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OpenTrials
Completed

NCT Number: NCT02934295

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

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.

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Key information

Conditions

Pregnancy Infections Measles Mononegavirales Infections Morbillivirus Infections Paramyxoviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Antoine-Béclère, Clamart, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Determination of Anti-Rubella Antibody, E1

Biological

Primary outcomes

  1. Level of Anti-Rubella Antibody, E1

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: ImmRubVac

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 14, 2016
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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