adults with&#xD;
        co-morbid conditions in LMICs are more likely to get severe influenza illness. In a&#xD;
        systematic review and meta-analysis of 27 studies found that elderly people were at higher&#xD;
        risk of death and hospital admission during flu season. That study also found that pregnant&#xD;
        women and children were at higher risk of developing pneumonia and requiring hospital&#xD;
        admission; the adults with co-morbidity conditions were at risk of hospitalization and&#xD;
        intensive care admission during flu seasons.&#xD;
  &#xD;
        In order to prevent influenza infection and lessen the severity of the illness, in 2012, the&#xD;
        WHO advised an annual influenza vaccine dosage for persons at high risk of acquiring a severe&#xD;
        influenza illness. Despite the WHO recommendation of seasonal influenza vaccination&#xD;
        prioritizing high-risk groups, 76% of the low-income countries, including Bangladesh, lack a&#xD;
        national policy/programme on seasonal influenza targeting high-risk groups. Also, the lack of&#xD;
        context-specific knowledge on the economic burden of influenza vaccines on high-risk groups,&#xD;
        lack of medical, socio-behavioral patterns, and socio-economic consequences of influenza have&#xD;
        been identified as challenges for promoting influenza vaccinations in LMICs.&#xD;
  &#xD;
        In Bangladesh, around 25 million people of all ages sought outpatient treatment for&#xD;
        influenza, where the yearly direct cost of influenza-associated outpatient visits was US$ 108&#xD;
        million. Moreover, approximately 30,592 laboratory-confirmed influenza patients of all ages&#xD;
        were hospitalized each year, with an estimated annual influenza-associated hospitalization&#xD;
        cost of US$ 1.4 million. Influenza vaccines are the most reliable method for preventing&#xD;
        influenza infection. But unfortunately, Bangladesh does not have a national influenza&#xD;
        vaccination program among the WHO-recommended high-risk population. The Ministry of Health&#xD;
        and Family Welfare (MoH&amp;FW), Government of the People's Republic of Bangladesh, only offers&#xD;
        influenza vaccination to all Hajj pilgrims free of cost as part of the mandatory requirement&#xD;
        for all Hajj pilgrims by the Saudi Government. However, there is a lack of information to&#xD;
        drive the MoH&amp;FW policy on influenza vaccinations in high-risk populations.&#xD;
  &#xD;
        For reducing the influenza disease burden, particularly among high-risk populations,&#xD;
        influenza vaccination has been proven to be the most effective and cost-effective approach.&#xD;
        Immune responses elicited by influenza vaccines are generally strain-specific. Antibody&#xD;
        against one influenza virus type or subtype generally confers limited or no protection&#xD;
        against another type or subtype, nor does it typically confer protection against antigenic&#xD;
        variants of the same virus that arise by antigenic drift. However, among adults, vaccination&#xD;
        can cause a &quot;back boost&quot; of antibody titers against influenza A viruses that have been&#xD;
        encountered previously either by vaccination or natural infection. Due to antigenic drift and&#xD;
        shift, influenza vaccines are taken annually with an efficacy between 40-60% varies widely by&#xD;
        setting and by influenza seasons. In addition, a systematic review of 118 studies on the&#xD;
        cost-effectiveness of influenza vaccination revealed that 22 of the 118 studies showed&#xD;
        influenza vaccination to be cost-saving. The study reported cost-effectiveness ratios of&#xD;
        $10,000/outcome in 13 studies, $10,000 to $50,000 in 13 studies, and ≥$50,000 in 3 studies.&#xD;
        Despite the fact that influenza vaccination was cost-effective, the cost-effectiveness&#xD;
        parameters may not be applicable for all countries' contexts because of the differences in&#xD;
        influenza disease profile, influenza vaccination unit costs, and health system delivery&#xD;
        mechanisms. Hence, country-specific estimates are essential for the optimal allocation of&#xD;
        scarce resources.&#xD;
  &#xD;
        The investigators extensively searched influenza vaccination cost-effectiveness studies&#xD;
        targeting high-risk populations in Bangladesh. But to date, there is scarce evidence in&#xD;
        Bangladesh to inform policymakers about the acceptability, cost-effectiveness, and required&#xD;
        capacity of influenza vaccination among the WHO-defined high-risk group population.&#xD;
        Therefore, the investigators propose to generate preliminary data on high-risk groups' health&#xD;
        beliefs, barriers, and intent to receive the influenza vaccine. The investigators will also&#xD;
        generate preliminary data on the acceptability, cost-effectiveness, and required capacity for&#xD;
        a facility-based influenza vaccination program to support policy decisions on influenza&#xD;
        vaccination in Bangladesh among the high-risk population.&#xD;
  &#xD;
        Research Design and Methods:&#xD;
  &#xD;
        Study design:&#xD;
  &#xD;
        The investigators have been conducting our study leveraging hospital-based influenza&#xD;
        surveillance (HBIS) ongoing in nine tertiary-level hospitals across Bangladesh. The study&#xD;
        design is quasi-experimental.&#xD;
  &#xD;
        Study sites:&#xD;
  &#xD;
        The investigators have chosen study hospitals considering several factors. Firstly, the&#xD;
        investigators will conduct this study leveraging hospital-based influenza surveillance. The&#xD;
        investigators have chosen Rajshahi medical college hospital and Khulna medical college&#xD;
        hospital for study activities related to objectives 1 &amp; 2. To meet objectives 1 &amp; 2, as&#xD;
        hospital-based influenza surveillance identifies SARI, ILI, or influenza-positive patients,&#xD;
        it will be helpful to enroll SARI and ILI patients, including those with laboratory-confirmed&#xD;
        influenza, to collect data on the costs of influenza illness. This approach will save funds&#xD;
        for influenza testing not allocated in the current study budget. Secondly, to assess the&#xD;
        outcome of influenza vaccination, the investigators plan to enroll patients from public&#xD;
        tertiary-level hospitals (one treatment/vaccinated and the other control hospital ) to&#xD;
        minimize baseline differences between the treatment/vaccinated and control arm. Thirdly, the&#xD;
        investigators have chosen Ragib-Rabeya Medical College &amp; Hospital to track public and private&#xD;
        healthcare facility cost differences while estimating the costs of influenza illness.&#xD;
  &#xD;
        Study sites for Objective 1:&#xD;
  &#xD;
        The investigators have conducted an HBM survey in two conveniently selected hospitals:&#xD;
  &#xD;
          1. Rajshahi Medical College Hospital, Rajshahi&#xD;
  &#xD;
          2. Khulna Medical College Hospital, Khulna&#xD;
  &#xD;
        Study sites for Objective 2:&#xD;
  &#xD;
        For objective two, the investigators are collecting data on the health outcome of vaccination&#xD;
        and the cost associated with influenza illness. Data on health outcomes have been collected&#xD;
        from two public tertiary-level hospitals (same sites for objective 1). The cost associated&#xD;
        with influenza illness data has been collected from one public and one private hospital.&#xD;
  &#xD;
        Health outcomes of vaccination:&#xD;
  &#xD;
          1. Rajshahi Medical College Hospital, Rajshahi&#xD;
  &#xD;
          2. Khulna Medical College Hospital, Khulna&#xD;
  &#xD;
        Cost associated with influenza illness:&#xD;
  &#xD;
          1. Rajshahi Medical College Hospital, Rajshahi&#xD;
  &#xD;
          2. Jalalabad Ragib-Rabeya Medical College &amp; Hospital, Sylhet&#xD;
  &#xD;
        Study sites for objectives 3:&#xD;
  &#xD;
        The investigators will utilize secondary data to estimate the required capacity for seasonal&#xD;
        influenza vaccination at three hospital catchment areas.&#xD;
  &#xD;
        Study population :&#xD;
  &#xD;
        Study participants are the WHO-defined four different high-risk groups: children six months&#xD;
        to 8 years, pregnant women, elderly ≥60 years, and adults with chronic diseases.&#xD;
  &#xD;
        Data collection to assess health beliefs, barriers, and intention to receive an influenza&#xD;
        vaccine (objective 1):&#xD;
  &#xD;
        The investigators have collected data on acceptability, health beliefs, obstacles, and&#xD;
        current intentions to receive the vaccine from enrolled participants. The investigators have&#xD;
        captured these data using the health belief model (HBM). The questionnaire has been developed&#xD;
        using an existing literature review. The investigators have included items to assess five&#xD;
        theoretical constructs of HBM based on reviewing relevant literature, including high-risk&#xD;
        individual's perceived susceptibility to disease, perceived severity of influenza, perceived&#xD;
        benefits of the vaccine, perceived barriers to the vaccine, cues to action, and&#xD;
        self-efficacy. The investigators have conducted face-to-face interviews for the data&#xD;
        collection.&#xD;
  &#xD;
        Data collection to determine the cost-effectiveness of seasonal influenza vaccination&#xD;
        (objective 2):&#xD;
  &#xD;
        Health outcomes of vaccination:&#xD;
  &#xD;
        Vaccination campaign:&#xD;
  &#xD;
        To record health outcomes after influenza vaccination (objective 2), in one of the two study&#xD;
