Cost-effectiveness of the Influenza Vaccination
Acceptability, Cost-Effectiveness, and Capacity of a Facility-Based Seasonal Influenza Vaccination: A Study in Selected Hospitals of Bangladesh
1 other identifier
interventional
2,567
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 29, 2022
CompletedFirst Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedAugust 18, 2023
July 1, 2023
1.8 years
July 26, 2023
August 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
influenza vaccine acceptability
proportion of high-risk group people reported about intention to receive influenza vaccine
one year
incremental cost-effectiveness ratios (ICERs)
amount per DALYs gained or saved
one year
Secondary Outcomes (5)
perceived susceptibility and severity
one year
perceived barriers and benefits
one year
required capacity related to vaccine doses
one year
required capacity related to self-injection equipment
one year
required storage capacity
one year
Study Arms (2)
Influenza vaccination arm
EXPERIMENTALIn 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.
Control arm ( unvaccination arm)
NO INTERVENTIONIn the control hospital, the investigators are also enrolling participants meeting the high-risk group individual criteria. However, no vaccination campaigns are conducted.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladeshlead
- Centers for Disease Control and Preventioncollaborator
- Institute of Epidemiology, Disease Control and Researchcollaborator
- Rajshahi Medical College Hospital, Rajshahi , Bangladeshcollaborator
- Khulna Medical College Hospital, Khulna, Bangladeshcollaborator
- Jalalabad Ragib-Rabeya Medical College & Hospital, Sylhet, Bangladeshcollaborator
Study Sites (1)
Rajshahi Medical College Hospital
Rajshahi, 6000, Bangladesh
Related Publications (47)
Nichol KL. Cost-effectiveness and socio-economic aspects of childhood influenza vaccination. Vaccine. 2011 Oct 6;29(43):7554-8. doi: 10.1016/j.vaccine.2011.08.015. Epub 2011 Aug 4.
PMID: 21820477RESULTSimonsen L. The global impact of influenza on morbidity and mortality. Vaccine. 1999 Jul 30;17 Suppl 1:S3-10. doi: 10.1016/s0264-410x(99)00099-7. No abstract available.
PMID: 10471173RESULTBhuiyan MU, Luby SP, Alamgir NI, Homaira N, Mamun AA, Khan JA, Abedin J, Sturm-Ramirez K, Gurley ES, Zaman RU, Alamgir AS, Rahman M, Widdowson MA, Azziz-Baumgartner E. Economic burden of influenza-associated hospitalizations and outpatient visits in Bangladesh during 2010. Influenza Other Respir Viruses. 2014 Jul;8(4):406-13. doi: 10.1111/irv.12254. Epub 2014 Apr 22.
PMID: 24750586RESULTColeman BL, Fadel SA, Fitzpatrick T, Thomas SM. Risk factors for serious outcomes associated with influenza illness in high- versus low- and middle-income countries: Systematic literature review and meta-analysis. Influenza Other Respir Viruses. 2018 Jan;12(1):22-29. doi: 10.1111/irv.12504. Epub 2017 Dec 2.
PMID: 29197154RESULTMertz D, Kim TH, Johnstone J, Lam PP, Science M, Kuster SP, Fadel SA, Tran D, Fernandez E, Bhatnagar N, Loeb M. Populations at risk for severe or complicated influenza illness: systematic review and meta-analysis. BMJ. 2013 Aug 23;347:f5061. doi: 10.1136/bmj.f5061.
PMID: 23974637RESULTVaccines against influenza WHO position paper - November 2012. Wkly Epidemiol Rec. 2012 Nov 23;87(47):461-76. No abstract available. English, French.
PMID: 23210147RESULTHirve S, Lambach P, Paget J, Vandemaele K, Fitzner J, Zhang W. Seasonal influenza vaccine policy, use and effectiveness in the tropics and subtropics - a systematic literature review. Influenza Other Respir Viruses. 2016 Jul;10(4):254-67. doi: 10.1111/irv.12374. Epub 2016 May 26.
PMID: 26842617RESULTOrtiz JR, Perut M, Dumolard L, Wijesinghe PR, Jorgensen P, Ropero AM, Danovaro-Holliday MC, Heffelfinger JD, Tevi-Benissan C, Teleb NA, Lambach P, Hombach J. A global review of national influenza immunization policies: Analysis of the 2014 WHO/UNICEF Joint Reporting Form on immunization. Vaccine. 2016 Oct 26;34(45):5400-5405. doi: 10.1016/j.vaccine.2016.07.045. Epub 2016 Sep 16.
