NCT02325310

Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With MMR

Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With a Combined Measles-mumps-rubella (MMR) Vaccine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Measles
• Rubella
• Mumps

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-02-04
• Primary completion: 2016-05-03
• Completion: 2017-11-01
• First posted: 2014-12-24
• Last updated: 2026-03-30

Locations

1 site across 1 country: France