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

Pregnancy Clinical Trial

— ImmRubVac  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934295
• Other study ID #: 2011/61
• Secondary ID: 2011-A01445-36
• Status: Completed
• Phase: N/A
• First received: October 13, 2016
• Last updated: January 31, 2017
• Start date: February 2012
• Est. completion date: October 2014

Study information

• Verified date: January 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pregnancy
• Rubella

Intervention

Biological:
• Determination of Anti-Rubella Antibody, E1

Locations

Country	Name	City	State
France	Hôpital Antoine-Béclère	Clamart
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Anti-Rubella Antibody, E1		8 months