PMID: 27646030RESULTSibanda M, Meyer JC, Godman B, Burnett RJ. Low influenza vaccine uptake by healthcare workers caring for the elderly in South African old age homes and primary healthcare facilities. BMC Public Health. 2023 Jan 12;23(1):91. doi: 10.1186/s12889-022-14926-8.
PMID: 36635715RESULTChen H, Li Q, Zhang M, Gu Z, Zhou X, Cao H, Wu F, Liang M, Zheng L, Xian J, Chen Q, Lin Q. Factors associated with influenza vaccination coverage and willingness in the elderly with chronic diseases in Shenzhen, China. Hum Vaccin Immunother. 2022 Nov 30;18(6):2133912. doi: 10.1080/21645515.2022.2133912. Epub 2022 Oct 21.
PMID: 36269145RESULTWiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, Leask J. Uptake of influenza vaccine by pregnant women: a cross-sectional survey. Med J Aust. 2013 Apr 15;198(7):373-5. doi: 10.5694/mja12.11849.
PMID: 23581957RESULTMarrie RA, Walld R, Bolton JM, Sareen J, Patten SB, Singer A, Lix LM, Hitchon CA, Marriott JJ, El-Gabalawy R, Katz A, Fisk JD, Bernstein CN; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Uptake of influenza vaccination among persons with inflammatory bowel disease, multiple sclerosis or rheumatoid arthritis: a population-based matched cohort study. CMAJ Open. 2021 May 14;9(2):E510-E521. doi: 10.9778/cmajo.20200105. Print 2021 Apr-Jun.
PMID: 33990365RESULTOrtiz JR, Neuzil KM. Influenza Immunization in Low- and Middle-Income Countries: Preparing for Next-Generation Influenza Vaccines. J Infect Dis. 2019 Apr 8;219(Suppl_1):S97-S106. doi: 10.1093/infdis/jiz024.
PMID: 30715348RESULTOtt JJ, Klein Breteler J, Tam JS, Hutubessy RC, Jit M, de Boer MR. Influenza vaccines in low and middle income countries: a systematic review of economic evaluations. Hum Vaccin Immunother. 2013 Jul;9(7):1500-11. doi: 10.4161/hv.24704. Epub 2013 May 31.
PMID: 23732900RESULTAhmed M, Aleem MA, Roguski K, Abedin J, Islam A, Alam KF, Gurley ES, Rahman M, Azziz-Baumgartner E, Homaira N, Sturm-Ramirez K, Danielle Iuliano A. Estimates of seasonal influenza-associated mortality in Bangladesh, 2010-2012. Influenza Other Respir Viruses. 2018 Jan;12(1):65-71. doi: 10.1111/irv.12490. Epub 2017 Dec 2.
PMID: 29197174RESULTAzziz-Baumgartner E, Alamgir AS, Rahman M, Homaira N, Sohel BM, Sharker MA, Zaman RU, Dee J, Gurley ES, Al Mamun A, Mah-E-Muneer S, Fry AM, Widdowson MA, Bresee J, Lindstrom S, Azim T, Brooks A, Podder G, Hossain MJ, Rahman M, Luby SP. Incidence of influenza-like illness and severe acute respiratory infection during three influenza seasons in Bangladesh, 2008-2010. Bull World Health Organ. 2012 Jan 1;90(1):12-9. doi: 10.2471/BLT.11.090209. Epub 2011 Oct 4.
PMID: 22271960RESULTWorld Health Organization. Health conditions for travellers to Saudi Arabia pilgrimage to Mecca (Hajj). Wkly Epidemiol Rec. 2005 Dec 9;80(49-50):431-2. No abstract available. English, French.
PMID: 16372666RESULTBarberis I, Myles P, Ault SK, Bragazzi NL, Martini M. History and evolution of influenza control through vaccination: from the first monovalent vaccine to universal vaccines. J Prev Med Hyg. 2016 Sep;57(3):E115-E120.
PMID: 27980374RESULTGasparini R, Amicizia D, Lai PL, Bragazzi NL, Panatto D. Compounds with anti-influenza activity: present and future of strategies for the optimal treatment and management of influenza. Part I: Influenza life-cycle and currently available drugs. J Prev Med Hyg. 2014 Sep;55(3):69-85.
PMID: 25902573RESULTPeasah SK, Azziz-Baumgartner E, Breese J, Meltzer MI, Widdowson MA. Influenza cost and cost-effectiveness studies globally--a review. Vaccine. 2013 Nov 4;31(46):5339-48. doi: 10.1016/j.vaccine.2013.09.013. Epub 2013 Sep 19.
