Influenza Viral InfectionsPhase 4FluEffectNCT04998344
An Effectiveness Trial to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh
A Phase 4 study testing Inactivated influenza vaccine and Inactivated polio vaccine in people with Influenza Viral Infections, run by University of Bergen at 2 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 6 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Viral Infections
- What is being tested?
- Inactivated influenza vaccine and Inactivated polio vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,800 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Apr 2021to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Permanent Resident in selected villages in Matlab HDSS MCH-FP area
- Age 18 - 49 years old
- 28 to 34 weeks of gestation at the time of enrollment
- Willing to stay in the study village for the next 20 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
Who cannot join
- 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
Show all 14Show fewer
- Participated in any research study in the last 3 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
- Received any vaccine /immune component in last 4 weeks
- Participated in any research study in the last 3 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Official title: An Effectiveness Trial (Phase IV) to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh
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.
Read the detailed 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:
- Incidence, prevalence, seasonality and clinical descriptions of :
- Influenza infection including clinical pneumonia in child (fever, cough and respiratory difficulties)
- Influenza infection including clinical pneumonia in mother (fever, cough and respiratory difficulties)
- 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
- Evaluation of simple sample collection methods in children to assess Influenza specific antibody responses in DBS and saliva sample
- Clinical and demographic risk factors associated with illness
- Comparisons of pregnancy outcomes and post-delivery illness/complication
- Clinical and laboratory confirmation of influenza and other respiratory virus in sick individuals
- Economic evaluation of influenza vaccination in pregnant women and children
- Conditions
- Influenza Viral Infections
- Being tested
- Inactivated influenza vaccine, Inactivated polio vaccine
- Keywords
- influenza, vaccine, safety, immunogenicity, effectiveness
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated influenza vaccineBiological
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 vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Inactivated polio vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The safety of the vaccine will be monitored through a field visit on Day 3 after each dose of vaccination and thereafter by telephone. All adverse events will be recorded, and any serious adverse events will be investigated. Adverse events after vaccination will be summarized and compared between the intervention and control groups.
Measured: through study completion, an average of 1.5 year
Surveillance for influenza and other respiratory viruses
In medically confirmed ILI cases, nasopharyngeal and throat swabs will be collected for laboratory confirmation of the aetiology of the infection, Passive surveillance will continue for 18 months following completion of vaccination.
Measured: through study completion, an average of 3 year
Vaccine immunogenicity in pregnant women and children
The hemagglutination inhibition assay will be used to assess the vaccine immunogenicity to the homologous vaccine strains and appropriate epidemic strains.
Measured: through study completion, an average of 3 year
Indirect vaccine effectiveness of influenza vaccination of pregnant women and children
All residents of the 20 study villages will be included in the influenza surveillance. Influenza cases will be defined as laboratory confirmed rRT-PCR influenza A and/or B viruses during the influenza surveillance period. The total and indirect vaccine protection in the population will be assessed from medical records for birth outcomes, birth weights, ILI, hospitalization and death records in Matlab.
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start7 Apr 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Viral InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Norwegian University of Science and Technology
- Responsible party
- Principal investigator, Rebecca Cox, University of Bergen
- Investigators
- Rebecca Cox, PhD, Principal investigator, University of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998344
- Sponsor's protocol ID
- PR-19103
- Acronym
- FluEffect
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effectiveness Trial (Phase IV) to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT04998344
- Acronym / sponsor ID
- FluEffect / PR-19103
- Conditions
- Influenza Viral Infections
- Keywords
- influenza, vaccine, safety, immunogenicity, effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,800 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Norwegian University of Science and Technology
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Incidence, prevalence, seasonality and clinical descriptions of :
- Influenza infection including clinical pneumonia in child (fever, cough and respiratory difficulties)
- Influenza infection including clinical pneumonia in mother (fever, cough and respiratory difficulties)
- 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
- Evaluation of simple sample collection methods in children to assess Influenza specific antibody responses in DBS and saliva sample
- Clinical and demographic risk factors associated with illness
- Comparisons of pregnancy outcomes and post-delivery illness/complication
- Clinical and laboratory confirmation of influenza and other respiratory virus in sick individuals
- Economic evaluation of influenza vaccination in pregnant women and children
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactivated influenza vaccine group | Experimental | Biological: Inactivated influenza vaccineVaccines 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 | Active comparator | Biological: Inactivated polio vaccineVaccines 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. |
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Permanent Resident in selected villages in Matlab HDSS MCH-FP area
- Age 18 - 49 years old
- 28 to 34 weeks of gestation at the time of enrollment
- Willing to stay in the study village for the next 20 months
- Permanent Resident in selected villages in Matlab HDSS MCH-FP area
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactivated influenza vaccineVaccines 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 group |
| Inactivated polio vaccineVaccines 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 group |
Primary outcome
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
Time frame: through study completion, an average of 3 year
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.
4 secondary outcomes
Safety of influenza vaccine among pregnant women at 28 to 34 weeks of gestation period and children 6 to 59 months old in Bangladesh
Time frame: through study completion, an average of 1.5 year
Surveillance for influenza and other respiratory viruses
Time frame: through study completion, an average of 3 year
Vaccine immunogenicity in pregnant women and children
Time frame: through study completion, an average of 3 year
Indirect vaccine effectiveness of influenza vaccination of pregnant women and children
Time frame: through study completion, an average of 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- icddr, b is an international health research organisation located in Dhaka, BangladeshLink provided by the sponsor.
- The Influenza Centre is a collaboration between the University of Bergen, The Haukeland University Hospital and the Department of Health.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Cox, PhD principal investigator
University of Bergen, Norway
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inactivated influenza vaccine and Inactivated polio vaccine in people with Influenza Viral Infections, run by University of Bergen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.