        hospitals, the investigators have been running an influenza vaccination campaign before the&#xD;
        influenza season, where the vaccine has been offering free of cost to high-risk patients.&#xD;
        Inpatients and outpatients of all departments are informed about the ongoing immunization&#xD;
        campaign. Eligible patients have been offered to take the vaccine during the vaccination&#xD;
        campaign. Benefits, significance, adverse effects, and how to manage them have been explained&#xD;
        to the patients.&#xD;
  &#xD;
        In the second hospital, the investigators are enrolling participants meeting the high-risk&#xD;
        group individual criteria. However, no vaccination campaign will be conducted. The&#xD;
        investigators have named this group as an unvaccinated cohort (Control Arm).&#xD;
  &#xD;
        Follow-up of vaccinated and unvaccinated participants:&#xD;
  &#xD;
        The investigators will follow up with vaccinated and unvaccinated study participants&#xD;
        bi-weekly through mobile phones for the entire influenza season. During the follow-up, data&#xD;
        will be recorded on health outcomes, including respiratory symptoms, influenza-like illness,&#xD;
        hospitalization, and death.&#xD;
  &#xD;
        Cost associated with influenza illness:&#xD;
  &#xD;
        For collecting data on costs associated with influenza illness, the investigators will enroll&#xD;
        high-risk individuals visiting study hospitals who will meet the SARI and ILI case&#xD;
        definitions:&#xD;
  &#xD;
        Severe acute respiratory illness (SARI): For patients of all ages, a history of or measured&#xD;
        temperature ≥ 38.0°C and cough began during the last ten days and necessitated&#xD;
        hospitalization.&#xD;
  &#xD;
        Influenza-like illness (ILI): Measured fever above ≥ 38.0°C with cough having an onset within&#xD;
        the last ten days. The investigators will collect data on the enrolled participants' direct&#xD;
        and indirect medical costs associated with influenza illness episodes. Cost breakdowns for&#xD;
        influenza illness episodes are provided below.&#xD;
  &#xD;
        Direct medical and non-medical costs for influenza illness episodes:&#xD;
  &#xD;
        Direct costs will consist of health care provider fees, hospital registration fees, bed&#xD;
        rental, prescriptions, laboratory testing, transportation, and mobile phone calls. The&#xD;
        investigators will also record informal payments made during hospital visits. Costs for all&#xD;
        medications, laboratory tests, registration, and room rental will also be included. The&#xD;
        investigators will also collect payment if patients visit a pharmacy or other clinics prior&#xD;
        to hospitalization. The non-medical expenses for patients or caregivers include food,&#xD;
        lodging, and transportation. The investigators will collect data directly from patients and&#xD;
        their families. Members of the participant's family or the participants themselves will be&#xD;
        able to determine which drugs and tests they received for free (hospital subsidized cost) and&#xD;
        which they paid for out of pocket (out-of-pocket).&#xD;
  &#xD;
        Productivity loss or indirect cost:&#xD;
  &#xD;
        The investigators will also collect data on participants' or caregivers', or family members'&#xD;
        lost productivity and indirect costs incurred during illness. The investigators will record&#xD;
        the number of workdays missed by participants' family members, participants themselves and&#xD;
        caregivers due to sickness or family caregiving. The investigators will exclude weekends and&#xD;
        national holidays from our calculation. Every day missed due to illness or while caring for&#xD;
        sick family members will be considered a lost workday for hourly-wage workers and housewives.&#xD;
        The investigators will not consider the days missed due to decreased activity (such as a&#xD;
        half-day of work), school absences, or influenza-related fatalities.&#xD;
  &#xD;
        Costs of durable equipment and other fixed costs:&#xD;
  &#xD;
        The investigators are collecting the primary data on the costs of the supplies and materials&#xD;
        consumed (not purchased and stored) at the hospitals involved in diagnosing and treating&#xD;
        influenza illness by department, ward, and service, for example, per unit cost and required&#xD;
        units for blood drawn, x-ray, C-reactive protein, complete blood count, blood culture test,&#xD;
        widal test etc. The investigators are also collecting data related to health facility&#xD;
        operating hours ( working hours by ward and department), the ticket price of different&#xD;
        departments' inpatients or outpatients units, and bed rent.&#xD;
  &#xD;
        Collating secondary data for objective 2:&#xD;
  &#xD;
        Disability-adjusted life year (DALY):&#xD;
  &#xD;
        The investigators will collect secondary data on disability-adjusted life years (DALY) from&#xD;
        the WHO global health estimation. The investigators will utilize age, and symptoms-specific&#xD;
        DALY estimates to determine the DALY associated with influenza-related health outcomes.&#xD;
        Though QALY is widely used for hospital patients, due to the unavailability of publicly&#xD;
        available QALY data related to influenza or influenza-like illnesses for LMICs, the&#xD;
        investigators have decided to use the WHO-estimated publicly available DALY estimates for the&#xD;
        study.&#xD;
  &#xD;
        Data sources for estimating influenza-associated disease burden:&#xD;
  &#xD;
        To estimate the key parameters of influenza-associated disease burden, such as the number of&#xD;
        outpatients visits, hospitalization, and deaths, the investigators will collect data from the&#xD;
        following secondary sources. Assumptions and data sources by each target group are indicated&#xD;
        below.&#xD;
  &#xD;
        Target Study Group 1 (Children 6 months to 8 years) :&#xD;
  &#xD;
        Assumption and data sources: Two doses will be delivered, each four weeks apart. Data on the&#xD;
        total number of &lt;5 years children will be adopted from the Statistical Yearbook of Bangladesh&#xD;
        2020. Monthly the number of children &lt;8 years visited hospitals will be collected from&#xD;
        respected hospitals or respective District Civil Surgeon Office.&#xD;
  &#xD;
        Target Study Group 2 (Pregnant women) :&#xD;
  &#xD;
        Assumption and data sources: One dose to all pregnant women (any trimesters). The crude birth&#xD;
        rate is assumed to be 21.9% (BDHS 2017-18). Influenza vaccines were distributed evenly across&#xD;
        the childbearing years 15 through 49. Data on the total number of women of childbearing age&#xD;
        (15-49 years) will be collected from the Statistical Yearbook of Bangladesh 2020. Monthly&#xD;
        pregnant women who visited hospitals will be collected from respective hospitals or&#xD;
        respective District Civil Surgeon Office.&#xD;
  &#xD;
        Target Study Group 3 (Elderly ≥60 years) :&#xD;
  &#xD;
        Assumption and data sources: One dose for all persons aged 60 years and older. Population&#xD;
        data from the Statistical Yearbook of Bangladesh 2020. Monthly the total number of ≥60 years&#xD;
        aged patients visited hospitals will be collected from respected hospitals or respective&#xD;
        District Civil Surgeon Office.&#xD;
  &#xD;
        Target Study Group 4 (Adults with chronic diseases):&#xD;
  &#xD;
        Assumption and data sources: One dose for all persons with chronic disease. The investigators&#xD;
        will use the prevalence of having any chronic illness from the Bangladesh Household Income&#xD;
        and Expenditure Survey (HIES) 2010. Then, the total number of persons with any chronic&#xD;
        illness will be estimated using data from the Statistical Yearbook of Bangladesh 2020.&#xD;
        Monthly patients with chronic diseases visited hospitals will be collected from respected&#xD;
        hospitals or respective District Civil Surgeon Office.&#xD;
  &#xD;
        Vaccine coverage:&#xD;
  &#xD;
        The investigators will use secondary data for the input parameters relating to seasonal&#xD;
        influenza vaccination coverage in Bangladesh. The investigators will extract information on&#xD;
        hospitals' catchment areas' population size from the Statistical Yearbook of Bangladesh 2020.&#xD;
  &#xD;
        Vaccine adverse event costs:&#xD;
  &#xD;
        Vaccine adverse event costs will be estimated for each targeted risk group. Using primary and&#xD;
        secondary data, the investigators will estimate the costs of influenza vaccination adverse&#xD;
        events. The investigators will use secondary data to estimate influenza vaccination rates and&#xD;
        adverse events, whereas primary data will be used to determine the cost.&#xD;
  &#xD;
        Data collection to estimate the required capacity of a hospital-based influenza vaccination&#xD;
        programme (objective 3):&#xD;
  &#xD;
        The investigators will collect secondary data to calculate the requirements capacity at each&#xD;
        hospital. Secondary data will be collected about the population size of the targeted risk&#xD;
        group in the hospital's catchment area, the number of doses required for vaccinating each&#xD;
        high-risk individual, the number of doses per vial, packed volume, doses syringes, and safety&#xD;
        box.&#xD;
  &#xD;
        Sample Size Calculation:&#xD;
  &#xD;
        The sample size for vaccine acceptability: Primary outcome of this study for vaccine&#xD;
        acceptability is the intention to receive the influenza vaccine. According to high-risk&#xD;
        group-specific health belief model studies from neighboring countries, 91% of elderly people,&#xD;
