Overview
Sponsor-declared trial summary
Measles
The main objective of this study is to investigate the humoral immune response to MMR vaccination in breastmilk over a 3-month period. This will allow us to determine to which extent a booster MMR dose during lactation can induce more antibodies against measles, as compared to unvaccinated lactating women, and to study…
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] - Virus Diseases [C02]
- Decision date (initial)
- 2026-04-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Fonds de la recherche scientifique
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response
The main objective of this study is to investigate the humoral immune response to MMR vaccination in breastmilk over a 3-month period. This will allow us to determine to which extent a booster MMR dose during lactation can induce more antibodies against measles, as compared to unvaccinated lactating women, and to study the waning of this response over time.
Secondary objectives 1
- To assess the phenotype and activation of immune cells in breastmilk in response to MMR vaccination.
Conditions and MedDRA coding
Measles
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10069547 | Mumps immunization | 10042613 |
| 21.1 | LLT | 10069545 | Measles immunization | 10042613 |
| 21.1 | LLT | 10069564 | Rubella immunization | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age between 18 and 45 years, healthy
- Intention to breastfeed for more than 2 months
- Capable of giving consent for themselves
Exclusion criteria 11
- Inability to understand the nature and extent of the study and the procedures required
- Grade III/IV anaemia
- Chronic infections such as HBV , HCV or HIV infection; acute toxoplasmosis
- Current or recent use of immunosuppressive drugs
- Active neoplasia
- Twin or triplet pregnancies
- Infants born before 35 weeks of gestation
- Infant birthweight below 2.5 kg
- Infant serious congenital abnormalities or congenital infection
- Blood hemorrhage >500 mL during delivery
- Acute infection at the time of delivery or in the last 7 days of pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The level of binding antibodies against measles in breastmilk in vaccinated vs unvaccinated mothers, 5 times over 3 months.
Secondary endpoints 1
- Phenotype and activation of immune cells in breastmilk
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD4577956 · Product
- Active substance
- Rubella Virus Wistar Ra 27/3 Strain (Live, Attenuated) Produced in WI-38 Human Diploid Lung Fibroblasts
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07BD52 — MORBILLI, COMBINATIONS WITH PAROTITIS AND RUBELLA, LIVE ATTENUATED
- Marketing authorisation
- EU/1/06/337/001
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- 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
- Lennikse Baan 808
- City
- Anderlecht
- Postcode
- 1070
- 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 | Authorised, recruitment pending | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_MEALAC_Protocol_V1_redacted_2025-524862-12 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | MEALAC_Flyer Infants_V1 | 1 |
| Recruitment arrangements (for publication) | MEALAC_Flyer Mothers_V1 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adults | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adults | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adults | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infants | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infants | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infants | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC M-M-RVAXPRO | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis 2025-524862-12_DE | 2 |
| Synopsis of the protocol (for publication) | D1_Synopsis 2025-524862-12_EN | 2 |
| Synopsis of the protocol (for publication) | D1_Synopsis 2025-524862-12_FR | 2 |
| Synopsis of the protocol (for publication) | D1_Synopsis 2025-524862-12_NL | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-04 | Belgium | Acceptable 2026-04-14
|
2026-04-14 |