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

NCT04998344 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3800

Last updated 2024-04-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

Inactivated influenza vaccine

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

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.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Norwegian University of Science and Technology

    collaborator OTHER

  • University of Bergen

    lead OTHER

Principal Investigators

  • Rebecca Cox, PhD · University of Bergen, Norway

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Bangladesh
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04998344 on ClinicalTrials.gov