An Effectiveness Trial to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh

NCT04998344 | Active Not Recruiting Phase 4

• 1 other identifier: PR-19103
• Study Type: interventional
• Target: 3,800
• Locations: 2 countries
• Sites: 2

Brief Summary

Annually influenza is a leading cause of severe disease and mortality particularly in young children \<5 years old and pregnant women in the low and middle-income countries (LMICs) and both groups are prioritised for vaccination by the World Health Organisation (WHO). In Bangladesh, influenza is responsible for 10% of all childhood pneumonias and 9% of all death. Maternal influenza is associated with an increased risk of hospitalisation and foetal malformation. Influenza is a vaccine preventable disease, however, in most LMICs influenza vaccination is not part of the vaccination programme. This study will evaluate the effectiveness of inactivated influenza vaccine against influenza illness among pregnant women and children in Bangladesh. Influenza vaccine has not yet been studied as combined immunization strategy in a cluster randomized trial. This study is a community-based randomised trial in both pregnant women and young children to assess the impact of inactivated influenza vaccine in preventing influenza in the community as well as population level impact by both direct and indirect effect of vaccination.

Conditions

Influenza Viral Infections

Keywords

influenza; vaccine; safety; immunogenicity; effectiveness

Outcome Measures

Primary Outcomes (1)

• Effectiveness of influenza vaccination in reducing rates of acute respiratory infections due to laboratory-confirmed influenza in pregnant women at 28 to 34 weeks of gestation period and children 6 to 59 months old

  The direct effectiveness of influenza vaccine in reducing rates of acute influenza infections in vaccinated patients attending a treatment facility will be assessed. The indirect effectiveness will be calculated by comparing the rates of influenza in the villages where influenza vaccine is introduced to the influenza rates in people from villages vaccinated with the control vaccine.

  through study completion, an average of 3 year

Secondary Outcomes (4)

• Safety of influenza vaccine among pregnant women at 28 to 34 weeks of gestation period and children 6 to 59 months old in Bangladesh

  through study completion, an average of 1.5 year

• Surveillance for influenza and other respiratory viruses

  through study completion, an average of 3 year

• Vaccine immunogenicity in pregnant women and children

  through study completion, an average of 3 year

• Indirect vaccine effectiveness of influenza vaccination of pregnant women and children

  through study completion, an average of 3 year

Study Arms (2)

Inactivated influenza vaccine group

EXPERIMENTAL

Vaccines will be administered as a single dose regimen for the pregnant women and two doses for children at 28-day interval as recommended by the vaccine manufacturers.

Biological: Inactivated influenza vaccine

Inactivated polio vaccine group

ACTIVE COMPARATOR

Vaccines will be administered as a single dose regimen for the pregnant women and two doses for children at 28-day interval as recommended by the vaccine manufacturers.

Biological: Inactivated polio vaccine

Interventions

Inactivated influenza vaccine BIOLOGICAL

Vaccines will be administered as a single dose regimen for the pregnant women and two doses for children at 28-day interval as recommended by the vaccine manufacturers.

Inactivated influenza vaccine group

Inactivated polio vaccine BIOLOGICAL

Vaccines will be administered as a single dose regimen for the pregnant women and two doses for children at 28-day interval as recommended by the vaccine manufacturers.

Inactivated polio vaccine group

Eligibility Criteria

• Age: 6 Months - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Permanent Resident in selected villages in Matlab HDSS MCH-FP area
• Age 18 - 49 years old
• to 34 weeks of gestation at the time of enrollment
• Willing to stay in the study village for the next 20 months

You may not qualify if:

• Refusal to provide consent for participation
• Unable to participate in the full length of the study period
• Known allergy to egg or any product of vaccine
• Sick (has documented fever and respiratory illness) at the time of enrollment
• Pregnancy with complications such as chronic pulmonary (including asthma), cardiovascular, renal, hepatic, hematologic (including sickle cell disease), or metabolic disorders (including diabetes mellitus and obesity) or neurologic and neurodevelopment conditions, cancer, immunosuppression, and, multiple pregnancy)
• Received any vaccine /immune component in last 2 weeks
• Participated in any research study in the last 3 months
• Permanent Resident in selected villages in Matlab HDSS MCH-FP area
• Age 6 to 59 months old
• Parents/guardians confirm their willingness to stay in the study village for the next 20 months
• Parents refuse to provide consent for participation
• Unable to participate in the full length of the study period
• Known allergy to egg or any product of vaccine
• Sick children (has documented fever and respiratory illness) at the time of enrolment
• Chronic illness such as chronic pulmonary (including asthma), cardiovascular, renal, hepatic, hematologic (including sickle cell disease), or metabolic disorders (including diabetes mellitus and obesity) or neurologic and neurodevelopment conditions, cancer, and immunosuppression

Sponsors & Collaborators

• University of Bergen: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (2)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Links

• icddr, b is an international health research organisation located in Dhaka, Bangladesh
• The Influenza Centre is a collaboration between the University of Bergen, The Haukeland University Hospital and the Department of Health.

MeSH Terms

Conditions

Influenza, Human

Interventions

Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Rebecca Cox, PhD

  University of Bergen, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Rebecca Cox

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: August 10, 2021
• Study Start: April 7, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1); NO (1)