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

NCT ID: NCT02934295

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-10-31

Brief Summary

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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

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Conditions

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Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pregnant women

Group Type EXPERIMENTAL

Determination of Anti-Rubella Antibody, E1

Intervention Type BIOLOGICAL

Interventions

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Determination of Anti-Rubella Antibody, E1

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Picone

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Christelle VAULOUP-FELLOUS, MD

Role: STUDY_CHAIR

Hôpital Brousse

Locations

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Hôpital Antoine-Béclère

Clamart, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2011-A01445-36

Identifier Type: OTHER

Identifier Source: secondary_id

2011/61

Identifier Type: -

Identifier Source: org_study_id

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