Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies

Not Applicable

Completed

• Conditions: Pregnancy

• Registration Number: NCT02934295
• Lead Sponsor: Hopital Foch

Brief Summary

The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-05
• Study Completion: 2014-10
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-14
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

Inclusion Criteria

• Women over 18
• Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy
• Accepting the rubella vaccination after the childbirth;
• Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella.
• Affiliated to a social security scheme
• Having given a written consent

Exclusion Criteria

• Rubella contracted since the first serology realized during the first prenatal consultation
• Autoimmune pathologies
• Intolerance / allergy known about a previous vaccination whatever it is
• Immunosuppression (HIV, transplants)
• Injection of multivalent immunoglobulins (except anti-D)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Level of Anti-Rubella Antibody, E1	8 months

Trial Locations

Locations (2)

Hôpital Antoine-Béclère; 🇫🇷 Clamart, France

Hôpital Foch; 🇫🇷 Suresnes, France