MeaslesPhase 4BREMEAVACNCT02325310
Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With MMR
A Phase 4 study testing Combined measles-mumps-rubella (MMR) vaccine - PRIORIX® in people with Measles and Rubella, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 36 years
- What is being tested?
- Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2015to 1 Nov 2017
- 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 36 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Women:
- Pregnant woman
- Age ≥ 18 years
- Planning to breastfeed her infant (mixed feeding is allowed)
- Having a negative serology for rubella during pregnancy
- Negative serology for measles based on the result from local laboratory
Show all 10Show fewer
- Affiliated to a social security regimen
- Infants:
- Informed consent form signed by the person(s) holding parental authority.
- Term newborn (≥36LMP)
Who cannot join
- Women:
- Woman having a multiple pregnancy
- Woman planning to get pregnant in the month following the 2nd vaccination
- Woman with known or suspected HIV infection
- Woman with known or suspected immunodeficiency
- Woman with family history of hereditary immune deficiency
Show all 22Show fewer
- Woman not mastering enough the reading / understanding of the French language to be able to consent to participate to the study
- Woman incapable to follow the procedures of the study and to respect study visits for the whole period of the study.
- Woman with contraindication for MMR vaccination:
- Scarce hereditary problems of fructose intolerance
- Woman with history of hypersensitivity to the active substances or to any of the excipients of the vaccine
- Administration of human gammaglobulins in the past 3 to 11 months depending on the dose of human globulins administered (except for Rhophylac®)
- Acute severe febrile illness within 7 days prior to injection
- Woman under systemic corticosteroids (prednisone, or equivalent ≥10 mg/day) within the previous 15 days or planning to use corticosteroids (i.e. prednisone, or equivalent ≥10 mg/day) during the 15 days following vaccination
- Woman under immunosuppressive therapy within the previous 3 months before vaccination or planning to use immunosuppressive therapy during the 15 days following vaccination Woman participating in any clinical trial with another investigational product 28 days prior to visit V0 or intent to participate in another clinical study with another investigational product at any time during the conduct of this study
- Any other reason which, according to the investigator, may interfere with the evaluation of the study objectives
- Woman with documented history of measles vaccination (1 or 2 doses) and/or history of documented measles
- Infants:
- Blood draw is contraindicated or cannot be performed
- Infant with family history of hereditary immune deficiency
- Infant with suspected or confirmed immunodeficiency
- Any other reason which, according to the investigator, may interfere with the evaluation of the study objectives
Trial locations and contacts
1 site in 1 country.
France1 site
Cochin Port Royal Hospital - Centre d'Investigation Clinique Cochin-Pasteur
Paris, 75014
About this study
Official title: Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With a Combined Measles-mumps-rubella (MMR) Vaccine
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.
Read the detailed description
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.
- Being tested
- Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®
- Keywords
- Vaccine strain excretion in breast milk, Postpartum vaccination, Breastfeeding women, Measles-mumps-rubella vaccine, Breast milk, Vaccinology
- Medical subject headings
- Measles, Rubella, Mumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding women | Experimental | 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) Receives: Biological: Combined measles-mumps-rubella (MMR) vaccine - PRIORIX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: day 14 after the first vaccination.
Secondary outcomes (15)
Number of infants with reported clinical symptoms of measles
Evaluation of the clinical impact of MMR vaccination in breastfeeding infant
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At day 14 after the first vaccination.
Number of infant with positive salivary IgM/IgG
Measured: one year after the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study start4 Feb 2015
- Primary completion3 May 2016
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Service de Bactériologie-Virologie-Hygiène, CHU Limoge, GO-CIC network (Réseau Gynéco-Obstetrical des Centres d'Investigation Clinique), REIVAC network (Réseau National d'Investigation Clinique en Vaccinologie), URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Odile Launay, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325310
- Sponsor's protocol ID
- 2014-001538-28
- Other IDs
- 2014
- Acronym
- BREMEAVAC
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2014
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Alain S, Dommergues MA, Jacquard AC, Caulin E, Launay O. State of the art: Could nursing mothers be vaccinated with attenuated live virus vaccine? Vaccine. 2012 Jul 13;30(33):4921-6. doi: 10.1016/j.vaccine.2012.05.047. Epub 2012 May 31.