        88% of adults with chronic illness, 76.3% of pregnant women, and 62.4% of parents with&#xD;
        six-month-to-three-year-olds intended to get the influenza vaccine. The investigators expect&#xD;
        a similar positive intention to receive the influenza vaccine, ranging from 62% to 91% for&#xD;
        our target study population. The investigators utilize a 5% significance level, 80% power,&#xD;
        design effect of 1.2, and 10% non-response to estimate the sample size. The estimated sample&#xD;
        size by the high-risk group for vaccine acceptability (objective 1) is given below.&#xD;
  &#xD;
        The sample size for children six months to 8 years = 659 The sample size for pregnant women =&#xD;
        495 The sample size for Elderly ≥60 years = 330 The sample size for adults with chronic&#xD;
        diseases = 425&#xD;
  &#xD;
        The sample size for vaccine effectiveness: Next outcome for health outcome for vaccination is&#xD;
        vaccine efficacy against influenza-like illness among high-risk group populations. Studies&#xD;
        from neighboring countries found that ILI symptoms were 15.30% of children, 31.23% of adults&#xD;
        with chronic illness, 10.97% of pregnant women, and 20% of the elderly. A systematic review&#xD;
        of seasonal influenza vaccine policy, use, and efficacy also revealed that pooled vaccine&#xD;
        efficacy for high-risk groups in the tropics and subtropics ranged from 48% to 88%. The&#xD;
        investigators expect a similar vaccine efficacy between 50%-81% for our study's targeted&#xD;
        high-risk group population. The investigators also assume a 5% significance level, 80% power,&#xD;
        design effect of 1.2, and 10% non-response to estimate the sample size. The high-risk group's&#xD;
        estimated sample size for vaccine effectiveness is given below.&#xD;
  &#xD;
        The sample size for children six months to 8 years = 465 The sample size for pregnant women =&#xD;
        756 The sample size for Elderly ≥60 years = 736 The sample size for adults with chronic&#xD;
        diseases = 610&#xD;
  &#xD;
        The sample size for the cost-components survey: Another outcome for costs-components is the&#xD;
        total influenza-associated illness costs among high-risk group populations. A study in&#xD;
        Bangladesh on the economic evaluation of influenza-associated disease estimated that the&#xD;
        total direct cost of influenza-associated illness was 7,614 TK for children under five years,&#xD;
        followed by 20,808Tk for pregnant women, 13,761 TK for elderly and 8,222 TK for adults with&#xD;
        chronic diseases. The investigators expect a similar total direct cost of&#xD;
        influenza-associated illness of 7,614Tk-20,808Tk for our study's targeted high-risk group&#xD;
        population. Other than that, the investigators utilize a 5% significance level, 80% power,&#xD;
        design effect of 1.2, and 10% non-response to estimate the sample size. The high-risk group's&#xD;
        estimated sample size for the cost-components survey is given below.&#xD;
  &#xD;
        The sample size for children six months to 8 years = 60 The sample size for pregnant women =&#xD;
        39 The sample size for the Elderly ≥60 years = 56 The sample size for adults with chronic&#xD;
        diseases = 31&#xD;
  &#xD;
        Data Analysis:&#xD;
  &#xD;
        The investigators will summarize all the data by descriptive statistics tools, including&#xD;
        frequency, percentage, mean, median, standard deviation (SD), and interquartile range (25th&#xD;
        percentile - 75th percentile).&#xD;
  &#xD;
        Objective specific data analysis plan is as follows:&#xD;
  &#xD;
        Data analysis on the propensity to vaccine using results from the HBM survey (Objective 1):&#xD;
  &#xD;
        In each of the five HBM constructs, the investigators will use factor analysis using the&#xD;
        principal axis factor technique and varimax rotation to find latent variables and minimize&#xD;
        the number of independent variables. The Kaiser-Meyer-Olkin test will be used to determine&#xD;
        sample adequacy. The investigators will also use Cronbach's alpha to test the internal&#xD;
        consistency of survey items.&#xD;
  &#xD;
        Data analysis for cost-effectiveness analysis (Objective 2):&#xD;
  &#xD;
        Vaccine efficacy estimation:&#xD;
  &#xD;
        The investigators will utilize Poisson regression to obtain rate ratios (RRs) for vaccinated&#xD;
        and unvaccinated individuals against influenza. In the final model, the investigators will&#xD;
        include all the variables that will be found to have a confounding effect or found to be&#xD;
        significant at a 5% level of significance. The investigators will calculate vaccine&#xD;
        effectiveness with 95% CI for each risk group ( (1 - RR) * 100) ).&#xD;
  &#xD;
        Cost-effectiveness estimation:&#xD;
  &#xD;
        To estimate the pilot influenza vaccination cost-effectiveness targeted for the high-risk&#xD;
        group, the investigators will use the built-in formulas of the CETSIV tool. Besides, the&#xD;
        investigators will recheck the outputs by developing a deterministic Markov decision-analytic&#xD;
        model to simulate outcomes under alternative assumptions of input parameters. The&#xD;
        investigators will conduct a probabilistic sensitivity analysis (PSA) to see how parameter&#xD;
        estimation precision uncertainty affects the model's outcome. If ICER is below less than&#xD;
        three times the gross domestic product (GDP) per capita, the investigators will consider the&#xD;
        vaccination as cost-effective, as per the WHO standard.&#xD;
  &#xD;
        Vaccination cost estimation: The financial and economic costs of the vaccination programme&#xD;
        will be collected using the WHO seasonal influenza immunization costing tool (SIICT). The WHO&#xD;
        seasonal influenza immunization costing tool (SIICT) was updated in 2020 and was newly named&#xD;
        The WHO Flutool Plus. The investigators will use the newly developed WHO Flutool Plus and&#xD;
        customize all the components for the facility-based vaccination. However, the investigators&#xD;
        assume a discount rate of 5%. Bangladesh Bank Dollars exchange rate of 105 to 110 TK will be&#xD;
        used to represent the findings at all estimates. According to the Bangladesh Bank, the&#xD;
        inflation rate will also be adjusted with all of our estimates.&#xD;
  &#xD;
        Data analysis to calculate required capacity (Objective 3):&#xD;
  &#xD;
        The investigators will estimate annual influenza vaccine dose and safe-injection equipment&#xD;
        requirements for the target hospitals, adopting the WHO guidelines to calculate vaccine&#xD;
        volumes and cold chain capacity. The investigators will also estimate the required storage&#xD;
        volume, shortage volume for the vaccine, and safe injection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 29, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Our study design will be quasi-experimental. We will run an influenza vaccination campaign before the influenza season, where the vaccine will be offered free of cost to high-risk patients (intervention arm). In the second hospital, vaccination will not be offered (control arm).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>influenza vaccine acceptability</measure>
      <time_frame>one year</time_frame>
      <description>proportion of high-risk group people reported about intention to receive influenza vaccine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>incremental cost-effectiveness ratios (ICERs)</measure>
      <time_frame>one year</time_frame>
      <description>amount per DALYs gained or saved</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>perceived susceptibility and severity</measure>
      <time_frame>one year</time_frame>
      <description>proportion of high-risk group people reported with perceived susceptibility and severity to the influenza virus;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>perceived barriers and benefits</measure>
      <time_frame>one year</time_frame>
      <description>proportion of high-risk group people agreed with perceived barriers and benefits to the vaccine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>required capacity related to vaccine doses</measure>
      <time_frame>one year</time_frame>
      <description>number of annually required vaccine doses</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>required capacity related to self-injection equipment</measure>
      <time_frame>one year</time_frame>
      <description>number of annually required self-injection equipment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>required storage capacity</measure>
      <time_frame>one year</time_frame>
      <description>annually required storage volume in cm3</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2567</enrollment>
    <condition>Influenza Vaccine</condition>
    <condition>Cost-Effectiveness</condition>
    <condition>Vaccination</condition>
    <arm_group>
