Breastfeeding after MMR shot: is it safe for baby?
NCT ID NCT02325310
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether the measles vaccine virus can be found in the breast milk of new mothers who received the MMR vaccine shortly after giving birth. Fourteen breastfeeding women with no immunity to measles or rubella provided milk samples over two weeks. The goal was to understand if the vaccine could affect their babies, helping doctors give better safety advice.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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14 people
The number who actually took part.
- Started
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Feb 2015
- Finished
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Nov 2017
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 36 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 * Affiliated to a social security regimen Infants: * Informed consent form signed by the person(s) holding parental authority. * Term newborn (≥36LMP) Exclusion Criteria: 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cochin Port Royal Hospital - Centre d'Investigation Clinique Cochin-Pasteur
Paris, 75014, France
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Other studies related to the condition(s) this trial covers.
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