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

Hopital Foch2 sites in 1 country192 target enrollmentFebruary 2012

ConditionsPregnancy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pregnancy
Sponsor: Hopital Foch
Enrollment: 192
Locations: 2
Primary Endpoint: Level of Anti-Rubella Antibody, E1
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

October 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Hopital Foch

Responsible Party

Sponsor

Eligibility Criteria

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)