PMID: 24055351RESULTDilokthornsakul P, Lan LM, Thakkinstian A, Hutubessy R, Lambach P, Chaiyakunapruk N. Economic evaluation of seasonal influenza vaccination in elderly and health workers: A systematic review and meta-analysis. EClinicalMedicine. 2022 Apr 21;47:101410. doi: 10.1016/j.eclinm.2022.101410. eCollection 2022 May.
PMID: 35497069RESULTMahmud I, Kabir R, Rahman MA, Alradie-Mohamed A, Vinnakota D, Al-Mohaimeed A. The Health Belief Model Predicts Intention to Receive the COVID-19 Vaccine in Saudi Arabia: Results from a Cross-Sectional Survey. Vaccines (Basel). 2021 Aug 5;9(8):864. doi: 10.3390/vaccines9080864.
PMID: 34451991RESULTMo PK, Lau JT. Influenza vaccination uptake and associated factors among elderly population in Hong Kong: the application of the Health Belief Model. Health Educ Res. 2015 Oct;30(5):706-18. doi: 10.1093/her/cyv038. Epub 2015 Sep 3.
PMID: 26336905RESULTNexoe J, Kragstrup J, Sogaard J. Decision on influenza vaccination among the elderly. A questionnaire study based on the Health Belief Model and the Multidimensional Locus of Control Theory. Scand J Prim Health Care. 1999 Jun;17(2):105-10. doi: 10.1080/028134399750002737.
PMID: 10439494RESULTArsenovic S, Trajkovic G, Pekmezovic T, Gazibara T. Validity of the Health Belief Model Applied to Influenza among people with chronic diseases: Is it time to develop a new knowledge domain? PLoS One. 2022 Sep 15;17(9):e0274739. doi: 10.1371/journal.pone.0274739. eCollection 2022.
PMID: 36108085RESULTHu Y, Wang Y, Liang H, Chen Y. Seasonal Influenza Vaccine Acceptance among Pregnant Women in Zhejiang Province, China: Evidence Based on Health Belief Model. Int J Environ Res Public Health. 2017 Dec 11;14(12):1551. doi: 10.3390/ijerph14121551.
PMID: 29232882RESULTTrent MJ, Salmon DA, MacIntyre CR. Using the health belief model to identify barriers to seasonal influenza vaccination among Australian adults in 2019. Influenza Other Respir Viruses. 2021 Sep;15(5):678-687. doi: 10.1111/irv.12843. Epub 2021 Feb 15.
PMID: 33586871RESULTCOMMITTEE ON INFECTIOUS DISEASES. Recommendations for Prevention and Control of Influenza in Children, 2021-2022. Pediatrics. 2021 Oct;148(4):e2021053745. doi: 10.1542/peds.2021-053745. Epub 2021 Sep 7.
PMID: 34493538RESULTPecenka C, Parashar U, Tate JE, Khan JAM, Groman D, Chacko S, Shamsuzzaman M, Clark A, Atherly D. Impact and cost-effectiveness of rotavirus vaccination in Bangladesh. Vaccine. 2017 Jul 13;35(32):3982-3987. doi: 10.1016/j.vaccine.2017.05.087. Epub 2017 Jun 13.
PMID: 28623028RESULTVan Minh H, My NTT, Jit M. Cervical cancer treatment costs and cost-effectiveness analysis of human papillomavirus vaccination in Vietnam: a PRIME modeling study. BMC Health Serv Res. 2017 May 15;17(1):353. doi: 10.1186/s12913-017-2297-x.
PMID: 28506297RESULTSultana M, Mahumud RA, Sarker AR. Burden of chronic illness and associated disabilities in Bangladesh: Evidence from the Household Income and Expenditure Survey. Chronic Dis Transl Med. 2017 Apr 17;3(2):112-122. doi: 10.1016/j.cdtm.2017.02.001. eCollection 2017 Jun 25.
PMID: 29063064RESULTDemicheli V, Jefferson T, Di Pietrantonj C, Ferroni E, Thorning S, Thomas RE, Rivetti A. Vaccines for preventing influenza in the elderly. Cochrane Database Syst Rev. 2018 Feb 1;2(2):CD004876. doi: 10.1002/14651858.CD004876.pub4.
PMID: 29388197RESULTJefferson T, Rivetti A, Harnden A, Di Pietrantonj C, Demicheli V. Vaccines for preventing influenza in healthy children. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004879. doi: 10.1002/14651858.CD004879.pub3.
