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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02934295 |
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Date of registration:
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13/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies
ImmRubVac |
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Scientific title:
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Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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192 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02934295 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Christelle VAULOUP-FELLOUS, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital Brousse |
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Name:
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Olivier Picone |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital Foch |
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Key inclusion & exclusion 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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
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Intervention(s)
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Biological: Determination of Anti-Rubella Antibody, E1
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Primary Outcome(s)
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Level of Anti-Rubella Antibody, E1
[Time Frame: 8 months]
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Secondary ID(s)
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2011/61
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2011-A01445-36
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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