NCT05996549

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. 1.To determine influenza vaccine acceptability, health beliefs, barriers, and intention of receiving influenza vaccine among targeted high-risk populations
  2. 2.To determine the cost-effectiveness of a seasonal influenza vaccination targeting high-risk populations during visits to health facilities for routine care
  3. 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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,567

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1.8 years

First QC Date

July 26, 2023

Last Update Submit

August 13, 2023

Conditions

Keywords

High-risk group populationFacility-Based Seasonal Influenza VaccinationAcceptabilityBangladeshCost-EffectivenessInfluenza Vaccine

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

EXPERIMENTAL

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

Control arm ( unvaccination arm)

NO INTERVENTION

In 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.

Also known as: Influvax Tetra Vaccine
Influenza vaccination arm

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

Rajshahi Medical College Hospital

Rajshahi, 6000, Bangladesh

RECRUITING

Related Publications (47)

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Related Links

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Central Study Contacts

Dr. Md. Zakiul Hassan, MSc

CONTACT

Md Abdullah Al Jubayer Biswas, MS

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
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

Locations