Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04998344 |
Other study ID # |
PR-19103 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
April 7, 2021 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
April 2024 |
Source |
University of Bergen |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
This clinical trial will be conducted in rural Matlab, Bangladesh, covered by a Maternal,
Child Health and Family Planning intervention program (named MCH-FP area). Twenty villages in
the Maternal, Child Health and Family Planning intervention program area will be randomized
at a 1:1 ratio to receive either inactivated influenza vaccine (IIV) or the control
inactivated polio vaccine (IPV). Recruitment, randomization and vaccination of healthy
pregnant women at 28 to 34 weeks of gestation period and children 6 to 59 months old at the
time of enrolment will be carried out from fixed site clinics working in the MCH-FP area.
Vaccines will be administered as a single dose regimen for the pregnant women and two doses
for children at 28-days interval as recommended by the vaccine manufacturers. All pregnant
women in the third trimester of pregnancy (n~300), and children 6 to 59 months old in 20
villages in the MCH-FP area of Matlab will be eligible for vaccination (n~3500) for the
study. In addition, all residents of study villages will be included in the influenza
surveillance.
All vaccinated pregnant women and parents of vaccinated children 6 to 59 months old will be
asked to inform the study team by phone of any respiratory illnesses or to visit the Matlab
hospital. Also, all residents of the study villages will be asked to visit the Matlab
hospital/fixed site clinic for any respiratory illness. Participants will receive regular SMS
messages to remind them to report cases of influenza like illness (ILI). At the hospital, the
medical officer will examine the sick patient and decide if the criteria of the ILI case
definition are met. ILI is defined as an acute respiratory infection with: measured fever of
≥ 38 C° and cough; with onset within the last 10 days for adults; and in case of children as
measured axillary temperature ≥ 38.0°C with onset within the last 10 days and at least one of
the following symptoms: cough, sore throat, nasal congestion, rhinorrhea, earache or ear
discharge. In medically confirmed ILI cases, the trial will collect nasopharyngeal and throat
swabs for confirmation of the aetiology of the infection, as well as collect serum samples
from vaccinated participants Passive surveillance will continue for 18 months following
completion of vaccination.
Outcome measures/variables:
1. Incidence, prevalence, seasonality and clinical descriptions of :
1. Influenza infection including clinical pneumonia in child (fever, cough and
respiratory difficulties)
2. Influenza infection including clinical pneumonia in mother (fever, cough and
respiratory difficulties)
2. HAI antibody titres to calculate the rate of reduction of risk of influenza infection or
disease in influenza vaccination pregnant women and children as well as reduction of flu
infection in population of intervention and control villages
3. Evaluation of simple sample collection methods in children to assess Influenza specific
antibody responses in DBS and saliva sample
4. Clinical and demographic risk factors associated with illness
5. Comparisons of pregnancy outcomes and post-delivery illness/complication
6. Clinical and laboratory confirmation of influenza and other respiratory virus in sick
individuals
7. Economic evaluation of influenza vaccination in pregnant women and children