Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With MMR
Condition: Measles; Rubella; Mumps
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®
Intervention type(s): Biological
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine strain excretion in breast milk; Postpartum vaccination; Breastfeeding women; Measles-mumps-rubella vaccine; Breast milk; Vaccinology