A Phase 4 interventional study of Combined measles-mumps-rubella (MMR) vaccine - PRIORIX® in Measles, Rubella and Mumps, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 36 Years. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Prevention
In order to assess the safety of breastfed infants after their mother's postpartum immunization with a combined measles-mumps-rubella (MMR) vaccine, the purpose of this study is to investigate whether measles vaccine strain is excreted in breast milk of breastfeeding women with negative rubella and measles serologies.
This is a multicentre prospective study, to evaluate the safety of infant from 50 breastfeeding women, analyzable for primary endpoint, after postpartum immunization with MMR vaccine.
During the screening period, eligibility will be determined based on the inclusion and exclusion criteria. Medical records of pregnant women will be screened by study investigators, who will then propose to the woman to participate to the study during a phone call or a follow-up visit. Screening visit could take place 4 months before delivery planned date up until the day of delivery.
The investigator will explain the study to the woman. A copy of the informed consent documents will be given to the woman for reading and for further information about the study (by email, by post, or personally).
If the woman is willing to participate to the study and after she had given her screening informed consent, a blood sample for measles serological analysis will be drawn.
After signing the consent, women meeting all the inclusion criteria and none of the exclusion criteria will be vaccinated in post partum and before the exit of the maternity at day 0.
Each woman will have a blood draw at day 0 and breast milk samples as well as urine samples at the hospital at day 0 before vaccination.
Each included woman will also provide breast milk and urine home samples at days 7, 11 and 14 after vaccination. Reminder calls will be performed at days 7, 11 and 14 after vaccination.
Women will then be followed and vaccinated 8 weeks after the first vaccination, visit V1.
Each infant will be followed during 8 weeks. An optional blood sample for immunological analysis will be drawn at week 8 (visit v1). Informed consent form signed by the person(s) holding parental authority (both parents or mother only if the father has no parental authority) is needed for the infant to be included as well.
Diary cards will be used to follow the infant and the mother. If Infant and/or mother develop(s) suspected measles symptom(s), they will be evaluated by a study physician as soon as possible, preferably within 24 to 72 hours of acute measles symptom(s) onset.
In case of mother symptoms, infant will be also seen by a physician during mother's supplementary visit.
The visit at day 0 (V0) of the study will be performed at the maternity. The other visits, screening visit, V1 and supplementary visit (SV), will be performed either at the maternity or at the corresponding CIC if applicable. Home samples at 7, 11 and 14 days after vaccination will be directly sent at the laboratory of virology at Limoges. Home sampling can also be performed at the maternity or CIC according to their internal organization.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 14 is below the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women:
Infants:
Exclusion Criteria:
Women:
Woman with for MMR vaccination:
Infants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
70 breastfeeding women meeting all the inclusion criteria and none of the exclusion criteria will be immunized with MMR vaccine in postpartum (before the exit of the maternity)
Biological: Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®
One dose of 0.5 mL vaccine will be administered (intra-muscularly or subcutaneous) in post-partum (before the exit of the maternity) during visit V0. A second dose will be administered at week 8(+/-15 days) during visit V1.
Prevalence of the measles vaccine virus strain in breast milk.
Number of women with positive RT-PCR for measles vaccine virus strain in breast milk for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
Time frame: day 7 after the first vaccination.
Prevalence of the measles vaccine virus strain in breast milk.
Number of women with positive RT-PCR for measles vaccine virus strain in breast milk for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
Time frame: day 11 after the first vaccination.
Prevalence of the measles vaccine virus strain in breast milk.
Number of women with positive RT-PCR for measles vaccine virus strain in breast milk for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
Time frame: day 14 after the first vaccination.
Number of infants with reported clinical symptoms of measles
Evaluation of the clinical impact of MMR vaccination in breastfeeding infant
Time frame: At V1 Visit (8 weeks +/- 15 days)
Number of infants with reported clinical symptoms of measles
Evaluation of the clinical impact of MMR vaccination in breastfeeding infant from data reported in the infant diary card (DiCa).