      <arm_group_label>Influenza vaccination arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the Influenza vaccination hospital, the investigators have run an influenza vaccination campaign before the influenza season, where the vaccines are free to high-risk patients. Posters and leaflets containing information on influenza vaccination have been displayed at the vaccination booths and key hospital locations with information on the vaccination. Eligible patients from inpatients and outpatients of all departments have been offered to take the vaccine during the vaccination campaign. Nurses/ Health Assistants (HA) have provided vaccines after receiving written consent. Vaccination cards have been issued to the participants. All enrolled vaccine recipients are informed about notifying of possible adverse events after immunization (AEFI). To report any AEFI, the investigators are following the existing surveillance channel established by the WHO and the Ministry of Health and Family Welfare(MoHFW), the government of Bangladesh.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm ( unvaccination arm)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>In the control hospital, the investigators are also enrolling participants meeting the high-risk group individual criteria. However, no vaccination campaigns are conducted.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Quadrivalent Influenza Vaccine</intervention_name>
      <description>All high-risk groups have been getting one dose of seasonal influenza vaccination (Inactivated Influenza Vaccine ), except children aged six months to 8 years, who will receive two doses four weeks apart. All vaccines are in the southern hemisphere, as Bangladesh's influenza season matches the southern hemisphere areas.</description>
      <arm_group_label>Influenza vaccination arm</arm_group_label>
      <other_name>Influvax Tetra Vaccine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Participants who will be visiting study hospitals (outpatients and inpatients only.&#xD;
               Not emergency departments) for routine care during the study period.&#xD;
  &#xD;
            -  Participants who will be children six months to 8 years or aged more than 60 years or&#xD;
               pregnant ( any trimester), or have any chronic disease&#xD;
  &#xD;
            -  Participants /parents/caregivers who will be willing to sign the informed consent&#xD;
               form.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Participants with severe, life-threatening allergies to any ingredient in a flu&#xD;
               vaccine (other than egg proteins)&#xD;
  &#xD;
            -  Participants having history of a severe allergic reaction (e.g., anaphylaxis) after a&#xD;
               previous dose of influenza vaccine or to a vaccine component&#xD;
  &#xD;
            -  Participants having a history of guillain-barre syndrome less than 6 weeks after a&#xD;
               previous dose of influenza vaccine&#xD;
  &#xD;
            -  Participants having history of moderate or severe acute illness with or without fever.&#xD;
               The vaccine should be given after the acute condition has improved.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dr. Md. Zakiul Hassan, MSc</last_name>
      <phone>+8801753866573</phone>
      <email>zhassan@icddrb.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Md Abdullah Al Jubayer Biswas, MS</last_name>
      <phone>+8801775016141</phone>
      <email>jubayer.biswas@icddrb.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rajshahi Medical College Hospital</name>
        <address>
          <city>Rajshahi</city>
          <zip>6000</zip>
          <country>Bangladesh</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr Md. Azizul Haque</last_name>
        <phone>+8801715367844</phone>
        <email>drazadbd@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Bangladesh</country>
    </location_countries>
    <link>
      <url>https://www.who.int/news/item/11-03-2019-who-launches-new-global-influenza-strategy</url>
      <description>World Health Organization. WHO launches new global influenza strategy</description>
    </link>
    <link>
      <url>https://apps.who.int/iris/handle/10665/188785</url>
      <description>Hirve, Siddhivinayak &amp; World Health Organization. (2015). Seasonal influenza vaccine use in low and middle income countries in the tropics and subtropics: a systematic review. World Health Organization</description>
    </link>
    <link>
      <url>http://www.bbs.gov.bd/site/page/29855dc1-f2b4-4dc0-9073-f692361112da/Statistical-Yearbook</url>
      <description>Bangladesh Bureau of Statistics.Statistical Yearbook of Bangladesh 2020</description>
    </link>
    <link>
      <url>http://inceptavaccine.com/product-details.php?pid=influvax-</url>
      <description>Incepta Vaccine Ltd.Influvax</description>
    </link>
    <link>
      <url>https://www.mims.com/philippines/drug/info/vaxigrip?type=full</url>
      <description>Sanofi.Vaxigrip</description>
    </link>
    <link>
      <url>https://dhsprogram.com/pubs/pdf/PR104/PR104.pdf</url>
      <description>Bangladesh Demographic and Health Survey 2017-18</description>
    </link>
    <link>
      <url>https://esa.un.org/unpd/wpp/</url>
      <description>World Population Prospects: The 2019 revision. New York: United Nations, Department of Economic and Social Affairs, Population Division</description>
    </link>
    <link>
      <url>https://apps.who.int/iris/handle/10665/345696</url>
      <description>Methods for assessing influenza vaccination coverage in target groups</description>
    </link>
    <link>
      <url>https://apps.who.int/iris/handle/10665/331931</url>
      <description>Flutool plus: WHO seasonal influenza immunization costing tool (SIICT), Pilot version 1.0</description>
    </link>
    <link>
      <url>https://apps.who.int/iris/handle/10665/255203</url>
      <description>Evaluation of influenza vaccine effectiveness: a guide to the design and interpretation of observational studies</description>
    </link>
    <link>
      <url>https://digitallibrary.un.org/record/49698?ln=en</url>
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    <link>
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      <description>World Health Organization. Global health estimates: Leading causes of DALYs</description>
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      <url>https://apps.who.int/iris/handle/10665/337052</url>
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    <link>
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      <citation>Sullivan SG, Price OH, Regan AK. Burden, effectiveness and safety of influenza vaccines in elderly, paediatric and pregnant populations. Ther Adv Vaccines Immunother. 2019 Feb 7;7:2515135519826481. doi: 10.1177/2515135519826481. eCollection 2019.</citation>
      <PMID>30793097</PMID>
    </results_reference>
    <results_reference>
      <citation>Kadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. No abstract available.</citation>
      <PMID>20532100</PMID>
    </results_reference>
    <results_reference>
      <citation>Mangtani P, Cumberland P, Hodgson CR, Roberts JA, Cutts FT, Hall AJ. A cohort study of the effectiveness of influenza vaccine in older people, performed using the United Kingdom general practice research database. J Infect Dis. 2004 Jul 1;190(1):1-10. doi: 10.1086/421274. Epub 2004 May 26.</citation>
      <PMID>15195237</PMID>
    </results_reference>
    <results_reference>
      <citation>Edoka I, Kohli-Lynch C, Fraser H, Hofman K, Tempia S, McMorrow M, Ramkrishna W, Lambach P, Hutubessy R, Cohen C. A cost-effectiveness analysis of South Africa's seasonal influenza vaccination programme. Vaccine. 2021 Jan 8;39(2):412-422. doi: 10.1016/j.vaccine.2020.11.028. Epub 2020 Dec 1.</citation>
      <PMID>33272702</PMID>
    </results_reference>
    <results_reference>
      <citation>Newall AT, Jit M, Hutubessy R. Are current cost-effectiveness thresholds for low- and middle-income countries useful? Examples from the world of vaccines. Pharmacoeconomics. 2014 Jun;32(6):525-31. doi: 10.1007/s40273-014-0162-x.</citation>
      <PMID>24791735</PMID>
    </results_reference>
    <results_reference>
      <citation>Newall AT, Chaiyakunapruk N, Lambach P, Hutubessy RCW. WHO guide on the economic evaluation of influenza vaccination. Influenza Other Respir Viruses. 2018 Mar;12(2):211-219. doi: 10.1111/irv.12510. Epub 2017 Dec 27.</citation>
      <PMID>29024434</PMID>
    </results_reference>
    <results_reference>
      <citation>Fesenfeld M, Hutubessy R, Jit M. Cost-effectiveness of human papillomavirus vaccination in low and middle income countries: a systematic review. Vaccine. 2013 Aug 20;31(37):3786-804. doi: 10.1016/j.vaccine.2013.06.060. Epub 2013 Jul 3.</citation>
      <PMID>23830973</PMID>
    </results_reference>
    <results_reference>
      <citation>Tu HA, Woerdenbag HJ, Kane S, Rozenbaum MH, Li SC, Postma MJ. Economic evaluations of rotavirus immunization for developing countries: a review of the literature. Expert Rev Vaccines. 2011 Jul;10(7):1037-51. doi: 10.1586/erv.11.65.</citation>
      <PMID>21806398</PMID>
    </results_reference>
    <results_reference>
      <citation>McMorrow ML, Tempia S, Walaza S, Treurnicht FK, Ramkrishna W, Azziz-Baumgartner E, Madhi SA, Cohen C. Prioritization of risk groups for influenza vaccination in resource limited settings - A case study from South Africa. Vaccine. 2019 Jan 3;37(1):25-33. doi: 10.1016/j.vaccine.2018.11.048. Epub 2018 Nov 22.</citation>
      <PMID>30471956</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>High-risk group population</keyword>
    <keyword>Facility-Based Seasonal Influenza Vaccination</keyword>
    <keyword>Acceptability</keyword>
    <keyword>Bangladesh</keyword>
    <keyword>Cost-Effectiveness</keyword>
    <keyword>Influenza Vaccine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Influenza, Human</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05996549
  org study id: PR-23014
  nct id: NCT05996549
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Background: In Bangladesh, seasonal influenza imposes considerable health and economic
        burden, particularly for those at high risk of severe disease. To prevent influenza and
        lessen the economic burden, despite the World Health Organization's (WHO) recommendation of
        seasonal influenza vaccination prioritizing high-risk groups, many low-income countries,
        including Bangladesh, lack a national policy/programme and relevant statistics on seasonal
        influenza vaccination.
  
