Overview

This trial is active, not recruiting.

Condition pregnancy
Treatment determination of anti-rubella antibody, e1
Sponsor Hopital Foch
Start date February 2012
End date May 2014
Trial size 192 participants
Trial identifier NCT02934295, 2011-A01445-36, 2011/61

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
determination of anti-rubella antibody, e1

Primary Outcomes

Measure
Level of Anti-Rubella Antibody, E1
time frame: 8 months

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies
Principal investigator Olivier Picone
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hopital Foch.