Time frame: Between V0 visit and V1 visit (8 weeks +/- 15 days) after the first MMR vaccination
Number of women with reported clinical symptoms of measles
Evaluation of the clinical impact of MMR vaccination in breastfeeding infant from mother clinical data
Time frame: V1 Visit (8 weeks +/- 15 days) after the first MMR vaccination
Number of women with reported clinical symptoms of measles
Evaluation of the clinical impact of MMR vaccination in breastfeeding infant from mother clinical data repoted in the diary card (DiCa).
Time frame: Between V0 visit and V1 visit (8 weeks +/- 15 days) after the first MMR vaccination
Number of infants with positive measles serology (IgM)
Evaluation of the immunological impact of MMR vaccination in breastfeeding infant.
Time frame: V1 visit (8 weeks +/- 15 days) after the first MMR vaccination
Number of women with positive RT-PCR for measles vaccine virus strain in urine in at least one sample
For detection of measles vaccine strain excretion in urine of breastfeeding women, the number of women, with negative rubella and measles serologies with positive RT-PCR for measles vaccine virus strain in urine for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine will be assessed. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
Time frame: At day 7 after the first vaccination.
Number of women with positive RT-PCR for measles vaccine virus strain in urine in at least one sample
For detection of measles vaccine strain excretion in urine of breastfeeding women, the number of women, with negative rubella and measles serologies with positive RT-PCR for measles vaccine virus strain in urine for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine will be assessed. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
Time frame: At day 11 after the first vaccination.
Number of women with positive RT-PCR for measles vaccine virus strain in urine in at least one sample
For detection of measles vaccine strain excretion in urine of breastfeeding women, the number of women, with negative rubella and measles serologies with positive RT-PCR for measles vaccine virus strain in urine for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine will be assessed. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
Time frame: At day 14 after the first vaccination.
Quantification of the measles vaccine virus strain presented in breast milk in at least one sample
In case of detection of measles vaccine virus strain excretion in breast milk, RT-PCR quantification measure of measles vaccine virus strain in woman breastmilk will be performed.
Time frame: At day 7 after the first vaccination.
Quantification of the measles vaccine virus strain presented in breast milk in at least one sample
In case of detection of measles vaccine virus strain excretion in breast milk, RT-PCR quantification measure of measles vaccine virus strain in woman breastmilk will be performed.
Time frame: At day 11 after the first vaccination.
Quantification of the measles vaccine virus strain presented in breast milk in at least one sample
In case of detection of measles vaccine virus strain excretion in breast milk, RT-PCR quantification measure of measles vaccine virus strain in woman breastmilk will be performed.
Time frame: At day 14 after the first vaccination.
Microscopy assessment of the infectious activity of the measles vaccine virus presented in breast milk in at least one sample.
In case of detection of measles vaccine virus strain excretion in breast milk. The evaluation of the infectious activity of the measles vaccine virus will be performed using an in vitro infectivity assay. A result will be considered as positive when at least one positive fluorescent cell is detected.
Time frame: At day 7
Microscopy assessment of the infectious activity of the measles vaccine virus presented in breast milk in at least one sample.
In case of detection of measles vaccine virus strain excretion in breast milk. The evaluation of the infectious activity of the measles vaccine virus will be performed using an in vitro infectivity assay. A result will be considered as positive when at least one positive fluorescent cell is detected.
Time frame: At day 11 after the first vaccination.
Microscopy assessment of the infectious activity of the measles vaccine virus presented in breast milk in at least one sample.
In case of detection of measles vaccine virus strain excretion in breast milk. The evaluation of the infectious activity of the measles vaccine virus will be performed using an in vitro infectivity assay. A result will be considered as positive when at least one positive fluorescent cell is detected.
Time frame: At day 14 after the first vaccination.
Number of infant with positive salivary IgM/IgG
Time frame: one year after the first vaccination
Ran from Feb 2015 to primary completion in May 2016, 14 months.
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