        Objectives:
  
          1. To determine influenza vaccine acceptability, health beliefs, barriers, and intention of
             receiving influenza vaccine among targeted high-risk populations
  
          2. To determine the cost-effectiveness of a seasonal influenza vaccination targeting
             high-risk populations during visits to health facilities for routine care
  
          3. To investigate the required capacity for a potential seasonal influenza vaccination
             programme targeting high-risk populations during their visits to health facilities for
             routine care
  
        Methods: The study will be conducted in three hospitals' inpatient and outpatient departments
        with ongoing hospital-based influenza surveillance (HBIS). To meet objective 1, the
        investigators will collect quantitative data on participants' acceptability, health beliefs,
        barriers, and vaccination intentions using the health belief model (HBM) from patients
        meeting criteria for high-risk populations attending two public tertiary-level hospitals. To
        meet objective 2, in one of the two hospitals, the investigators will run an influenza
        vaccination campaign before the influenza season (the vaccines will be in the southern
        hemisphere), where the vaccine will be offered free of cost to high-risk patients, and in the
        second hospital, vaccination will not be offered. Both the vaccinated and unvaccinated
        participants will then be followed-up for one year period once a month to record any
        influenza-like illness, hospitalization, and death. Additional data for objective two on
        direct and indirect costs associated with influenza illness will be collected from patients
        with influenza-like illness (ILI) and severe acute respiratory infections (SARI) at one
        public and one private hospital. To meet objective 3, the investigators will estimate the
        required number of influenza vaccines, safe injections, and total storage volume utilizing
        secondary data. The investigators will use a deterministic Markov decision-analytic model to
        estimate the cost-effectiveness of facility-based vaccination in Bangladesh.
  Background: Globally, seasonal influenza is a leading cause of morbidity and mortality with
        significant health and economic consequences. According to the World Health Organization
        (WHO), influenza affects around one billion people each year, with 3 to 5 million suffering
        from severe illness, leading to 290,000 to 650,000 deaths each year . The burden of influenza
        illness is significantly higher in low- and middle-income countries (LMICs) than in
        high-income countries (HIC) . Pregnant women, children under five years, and adults with
        co-morbid conditions in LMICs are more likely to get severe influenza illness. In a
        systematic review and meta-analysis of 27 studies found that elderly people were at higher
        risk of death and hospital admission during flu season. That study also found that pregnant
        women and children were at higher risk of developing pneumonia and requiring hospital
        admission; the adults with co-morbidity conditions were at risk of hospitalization and
        intensive care admission during flu seasons.
  
        In order to prevent influenza infection and lessen the severity of the illness, in 2012, the
        WHO advised an annual influenza vaccine dosage for persons at high risk of acquiring a severe
        influenza illness. Despite the WHO recommendation of seasonal influenza vaccination
        prioritizing high-risk groups, 76% of the low-income countries, including Bangladesh, lack a
        national policy/programme on seasonal influenza targeting high-risk groups. Also, the lack of
        context-specific knowledge on the economic burden of influenza vaccines on high-risk groups,
        lack of medical, socio-behavioral patterns, and socio-economic consequences of influenza have
        been identified as challenges for promoting influenza vaccinations in LMICs.
  
        In Bangladesh, around 25 million people of all ages sought outpatient treatment for
        influenza, where the yearly direct cost of influenza-associated outpatient visits was US$ 108
        million. Moreover, approximately 30,592 laboratory-confirmed influenza patients of all ages
        were hospitalized each year, with an estimated annual influenza-associated hospitalization
        cost of US$ 1.4 million. Influenza vaccines are the most reliable method for preventing
        influenza infection. But unfortunately, Bangladesh does not have a national influenza
        vaccination program among the WHO-recommended high-risk population. The Ministry of Health
        and Family Welfare (MoH&FW), Government of the People's Republic of Bangladesh, only offers
        influenza vaccination to all Hajj pilgrims free of cost as part of the mandatory requirement
        for all Hajj pilgrims by the Saudi Government. However, there is a lack of information to
        drive the MoH&FW policy on influenza vaccinations in high-risk populations.
  
