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An Effectiveness Trial to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh
Sponsor: University of Bergen
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.
Official title: An Effectiveness Trial (Phase IV) to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh
Key Details
Gender
All
Age Range
6 Months - 49 Years
Study Type
INTERVENTIONAL
Enrollment
3800
Start Date
2021-04-07
Completion Date
2024-12-31
Last Updated
2024-04-19
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (2)
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
Norwegian University of Science and Technology
Trondheim, Norway