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

NCT02325310 | Completed Phase 4

• 1 other identifier: 2014-001538-28
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Measles; Rubella; Mumps

Keywords

Vaccine strain excretion in breast milk; Postpartum vaccination; Breastfeeding women; Measles-mumps-rubella vaccine; Breast milk; Vaccinology

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  day 14 after the first vaccination.

Secondary Outcomes (15)

• Number of infants with reported clinical symptoms of measles

  At V1 Visit (8 weeks +/- 15 days)

• Number of infants with reported clinical symptoms of measles

  Between V0 visit and V1 visit (8 weeks +/- 15 days) after the first MMR vaccination

• Number of women with reported clinical symptoms of measles

  V1 Visit (8 weeks +/- 15 days) after the first MMR vaccination

• Number of women with reported clinical symptoms of measles

  Between V0 visit and V1 visit (8 weeks +/- 15 days) after the first MMR vaccination

• Number of infants with positive measles serology (IgM)

  V1 visit (8 weeks +/- 15 days) after the first MMR vaccination

Study Arms (1)

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)

Biological: Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®

Interventions

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.

Breastfeeding women

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Service de Bactériologie-Virologie-Hygiène, CHU Limoge: collaborator
• GO-CIC network (Réseau Gynéco-Obstetrical des Centres d'Investigation Clinique): collaborator
• REIVAC network (Réseau National d'Investigation Clinique en Vaccinologie): collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Port Royal Hospital - Centre d'Investigation Clinique Cochin-Pasteur

Paris, 75014, France

Location

Related Publications (4)

• 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.

  PMID: 22659446 BACKGROUND

• Chen 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.

  PMID: 20636609 BACKGROUND

• Losonsky 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.

  PMID: 7077089 BACKGROUND

• Losonsky 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.

  PMID: 7077090 BACKGROUND

MeSH Terms

Conditions

Measles; Rubella; Mumps

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubivirus Infections; Togaviridae Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Odile Launay, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: February 4, 2015
• Primary Completion: May 3, 2016
• Study Completion: November 1, 2017
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (1)