Overview
Sponsor-declared trial summary
Whooping cough
The main objective of the project is to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunized during pregnancy. Specifically, the project aims to identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal ant…
Key facts
- Sponsor
- Universite Libre de Bruxelles
- Participant type
- Pediatric, Healthy volunteers
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 9 Sep 2023 → 23 Dec 2025
- Decision date (initial)
- 2024-10-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- National Institutes of Health (USA)
External identifiers
- EU CT number
- 2024-517893-73-00
- EudraCT number
- 2022-002697-80
- ClinicalTrials.gov
- NCT05856396
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response
The main objective of the project is to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunized during pregnancy. Specifically, the project aims to identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in infants.
Conditions and MedDRA coding
Whooping cough
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10047976 | Whooping cough due to bordetella pertussis (B. pertussis) | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- (Women) Age between 18 and 45 years
- (Women) Eligible for Tdap vaccination
- (Women) Last Pertussis vaccination > 12 months ago
- (Women) Pregnant and non-pregnant women
- (Infants) Infants of 2 months (+- 1 week) of age (boys and girls)
- (Infants) Born after 35 weeks of gestation
- (Infants) Birthweight above 2.5 kg
- (Infants) Consent form signed by the parents
Exclusion criteria 11
- (Women) Inability to understand the nature and extent of the study and the procedures required
- (Women) Grade III/IV anemia
- (Women) Acute infection at the time of immunization
- (Women) Chronic infections such as HBV, HCV or HIV infection, acute toxoplasmosis
- (Women) Current or recent use of immunosuppressive drugs
- (Women) Active neoplasia
- (Women) Other vaccination at the same time as pertussis vaccination (wash out of 4 weeks after other vaccinations and 28 days after Tdap vaccination)
- (Pregnant women) Risk of premature delivery or intrauterine growth retardation
- (Pregnant women) Twin or triplet pregnancies
- (Infants) Severe neonatal distress
- (Infants) Serious congenital abnormalities or congenital infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The magnitude of the antibody responses to pertussis vaccination
Secondary endpoints 4
- Subclass and binding of pertussis-specific antibodies to Fc-receptors, complement and lectin-like receptors post vaccination.
- Functional antibody profiling post vaccination (including assays covering cytotoxicity, phagocytosis, cytokine production, antigen uptake)
- Antibody and B cell repertoire post vaccination
- The magnitude and quality of Tdap-specific T lymphocytes post vaccination
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD4500245 · Product
- Active substance
- Diphtheria Toxoid
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
- Marketing authorisation
- BE502222
- MA holder
- SANOFI PASTEUR EUROPE
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9016895 · Product
- Active substance
- Haemophilus Influenzae Type B Polyribosylribitol Phosphate Conjugated to Meningococcal Protein Adsorbed on Amorphous Aluminium Hydroxyphosphate Sulfate
- Pharmaceutical form
- SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1.5 ml millilitre(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07CA09 — DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS-HEPATITIS B
- Marketing authorisation
- EU/1/15/1079/004
- MA holder
- MCMVACCAFF
- MA country
- EU
- Paediatric formulation
- Yes
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universite Libre de Bruxelles
- Sponsor organisation
- Universite Libre de Bruxelles
- Address
- Rue Adrienne Bolland 8
- City
- Charleroi
- Postcode
- 6041
- Country
- Belgium
Scientific contact point
- Organisation
- Universite Libre de Bruxelles
- Contact name
- Arnaud Marchant
Public contact point
- Organisation
- Universite Libre de Bruxelles
- Contact name
- Arnaud Marchant
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 240 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-09-09 | 2025-12-23 | 2023-09-12 | 2025-12-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| MADI-02_Summary of results SUM-136976
|
2026-06-02T10:57:48 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| MADI-02_Lay person summary of results | 2026-06-02T10:58:39 | Submitted | Laypersons Summary of Results |
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | MADI-02_Lay person summary of results_20260529 | 1 |
| Protocol (for publication) | D1_Protocol 2022-002697-80_redacted | 3.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infants | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infants_FR | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infants_NL | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant and non pregnant women | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant and non pregnant women_FR | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant and non pregnant women_NL | 4.0 |
| Subject information and informed consent form (for publication) | L2_informed consent procedure CHU SAINT PIERRE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Triaxis | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vaxelis | 1 |
| Summary of results (for publication) | MADI-02_Summary of results_20260529 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-25 | Belgium | Acceptable 2024-10-16
|
2024-10-16 |