PubMed 22659446Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Yellow fever virus transmission via breastfeeding: follow-up to the paper on breastfeeding travelers. J Travel Med. 2010 Jul-Aug;17(4):286-7. doi: 10.1111/j.1708-8305.2010.00430.x. No abstract available.
PubMed 20636609Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. I. Development and characterization of specific immunologic reactivity in breast milk. J Infect Dis. 1982 May;145(5):654-60. doi: 10.1093/infdis/145.2.654.
PubMed 7077089Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. II. Maternal-neonatal interactions. J Infect Dis. 1982 May;145(5):661-6. doi: 10.1093/infdis/145.2.661.
PubMed 7077090
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With a Combined Measles-mumps-rubella (MMR) Vaccine
- ClinicalTrials.gov ID
- NCT02325310
- Acronym / sponsor ID
- BREMEAVAC / 2014-001538-28
- Keywords
- Vaccine strain excretion in breast milk, Postpartum vaccination, Breastfeeding women, Measles-mumps-rubella vaccine, Breast milk, Vaccinology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Service de Bactériologie-Virologie-Hygiène, CHU Limoge, GO-CIC network (Réseau Gynéco-Obstetrical des Centres d'Investigation Clinique), REIVAC network (Réseau National d'Investigation Clinique en Vaccinologie), URC-CIC Paris Descartes Necker Cochin
- Study start
- 4 Feb 2015 (actual)
- Primary completion
- 3 May 2016 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 24 Dec 2014 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding women | Experimental | Biological: Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®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) |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Pregnant woman
- Age ≥ 18 years
- Planning to breastfeed her infant (mixed feeding is allowed)
- Having a negative serology for rubella during pregnancy
- Negative serology for measles based on the result from local laboratory
Key exclusion criteria (22 listed)
- Woman having a multiple pregnancy
- Woman planning to get pregnant in the month following the 2nd vaccination
- Woman with known or suspected HIV infection
- Woman with known or suspected immunodeficiency
- Woman with family history of hereditary immune deficiency
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 |
|---|---|---|
| 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. | Biological | Breastfeeding women |
Primary outcome
Prevalence of the measles vaccine virus strain in breast milk.
Time frame: day 7 after the first vaccination.
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
Prevalence of the measles vaccine virus strain in breast milk.
Time frame: day 11 after the first vaccination.
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
Prevalence of the measles vaccine virus strain in breast milk.
Time frame: day 14 after the first vaccination.
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
15 secondary outcomes
Number of infants with reported clinical symptoms of measles
Time frame: At V1 Visit (8 weeks +/- 15 days)
Number of infants with reported clinical symptoms of measles
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
Time frame: V1 Visit (8 weeks +/- 15 days) after the first MMR vaccination
Number of women with reported clinical symptoms of measles
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)
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
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
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
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
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
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
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.
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.
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.
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
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 30 Mar 2026.
- Background: PubMed 22659446Alain S, Dommergues MA, Jacquard AC, Caulin E, Launay O. State of the art: Could nursing mothers be vaccinated with attenuated live virus vaccine? Vaccine. 2012 Jul 13;30(33):4921-6. doi: 10.1016/j.vaccine.2012.05.047. Epub 2012 May 31.
- Background: PubMed 20636609Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Yellow fever virus transmission via breastfeeding: follow-up to the paper on breastfeeding travelers. J Travel Med. 2010 Jul-Aug;17(4):286-7. doi: 10.1111/j.1708-8305.2010.00430.x. No abstract available.
- Background: PubMed 7077089Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. I. Development and characterization of specific immunologic reactivity in breast milk. J Infect Dis. 1982 May;145(5):654-60. doi: 10.1093/infdis/145.2.654.
- Background: PubMed 7077090Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. II. Maternal-neonatal interactions. J Infect Dis. 1982 May;145(5):661-6. doi: 10.1093/infdis/145.2.661.
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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.
Odile Launay, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
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 Combined measles-mumps-rubella (MMR) vaccine - PRIORIX® in people with Measles and Rubella, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 22 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 30 Mar 2026. 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 France. 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?
Prevalence of the measles vaccine virus strain in breast milk. (time frame: day 7 after the first vaccination.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325310, which also lists 4 linked publications.
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 30 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.