Vaccination; InfectionPhase 4MADI-01NCT06716567
Maternal Determinants of Immunity to Influenza
A Phase 4 study testing Influenza vaccine in people with Vaccination; Infection and Maternal-Fetal Relations, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccination; Infection, Maternal-Fetal Relations, Influenza
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Nov 2020to 10 Nov 2023
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age over 18 and under 40 years.
Who cannot join
- Grade III/IV anemia
- Human Immunodeficiency Virus (HIV) infection
- Active bacterial infection
- Opportunistic infection (Tuberculosis, cytomegalovirus (CMV), toxoplasmosis, etc)
- Inability to understand the nature and extent of the study and the procedures required
- Current or recent use of immunosuppressive drugs (corticosteroids, anti-tumor necrosis factors (anti-TNF), methotrexate, etc)
- Active neoplasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Determinants of Immunity to Influenza (MADI-01)
The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.
Read the detailed description
The study compares immune responses to influenza vaccination between a group of pregnant women and a group of non-pregnant controls women. Specifically, the study has three aims:
- To compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women;
- To identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women;
- To identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;
- Being tested
- Influenza vaccine
- Medical subject headings
- Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
Alpharix-Tetra®, Vaxigrip Tetra® and Influvac Tetra® were used as influenza vaccines in the 2020-2021, 2021-2022, and 2022-2023 seasons respectively.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Active comparator | Pregnant women receive one dose of influenza-containing vaccine during pregnancy. Receives: Biological: Influenza vaccine |
| Non-pregnant women | Active comparator | Non-pregnant women receive one dose of influenza-containing vaccine. Receives: Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemagglutination Inhibition Assay titre
Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of >=40 is considered protective in adults.
HAI titres will be measured in :
- Pregnant women
- Non-pregnant women
Measured: 28 days post vaccination
Haemagglutination Inhibition Assay titre
Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of >=40 is considered protective in adults.
HAI titres will be measured in :
- Pregnant women
- In umbilical cord blood
Measured: At delivery
Secondary outcomes (4)
Haemagglutination inhibition assay titre
Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of >=40 is considered protective in adults.
HAI titres will be measured in :
- Pregnant women: at day of vaccination, day 7 post-vaccination, day 28 post-vaccination, at delivery, week 6 and 12 post-delivery
- Non-pregnant women: at day of vaccination, day 7, day 28, and Month 6 post-vaccination
Measured: up to 11 months after vaccination
Micro neutralization assay titre
Micro neutralization assay (MNA) titres are measured on serum samples with detectable HAI titres to determine cross reactivity to related virus strains. This method assesses the ability of serum antibodies to prevent virus from infecting a single layer of cells in a micro titre plate.
MNA titres will be measured in :
- Pregnant women: at day of vaccination, day 7 post-vaccination, day 28 post-vaccination, at delivery, week 6 and 12 post-delivery
- Non-pregnant women: at day of vaccination, day 7, day 28, and Month 6 post-vaccination
Measured: up to 11 months after vaccination
Influenza virus specific IgG titre
IgG titres specific to influenza virus Hemagglutinin (HA) and Neuraminidase (NA) are measured using conventional Enzyme-linked immunosorbent assay (ELISA) methods. The Enzyme-Linked Lectin Assay (ELLA) is used for detection of NA-specific antibodies only, using reverse genetics viruses with irrelevant HA to ensure only NA antibodies are measured. ELLA is an ELISA variant but adapted to measure the concentration of antibody to NA, determining the amount of sialic acid cleaved from fetuin.
IgG titres specific to Influenza Antigens will be assessed by ELISA and ELLA in:
- Pregnant women: at day of vaccination, day 7 post-vaccination, day 28 post-vaccination, at delivery, week 6 and 12 post-delivery
- Non-pregnant women: at day of vaccination, day 7, day 28, and Month 6 post-vaccination
Measured: up to 11 month after vaccination
Influenza virus specific IgG antibody avidity
IgG avidity will be measured using chaotropic salts.
IgG avidity will be assessed in :
- Pregnant women: at day of vaccination, day 7 post-vaccination, day 28 post-vaccination, at delivery, week 6 and 12 post-delivery
- Non-pregnant women: at day of vaccination, day 7, day 28, and Month 6 post-vaccination
Measured: up to 11 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start16 Nov 2020
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination; InfectionStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pregnant women and non-pregnant women are recruited in parallel.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Responsible party
- Principal investigator, Nicolas Dauby, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716567
- Sponsor's protocol ID
- B762020201013
- Acronym
- MADI-01
- Status last verified
- Mar 2025
- First submitted
- 29 Nov 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Determinants of Immunity to Influenza (MADI-01)
- ClinicalTrials.gov ID
- NCT06716567
- Acronym / sponsor ID
- MADI-01 / B762020201013
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 4 Dec 2024 (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.
The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.
Detailed description
The study compares immune responses to influenza vaccination between a group of pregnant women and a group of non-pregnant controls women. Specifically, the study has three aims:
- To compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women;
- To identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women;
- To identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pregnant women and non-pregnant women are recruited in parallel.
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Active comparator | Biological: Influenza vaccinePregnant women receive one dose of influenza-containing vaccine during pregnancy. |
| Non-pregnant women | Active comparator | Biological: Influenza vaccineNon-pregnant women receive one dose of influenza-containing vaccine. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age over 18 and under 40 years.
Key exclusion criteria (7 listed)
- Grade III/IV anemia
- Human Immunodeficiency Virus (HIV) infection
- Active bacterial infection
- Opportunistic infection (Tuberculosis, cytomegalovirus (CMV), toxoplasmosis, etc)
- Inability to understand the nature and extent of the study and the procedures required
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 |
|---|---|---|
| Influenza vaccineAlpharix-Tetra®, Vaxigrip Tetra® and Influvac Tetra® were used as influenza vaccines in the 2020-2021, 2021-2022, and 2022-2023 seasons respectively. | Biological | Non-pregnant women, Pregnant women |
Primary outcome
Haemagglutination Inhibition Assay titre
Time frame: 28 days post vaccination
Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of >=40 is considered protective in adults. HAI titres will be measured in : * Pregnant women * Non-pregnant women
Haemagglutination Inhibition Assay titre
Time frame: At delivery
Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of >=40 is considered protective in adults. HAI titres will be measured in : * Pregnant women * In umbilical cord blood
4 secondary outcomes
Haemagglutination inhibition assay titre
Time frame: up to 11 months after vaccination
Micro neutralization assay titre
Time frame: up to 11 months after vaccination
Influenza virus specific IgG titre
Time frame: up to 11 month after vaccination
Influenza virus specific IgG antibody avidity
Time frame: up to 11 months after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza vaccine in people with Vaccination; Infection and Maternal-Fetal Relations, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Haemagglutination Inhibition Assay titre (time frame: 28 days post vaccination). The study lists 2 primary outcomes in all. 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 24 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.