Back to resultsStudy of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies (ImmRubVac)
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Determination of Anti-Rubella Antibody, E1
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Rubeola
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)
Sites / Locations
- Hôpital Antoine-Béclère
- Hôpital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pregnant women
Arm Description
Outcomes
Primary Outcome Measures
Level of Anti-Rubella Antibody, E1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02934295
Brief Title
Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies
Acronym
ImmRubVac
Official Title
Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Rubeola
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregnant women
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Determination of Anti-Rubella Antibody, E1
Primary Outcome Measure Information:
Title
Level of Anti-Rubella Antibody, E1
Time Frame
8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Picone
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christelle VAULOUP-FELLOUS, MD
Organizational Affiliation
Hôpital Brousse
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Antoine-Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies
We'll reach out to this number within 24 hrs