PMID: 18425905RESULTRolfes MA, Goswami D, Sharmeen AT, Yeasmin S, Parvin N, Nahar K, Rahman M, Barends M, Ahmed D, Rahman MZ, Bresee J, Luby S, Moulton LH, Santosham M, Fry AM, Brooks WA. Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh. Vaccine. 2017 Dec 15;35(50):6967-6976. doi: 10.1016/j.vaccine.2017.10.074. Epub 2017 Oct 31.
PMID: 29100706RESULTRandomised trial of plasma exchange, intravenous immunoglobulin, and combined treatments in Guillain-Barre syndrome. Plasma Exchange/Sandoglobulin Guillain-Barre Syndrome Trial Group. Lancet. 1997 Jan 25;349(9047):225-30.
PMID: 9014908RESULTBrooks WA, Zaman K, Lewis KD, Ortiz JR, Goswami D, Feser J, Sharmeen AT, Nahar K, Rahman M, Rahman MZ, Barin B, Yunus M, Fry AM, Bresee J, Azim T, Neuzil KM. Efficacy of a Russian-backbone live attenuated influenza vaccine among young children in Bangladesh: a randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2016 Dec;4(12):e946-e954. doi: 10.1016/S2214-109X(16)30200-5. Epub 2016 Oct 13.
PMID: 27746226RESULTFell DB, Azziz-Baumgartner E, Baker MG, Batra M, Beaute J, Beutels P, Bhat N, Bhutta ZA, Cohen C, De Mucio B, Gessner BD, Gravett MG, Katz MA, Knight M, Lee VJ, Loeb M, Luteijn JM, Marshall H, Nair H, Pottie K, Salam RA, Savitz DA, Serruya SJ, Skidmore B, Ortiz JR; WHO taskforce to evaluate influenza data to inform vaccine impact and economic modelling. Influenza epidemiology and immunization during pregnancy: Final report of a World Health Organization working group. Vaccine. 2017 Oct 13;35(43):5738-5750. doi: 10.1016/j.vaccine.2017.08.037. Epub 2017 Sep 1.
PMID: 28867508RESULTSullivan 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.
PMID: 30793097RESULTKadam 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.
PMID: 20532100RESULTMangtani 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.
PMID: 15195237RESULTEdoka 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.
PMID: 33272702RESULTNewall 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.
PMID: 24791735RESULTNewall 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.
PMID: 29024434RESULTFesenfeld 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.
PMID: 23830973RESULTTu 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.
PMID: 21806398RESULTMcMorrow 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.
PMID: 30471956RESULTHassan MZ, Biswas MAAJ, Rahman M, Shoshi HR, Pyash AS, Islam MA, Haque MA, Parvin SR, Hossen MT, Hussain M, Rahman M, Shirin T, Chowdhury F. Acceptability, cost-effectiveness, and capacity of a facility-based seasonal influenza vaccination among high-risk groups: a study protocol in selected tertiary care hospitals of Bangladesh. BMC Public Health. 2024 Jan 20;24(1):242. doi: 10.1186/s12889-024-17724-6.
PMID: 38245668DERIVED
Related Links
- World Health Organization. WHO launches new global influenza strategy
- 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
- Bangladesh Bureau of Statistics.Statistical Yearbook of Bangladesh 2020
- Incepta Vaccine Ltd.Influvax
- Sanofi.Vaxigrip
- Bangladesh Demographic and Health Survey 2017-18
- World Population Prospects: The 2019 revision. New York: United Nations, Department of Economic and Social Affairs, Population Division
- Methods for assessing influenza vaccination coverage in target groups
- Flutool plus: WHO seasonal influenza immunization costing tool (SIICT), Pilot version 1.0
- Evaluation of influenza vaccine effectiveness: a guide to the design and interpretation of observational studies
- Adequacy of sample size in health studies / Stanley Lemeshow...\[et al.\]
- Multivariate Data Analysis: A Global Perspective
- World Health Organization. Global health estimates: Leading causes of DALYs
- Training for mid-level managers (MLM): module 1: cold chain, vaccines and safe-injection equipment management
- Guidelines for estimating costs of introducing new vaccines into the national immunization system
- Bangladesh Bank . Exchange rate of Taka
- Bangladesh Bank . Current Inflation
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2023
First Posted
August 18, 2023
Study Start
September 29, 2022
Primary Completion
July 31, 2024
Study Completion
September 30, 2024
Last Updated
August 18, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share