        For reducing the influenza disease burden, particularly among high-risk populations,
        influenza vaccination has been proven to be the most effective and cost-effective approach.
        Immune responses elicited by influenza vaccines are generally strain-specific. Antibody
        against one influenza virus type or subtype generally confers limited or no protection
        against another type or subtype, nor does it typically confer protection against antigenic
        variants of the same virus that arise by antigenic drift. However, among adults, vaccination
        can cause a "back boost" of antibody titers against influenza A viruses that have been
        encountered previously either by vaccination or natural infection. Due to antigenic drift and
        shift, influenza vaccines are taken annually with an efficacy between 40-60% varies widely by
        setting and by influenza seasons. In addition, a systematic review of 118 studies on the
        cost-effectiveness of influenza vaccination revealed that 22 of the 118 studies showed
        influenza vaccination to be cost-saving. The study reported cost-effectiveness ratios of
        $10,000/outcome in 13 studies, $10,000 to $50,000 in 13 studies, and ≥$50,000 in 3 studies.
        Despite the fact that influenza vaccination was cost-effective, the cost-effectiveness
        parameters may not be applicable for all countries' contexts because of the differences in
        influenza disease profile, influenza vaccination unit costs, and health system delivery
        mechanisms. Hence, country-specific estimates are essential for the optimal allocation of
        scarce resources.
  
        The investigators extensively searched influenza vaccination cost-effectiveness studies
        targeting high-risk populations in Bangladesh. But to date, there is scarce evidence in
        Bangladesh to inform policymakers about the acceptability, cost-effectiveness, and required
        capacity of influenza vaccination among the WHO-defined high-risk group population.
        Therefore, the investigators propose to generate preliminary data on high-risk groups' health
        beliefs, barriers, and intent to receive the influenza vaccine. The investigators will also
        generate preliminary data on the acceptability, cost-effectiveness, and required capacity for
        a facility-based influenza vaccination program to support policy decisions on influenza
        vaccination in Bangladesh among the high-risk population.
  
        Research Design and Methods:
  
        Study design:
  
        The investigators have been conducting our study leveraging hospital-based influenza
        surveillance (HBIS) ongoing in nine tertiary-level hospitals across Bangladesh. The study
        design is quasi-experimental.
  
        Study sites:
  
        The investigators have chosen study hospitals considering several factors. Firstly, the
        investigators will conduct this study leveraging hospital-based influenza surveillance. The
        investigators have chosen Rajshahi medical college hospital and Khulna medical college
        hospital for study activities related to objectives 1 & 2. To meet objectives 1 & 2, as
        hospital-based influenza surveillance identifies SARI, ILI, or influenza-positive patients,
        it will be helpful to enroll SARI and ILI patients, including those with laboratory-confirmed
        influenza, to collect data on the costs of influenza illness. This approach will save funds
        for influenza testing not allocated in the current study budget. Secondly, to assess the
        outcome of influenza vaccination, the investigators plan to enroll patients from public
        tertiary-level hospitals (one treatment/vaccinated and the other control hospital ) to
        minimize baseline differences between the treatment/vaccinated and control arm. Thirdly, the
        investigators have chosen Ragib-Rabeya Medical College & Hospital to track public and private
        healthcare facility cost differences while estimating the costs of influenza illness.
  
        Study sites for Objective 1:
  
        The investigators have conducted an HBM survey in two conveniently selected hospitals:
  
          1. Rajshahi Medical College Hospital, Rajshahi
  
          2. Khulna Medical College Hospital, Khulna
  
        Study sites for Objective 2:
  
        For objective two, the investigators are collecting data on the health outcome of vaccination
        and the cost associated with influenza illness. Data on health outcomes have been collected
        from two public tertiary-level hospitals (same sites for objective 1). The cost associated
        with influenza illness data has been collected from one public and one private hospital.
  
        Health outcomes of vaccination:
  
          1. Rajshahi Medical College Hospital, Rajshahi
  
          2. Khulna Medical College Hospital, Khulna
  
        Cost associated with influenza illness:
  
          1. Rajshahi Medical College Hospital, Rajshahi
  
          2. Jalalabad Ragib-Rabeya Medical College & Hospital, Sylhet
  
        Study sites for objectives 3:
  
        The investigators will utilize secondary data to estimate the required capacity for seasonal
        influenza vaccination at three hospital catchment areas.
  
        Study population :
  
        Study participants are the WHO-defined four different high-risk groups: children six months
        to 8 years, pregnant women, elderly ≥60 years, and adults with chronic diseases.
  
        Data collection to assess health beliefs, barriers, and intention to receive an influenza
        vaccine (objective 1):
  
        The investigators have collected data on acceptability, health beliefs, obstacles, and
        current intentions to receive the vaccine from enrolled participants. The investigators have
        captured these data using the health belief model (HBM). The questionnaire has been developed
        using an existing literature review. The investigators have included items to assess five
        theoretical constructs of HBM based on reviewing relevant literature, including high-risk
        individual's perceived susceptibility to disease, perceived severity of influenza, perceived
        benefits of the vaccine, perceived barriers to the vaccine, cues to action, and
        self-efficacy. The investigators have conducted face-to-face interviews for the data
        collection.
  
        Data collection to determine the cost-effectiveness of seasonal influenza vaccination
        (objective 2):
  
        Health outcomes of vaccination:
  
        Vaccination campaign:
  
        To record health outcomes after influenza vaccination (objective 2), in one of the two study
        hospitals, the investigators have been running an influenza vaccination campaign before the
        influenza season, where the vaccine has been offering free of cost to high-risk patients.
        Inpatients and outpatients of all departments are informed about the ongoing immunization
        campaign. Eligible patients have been offered to take the vaccine during the vaccination
        campaign. Benefits, significance, adverse effects, and how to manage them have been explained
        to the patients.
  
        In the second hospital, the investigators are enrolling participants meeting the high-risk
        group individual criteria. However, no vaccination campaign will be conducted. The
        investigators have named this group as an unvaccinated cohort (Control Arm).
  
        Follow-up of vaccinated and unvaccinated participants:
  
        The investigators will follow up with vaccinated and unvaccinated study participants
        bi-weekly through mobile phones for the entire influenza season. During the follow-up, data
        will be recorded on health outcomes, including respiratory symptoms, influenza-like illness,
        hospitalization, and death.
  
        Cost associated with influenza illness:
  
        For collecting data on costs associated with influenza illness, the investigators will enroll
        high-risk individuals visiting study hospitals who will meet the SARI and ILI case
        definitions:
  
        Severe acute respiratory illness (SARI): For patients of all ages, a history of or measured
        temperature ≥ 38.0°C and cough began during the last ten days and necessitated
        hospitalization.
  
        Influenza-like illness (ILI): Measured fever above ≥ 38.0°C with cough having an onset within
        the last ten days. The investigators will collect data on the enrolled participants' direct
        and indirect medical costs associated with influenza illness episodes. Cost breakdowns for
        influenza illness episodes are provided below.
  
        Direct medical and non-medical costs for influenza illness episodes:
  
        Direct costs will consist of health care provider fees, hospital registration fees, bed
        rental, prescriptions, laboratory testing, transportation, and mobile phone calls. The
        investigators will also record informal payments made during hospital visits. Costs for all
        medications, laboratory tests, registration, and room rental will also be included. The
        investigators will also collect payment if patients visit a pharmacy or other clinics prior
        to hospitalization. The non-medical expenses for patients or caregivers include food,
        lodging, and transportation. The investigators will collect data directly from patients and
        their families. Members of the participant's family or the participants themselves will be
        able to determine which drugs and tests they received for free (hospital subsidized cost) and
        which they paid for out of pocket (out-of-pocket).
  
