Clinical trial
Acceptability, Cost-Effectiveness, and Capacity of a Facility-Based Seasonal Influenza Vaccination: A Study in Selected Hospitals of Bangladesh
Name
PR-23014
Description
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.
Trial arms
Trial start
2022-09-29
Estimated PCD
2024-07-31
Trial end
2024-09-30
Status
Recruiting
Phase
Early phase I
Treatment
Quadrivalent Influenza Vaccine
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.
Arms:
Influenza vaccination arm
Other names:
Influvax Tetra Vaccine
Size
2567
Primary endpoint
influenza vaccine acceptability
one year
incremental cost-effectiveness ratios (ICERs)
one year
Eligibility criteria
Inclusion criteria:
* Participants who will be visiting study hospitals (outpatients and inpatients only. Not emergency departments) for routine care during the study period.
* Participants who will be children six months to 8 years or aged more than 60 years or pregnant ( any trimester), or have any chronic disease
* Participants /parents/caregivers who will be willing to sign the informed consent form.
Exclusion criteria:
* Participants with severe, life-threatening allergies to any ingredient in a flu vaccine (other than egg proteins)
* Participants having history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of influenza vaccine or to a vaccine component
* Participants having a history of guillain-barre syndrome less than 6 weeks after a previous dose of influenza vaccine
* Participants having history of moderate or severe acute illness with or without fever. The vaccine should be given after the acute condition has improved.
Protocol
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Updated at
2023-08-18
1 organization