Clinical trial • Phase IV • Infectious Disease

RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN WI-38 HUMAN DIPLOID LUNG FIBROBLASTS; MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS; MEASLES VIRUS EDMONSTON-ENDERS STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS for Measles | Mumps | Rubella

Phase IV trial of RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN WI-38 HUMAN DIPLOID LUNG FIBROBLASTS; MUMPS VIRUS JERYL LYNN (LEVEL B…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Measles | Mumps | Rubella
Trial Stage
Phase IV
Drug Modality
Vaccine
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
04-02-2026
First CTIS Authorization Date
14-04-2026

Trial design

Randomised, unvaccinated lactating women (no mmr vaccine) as comparator; intervention: m-m-rvaxpro powder and solvent for suspension for injection (measles, mumps and rubella vaccine (live)), intramuscular injection, product information lists 0.5 ml (dose unit) and route intramuscular injection. no additional schedule details provided in the available data.-controlled Phase IV trial across 1 site in Belgium.

Randomised
Yes
Comparator
Unvaccinated lactating women (no MMR vaccine) as comparator; intervention: M-M-RvaxPro powder and solvent for suspension for injection (Measles, mumps and rubella vaccine (live)), intramuscular injection, product information lists 0.5 ml (dose unit) and route intramuscular injection. No additional schedule details provided in the available data.
Target Sample Size
120
Trial Duration For Participant
90

Eligibility

Recruits 120 paediatric patients.

Pregnancy Exclusion
Acute infection at the time of delivery or in the last 7 days of pregnancy
Vulnerable Population
Infants are included as a vulnerable population. Separate subject information sheets and informed consent forms are available for adults and infants (L1_SIS and ICF_Adults; L1_SIS and ICF_Infants). Mothers (adult participants) must be capable of giving consent for themselves; parental consent is required for infant participants. Assent procedures for older children are not specified.

Inclusion criteria

  • {"criterion_text":"- Age between 18 and 45 years, healthy\n- Intention to breastfeed for more than 2 months\n- Capable of giving consent for themselves"}

Exclusion criteria

  • {"criterion_text":"- Inability to understand the nature and extent of the study and the procedures required\n- Blood hemorrhage >500 mL during delivery\n- Acute infection at the time of delivery or in the last 7 days of pregnancy\n- Grade III/IV anaemia\n- Chronic infections such as HBV , HCV or HIV infection; acute toxoplasmosis\n- Current or recent use of immunosuppressive drugs\n- Active neoplasia\n- Twin or triplet pregnancies\n- Infants born before 35 weeks of gestation\n- Infant birthweight below 2.5 kg\n- Infant serious congenital abnormalities or congenital infection"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The level of binding antibodies against measles in breastmilk in vaccinated vs unvaccinated mothers, 5 times over 3 months.","definition_or_measurement_approach":"Measurement of levels of binding antibodies against measles in breastmilk samples collected five times over a 3-month period to compare vaccinated versus unvaccinated lactating mothers."}

Secondary endpoints

  • {"endpoint_text":"- Phenotype and activation of immune cells in breastmilk","definition_or_measurement_approach":"Assessment of immune cell phenotype and activation status in breastmilk samples (methodology not specified in provided data)."}

Recruitment

Planned Sample Size
120
Recruitment Window Months
41
Consent Approach
Informed consent obtained from adult participants (mothers) who must be capable of giving consent for themselves. Parental consent is obtained for infant participants. Separate subject information sheets and informed consent forms are available for adults and for infants (L1_SIS and ICF_Adults; L1_SIS and ICF_Infants). Specific languages of consent documents are not explicitly listed in the provided data.

Methods

  • Use of recruitment materials/flyers targeted to mothers and infants (documents present: 'MEALAC_Flyer Mothers_V1' and 'MEALAC_Flyer Infants_V1') - channel: printed/distribution materials directed at lactating women and parents; country: Belgium.
  • Recruitment arrangements documented ('K1_Recruitment arrangements' document present) - indicates organized recruitment procedures (specific channels and approaches not extractable from provided files).

Geography

Total Number Of Sites
1
Total Number Of Participants
120

Belgium

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
19
Number Of Sites
1
Number Of Participants
120

Sites

Site Name
CHU Saint Pierre
Department Name
Pediatrics
Contact Person Name
Tessa Goetghebuer
Number Of Participants
120

Sponsor

Primary sponsor

Full Name
Universite Libre de Bruxelles
Organisation Type
Educational Institution
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
M-M-RvaxPro powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live)
Active Substance
RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN WI-38 HUMAN DIPLOID LUNG FIBROBLASTS; MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS; MEASLES VIRUS EDMONSTON-ENDERS STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS
Modality
Vaccine
Routes Of Administration
Intramuscular injection
Route
Intramuscular injection
Authorisation Status
Marketing authorisation (EU/1/06/337/001)
Starting Dose
0.5 ml
Dose Levels
0.5 ml
Maximum Dose
1 ml

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