        Productivity loss or indirect cost:
  
        The investigators will also collect data on participants' or caregivers', or family members'
        lost productivity and indirect costs incurred during illness. The investigators will record
        the number of workdays missed by participants' family members, participants themselves and
        caregivers due to sickness or family caregiving. The investigators will exclude weekends and
        national holidays from our calculation. Every day missed due to illness or while caring for
        sick family members will be considered a lost workday for hourly-wage workers and housewives.
        The investigators will not consider the days missed due to decreased activity (such as a
        half-day of work), school absences, or influenza-related fatalities.
  
        Costs of durable equipment and other fixed costs:
  
        The investigators are collecting the primary data on the costs of the supplies and materials
        consumed (not purchased and stored) at the hospitals involved in diagnosing and treating
        influenza illness by department, ward, and service, for example, per unit cost and required
        units for blood drawn, x-ray, C-reactive protein, complete blood count, blood culture test,
        widal test etc. The investigators are also collecting data related to health facility
        operating hours ( working hours by ward and department), the ticket price of different
        departments' inpatients or outpatients units, and bed rent.
  
        Collating secondary data for objective 2:
  
        Disability-adjusted life year (DALY):
  
        The investigators will collect secondary data on disability-adjusted life years (DALY) from
        the WHO global health estimation. The investigators will utilize age, and symptoms-specific
        DALY estimates to determine the DALY associated with influenza-related health outcomes.
        Though QALY is widely used for hospital patients, due to the unavailability of publicly
        available QALY data related to influenza or influenza-like illnesses for LMICs, the
        investigators have decided to use the WHO-estimated publicly available DALY estimates for the
        study.
  
        Data sources for estimating influenza-associated disease burden:
  
        To estimate the key parameters of influenza-associated disease burden, such as the number of
        outpatients visits, hospitalization, and deaths, the investigators will collect data from the
        following secondary sources. Assumptions and data sources by each target group are indicated
        below.
  
        Target Study Group 1 (Children 6 months to 8 years) :
  
        Assumption and data sources: Two doses will be delivered, each four weeks apart. Data on the
        total number of <5 years children will be adopted from the Statistical Yearbook of Bangladesh
        2020. Monthly the number of children <8 years visited hospitals will be collected from
        respected hospitals or respective District Civil Surgeon Office.
  
        Target Study Group 2 (Pregnant women) :
  
        Assumption and data sources: One dose to all pregnant women (any trimesters). The crude birth
        rate is assumed to be 21.9% (BDHS 2017-18). Influenza vaccines were distributed evenly across
        the childbearing years 15 through 49. Data on the total number of women of childbearing age
        (15-49 years) will be collected from the Statistical Yearbook of Bangladesh 2020. Monthly
        pregnant women who visited hospitals will be collected from respective hospitals or
        respective District Civil Surgeon Office.
  
        Target Study Group 3 (Elderly ≥60 years) :
  
        Assumption and data sources: One dose for all persons aged 60 years and older. Population
        data from the Statistical Yearbook of Bangladesh 2020. Monthly the total number of ≥60 years
        aged patients visited hospitals will be collected from respected hospitals or respective
        District Civil Surgeon Office.
  
        Target Study Group 4 (Adults with chronic diseases):
  
        Assumption and data sources: One dose for all persons with chronic disease. The investigators
        will use the prevalence of having any chronic illness from the Bangladesh Household Income
        and Expenditure Survey (HIES) 2010. Then, the total number of persons with any chronic
        illness will be estimated using data from the Statistical Yearbook of Bangladesh 2020.
        Monthly patients with chronic diseases visited hospitals will be collected from respected
        hospitals or respective District Civil Surgeon Office.
  
        Vaccine coverage:
  
        The investigators will use secondary data for the input parameters relating to seasonal
        influenza vaccination coverage in Bangladesh. The investigators will extract information on
        hospitals' catchment areas' population size from the Statistical Yearbook of Bangladesh 2020.
  
        Vaccine adverse event costs:
  
        Vaccine adverse event costs will be estimated for each targeted risk group. Using primary and
        secondary data, the investigators will estimate the costs of influenza vaccination adverse
        events. The investigators will use secondary data to estimate influenza vaccination rates and
        adverse events, whereas primary data will be used to determine the cost.
  
        Data collection to estimate the required capacity of a hospital-based influenza vaccination
        programme (objective 3):
  
        The investigators will collect secondary data to calculate the requirements capacity at each
        hospital. Secondary data will be collected about the population size of the targeted risk
        group in the hospital's catchment area, the number of doses required for vaccinating each
        high-risk individual, the number of doses per vial, packed volume, doses syringes, and safety
        box.
  
        Sample Size Calculation:
  
        The sample size for vaccine acceptability: Primary outcome of this study for vaccine
        acceptability is the intention to receive the influenza vaccine. According to high-risk
        group-specific health belief model studies from neighboring countries, 91% of elderly people,
        88% of adults with chronic illness, 76.3% of pregnant women, and 62.4% of parents with
        six-month-to-three-year-olds intended to get the influenza vaccine. The investigators expect
        a similar positive intention to receive the influenza vaccine, ranging from 62% to 91% for
        our target study population. The investigators utilize a 5% significance level, 80% power,
        design effect of 1.2, and 10% non-response to estimate the sample size. The estimated sample
        size by the high-risk group for vaccine acceptability (objective 1) is given below.
  
        The sample size for children six months to 8 years = 659 The sample size for pregnant women =
        495 The sample size for Elderly ≥60 years = 330 The sample size for adults with chronic
        diseases = 425
  
        The sample size for vaccine effectiveness: Next outcome for health outcome for vaccination is
        vaccine efficacy against influenza-like illness among high-risk group populations. Studies
        from neighboring countries found that ILI symptoms were 15.30% of children, 31.23% of adults
        with chronic illness, 10.97% of pregnant women, and 20% of the elderly. A systematic review
        of seasonal influenza vaccine policy, use, and efficacy also revealed that pooled vaccine
        efficacy for high-risk groups in the tropics and subtropics ranged from 48% to 88%. The
        investigators expect a similar vaccine efficacy between 50%-81% for our study's targeted
        high-risk group population. The investigators also assume a 5% significance level, 80% power,
        design effect of 1.2, and 10% non-response to estimate the sample size. The high-risk group's
        estimated sample size for vaccine effectiveness is given below.
  
        The sample size for children six months to 8 years = 465 The sample size for pregnant women =
        756 The sample size for Elderly ≥60 years = 736 The sample size for adults with chronic
        diseases = 610
  
        The sample size for the cost-components survey: Another outcome for costs-components is the
        total influenza-associated illness costs among high-risk group populations. A study in
        Bangladesh on the economic evaluation of influenza-associated disease estimated that the
        total direct cost of influenza-associated illness was 7,614 TK for children under five years,
        followed by 20,808Tk for pregnant women, 13,761 TK for elderly and 8,222 TK for adults with
        chronic diseases. The investigators expect a similar total direct cost of
        influenza-associated illness of 7,614Tk-20,808Tk for our study's targeted high-risk group
        population. Other than that, the investigators utilize a 5% significance level, 80% power,
        design effect of 1.2, and 10% non-response to estimate the sample size. The high-risk group's
        estimated sample size for the cost-components survey is given below.
  
        The sample size for children six months to 8 years = 60 The sample size for pregnant women =
        39 The sample size for the Elderly ≥60 years = 56 The sample size for adults with chronic
        diseases = 31
  
        Data Analysis:
  
        The investigators will summarize all the data by descriptive statistics tools, including
        frequency, percentage, mean, median, standard deviation (SD), and interquartile range (25th
        percentile - 75th percentile).
  
        Objective specific data analysis plan is as follows:
  
        Data analysis on the propensity to vaccine using results from the HBM survey (Objective 1):
  
        In each of the five HBM constructs, the investigators will use factor analysis using the
        principal axis factor technique and varimax rotation to find latent variables and minimize
        the number of independent variables. The Kaiser-Meyer-Olkin test will be used to determine
        sample adequacy. The investigators will also use Cronbach's alpha to test the internal
        consistency of survey items.
  
