Cost-effectiveness of the Influenza Vaccination
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|ClinicalTrials.gov Identifier: NCT05996549|
Recruitment Status : Recruiting
First Posted : August 18, 2023
Last Update Posted : August 18, 2023
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.
- To determine influenza vaccine acceptability, health beliefs, barriers, and intention of receiving influenza vaccine among targeted high-risk populations
- To determine the cost-effectiveness of a seasonal influenza vaccination targeting high-risk populations during visits to health facilities for routine care
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza Vaccine Cost-Effectiveness Vaccination||Drug: Quadrivalent Influenza Vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2567 participants|
|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).|
|Official Title:||Acceptability, Cost-Effectiveness, and Capacity of a Facility-Based Seasonal Influenza Vaccination: A Study in Selected Hospitals of Bangladesh|
|Actual Study Start Date :||September 29, 2022|
|Estimated Primary Completion Date :||July 31, 2024|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Influenza vaccination arm
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.
Drug: 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.
Other Name: Influvax Tetra Vaccine
No Intervention: Control arm ( unvaccination arm)
In the control hospital, the investigators are also enrolling participants meeting the high-risk group individual criteria. However, no vaccination campaigns are conducted.
- influenza vaccine acceptability [ Time Frame: one year ]proportion of high-risk group people reported about intention to receive influenza vaccine
- incremental cost-effectiveness ratios (ICERs) [ Time Frame: one year ]amount per DALYs gained or saved
- perceived susceptibility and severity [ Time Frame: one year ]proportion of high-risk group people reported with perceived susceptibility and severity to the influenza virus;
- perceived barriers and benefits [ Time Frame: one year ]proportion of high-risk group people agreed with perceived barriers and benefits to the vaccine
- required capacity related to vaccine doses [ Time Frame: one year ]number of annually required vaccine doses
- required capacity related to self-injection equipment [ Time Frame: one year ]number of annually required self-injection equipment
- required storage capacity [ Time Frame: one year ]annually required storage volume in cm3
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05996549
|Contact: Dr. Md. Zakiul Hassan, MScfirstname.lastname@example.org|
|Contact: Md Abdullah Al Jubayer Biswas, MSemail@example.com|
|Rajshahi Medical College Hospital||Recruiting|
|Rajshahi, Bangladesh, 6000|
|Contact: Dr Md. Azizul Haque +8801715367844 firstname.lastname@example.org|