        Data analysis for cost-effectiveness analysis (Objective 2):
  
        Vaccine efficacy estimation:
  
        The investigators will utilize Poisson regression to obtain rate ratios (RRs) for vaccinated
        and unvaccinated individuals against influenza. In the final model, the investigators will
        include all the variables that will be found to have a confounding effect or found to be
        significant at a 5% level of significance. The investigators will calculate vaccine
        effectiveness with 95% CI for each risk group ( (1 - RR) * 100) ).
  
        Cost-effectiveness estimation:
  
        To estimate the pilot influenza vaccination cost-effectiveness targeted for the high-risk
        group, the investigators will use the built-in formulas of the CETSIV tool. Besides, the
        investigators will recheck the outputs by developing a deterministic Markov decision-analytic
        model to simulate outcomes under alternative assumptions of input parameters. The
        investigators will conduct a probabilistic sensitivity analysis (PSA) to see how parameter
        estimation precision uncertainty affects the model's outcome. If ICER is below less than
        three times the gross domestic product (GDP) per capita, the investigators will consider the
        vaccination as cost-effective, as per the WHO standard.
  
        Vaccination cost estimation: The financial and economic costs of the vaccination programme
        will be collected using the WHO seasonal influenza immunization costing tool (SIICT). The WHO
        seasonal influenza immunization costing tool (SIICT) was updated in 2020 and was newly named
        The WHO Flutool Plus. The investigators will use the newly developed WHO Flutool Plus and
        customize all the components for the facility-based vaccination. However, the investigators
        assume a discount rate of 5%. Bangladesh Bank Dollars exchange rate of 105 to 110 TK will be
        used to represent the findings at all estimates. According to the Bangladesh Bank, the
        inflation rate will also be adjusted with all of our estimates.
  
        Data analysis to calculate required capacity (Objective 3):
  
        The investigators will estimate annual influenza vaccine dose and safe-injection equipment
        requirements for the target hospitals, adopting the WHO guidelines to calculate vaccine
        volumes and cold chain capacity. The investigators will also estimate the required storage
        volume, shortage volume for the vaccine, and safe injection.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Our study design will be quasi-experimental. We will run an influenza vaccination campaign before the influenza season, where the vaccine will be offered free of cost to high-risk patients (intervention arm). In the second hospital, vaccination will not be offered (control arm).
  primary purpose: Prevention
  masking: Single (Investigator)
  measure: influenza vaccine acceptability
  time frame: one year
  description: proportion of high-risk group people reported about intention to receive influenza vaccine
  measure: incremental cost-effectiveness ratios (ICERs)
  time frame: one year
  description: amount per DALYs gained or saved
  measure: perceived susceptibility and severity
  time frame: one year
  description: proportion of high-risk group people reported with perceived susceptibility and severity to the influenza virus;
  measure: perceived barriers and benefits
  time frame: one year
  description: proportion of high-risk group people agreed with perceived barriers and benefits to the vaccine
  measure: required capacity related to vaccine doses
  time frame: one year
  description: number of annually required vaccine doses
  measure: required capacity related to self-injection equipment
  time frame: one year
  description: number of annually required self-injection equipment
  measure: required storage capacity
  time frame: one year
  description: annually required storage volume in cm3
  arm group label: Influenza vaccination arm
  arm group type: Experimental
  description: In the Influenza vaccination hospital, the investigators have run an influenza vaccination campaign before the influenza season, where the vaccines are free to high-risk patients. Posters and leaflets containing information on influenza vaccination have been displayed at the vaccination booths and key hospital locations with information on the vaccination. Eligible patients from inpatients and outpatients of all departments have been offered to take the vaccine during the vaccination campaign. Nurses/ Health Assistants (HA) have provided vaccines after receiving written consent. Vaccination cards have been issued to the participants. All enrolled vaccine recipients are informed about notifying of possible adverse events after immunization (AEFI). To report any AEFI, the investigators are following the existing surveillance channel established by the WHO and the Ministry of Health and Family Welfare(MoHFW), the government of Bangladesh.
  arm group label: Control arm ( unvaccination arm)
  arm group type: No Intervention
  description: In the control hospital, the investigators are also enrolling participants meeting the high-risk group individual criteria. However, no vaccination campaigns are conducted.
  intervention type: Drug
  intervention name: Quadrivalent Influenza Vaccine
  description: All high-risk groups have been getting one dose of seasonal influenza vaccination (Inactivated Influenza Vaccine ), except children aged six months to 8 years, who will receive two doses four weeks apart. All vaccines are in the southern hemisphere, as Bangladesh's influenza season matches the southern hemisphere areas.
  arm group label: Influenza vaccination arm
  other name: Influvax Tetra Vaccine
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: N/A
  healthy volunteers: No
  last name: Dr. Md. Zakiul Hassan, MSc
  phone: +8801753866573
  email: zhassan@icddrb.org
  last name: Md Abdullah Al Jubayer Biswas, MS
  phone: +8801775016141
  email: jubayer.biswas@icddrb.org
  facility: 
  status: Recruiting
  contact: 
  country: Bangladesh
  url: https://www.who.int/news/item/11-03-2019-who-launches-new-global-influenza-strategy
  description: World Health Organization. WHO launches new global influenza strategy
  url: https://apps.who.int/iris/handle/10665/188785
  description: Hirve, Siddhivinayak & World Health Organization. (2015). Seasonal influenza vaccine use in low and middle income countries in the tropics and subtropics: a systematic review. World Health Organization
  url: http://www.bbs.gov.bd/site/page/29855dc1-f2b4-4dc0-9073-f692361112da/Statistical-Yearbook
  description: Bangladesh Bureau of Statistics.Statistical Yearbook of Bangladesh 2020
  url: http://inceptavaccine.com/product-details.php?pid=influvax-
  description: Incepta Vaccine Ltd.Influvax
  url: https://www.mims.com/philippines/drug/info/vaxigrip?type=full
  description: Sanofi.Vaxigrip
  url: https://dhsprogram.com/pubs/pdf/PR104/PR104.pdf
  description: Bangladesh Demographic and Health Survey 2017-18
  url: https://esa.un.org/unpd/wpp/
  description: World Population Prospects: The 2019 revision. New York: United Nations, Department of Economic and Social Affairs, Population Division
  url: https://apps.who.int/iris/handle/10665/345696
  description: Methods for assessing influenza vaccination coverage in target groups
  url: https://apps.who.int/iris/handle/10665/331931
  description: Flutool plus: WHO seasonal influenza immunization costing tool (SIICT), Pilot version 1.0
  url: https://apps.who.int/iris/handle/10665/255203
  description: Evaluation of influenza vaccine effectiveness: a guide to the design and interpretation of observational studies
  url: https://digitallibrary.un.org/record/49698?ln=en
  description: Adequacy of sample size in health studies / Stanley Lemeshow...[et al.]
  url: https://books.google.com.bd/books/about/Multivariate_Data_Analysis.html?id=SLRPLgAACAAJ&redir_esc=y
  description: Multivariate Data Analysis: A Global Perspective
  url: https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates/global-health-estimates-leading-causes-of-dalys
  description: World Health Organization. Global health estimates: Leading causes of DALYs
  url: https://apps.who.int/iris/handle/10665/337052
  description: Training for mid-level managers (MLM): module 1: cold chain, vaccines and safe-injection equipment management
  url: https://apps.who.int/iris/handle/10665/67342
  description: Guidelines for estimating costs of introducing new vaccines into the national immunization system
  url: https://www.bb.org.bd/en/index.php/econdata/exchangerate
  description: Bangladesh Bank . Exchange rate of Taka
  url: https://www.bb.org.bd/en/index.php/econdata/inflation
  description: Bangladesh Bank . Current Inflation
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  responsible party type: Sponsor
  mesh term: Influenza, Human
  mesh term: Vaccines
  sharing ipd: No