Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

Brief Title

Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

Official Title

Study of Maternal-foetal Cytomegalovirus (CMV) Transmission

Brief Summary

      This study is designed to evaluate maternal virological and immunological parameters to
      determine their ability to predict congenital cytomegalovirus (CMV) infection. When a
      pregnant woman is infected with CMV, her immune system (which protects her from infection) is
      activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine,
      vaginal secretions). The aim of this study is to find out if there is a link between either
      the pregnant woman's immune response or the presence of the virus in these bodily fluids and
      the child/foetus being infected with the virus.
    



Study Type

Interventional


Primary Outcome

Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection


Condition

Infections, Cytomegalovirus

Intervention

Blood sample

Study Arms / Comparison Groups

 CMV Mothers' Group
Description:  Pregnant subjects with confirmed primary CMV infection.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

160

Start Date

December 9, 2010

Completion Date

June 17, 2015

Primary Completion Date

November 6, 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol .

          -  A pregnant female, 18 years of age or older at the time of study enrolment.

          -  Women with confirmed primary CMV infection.

          -  Written informed consent obtained from the subject.

        Exclusion Criteria:

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to study entry.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational pharmaceutical product.

          -  Previous vaccination against CMV infection.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history or physical examination

          -  Major congenital defects, serious chronic illness or organ transplantation.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding study enrolment or during the pregnancy.

          -  Documented Human immunodeficiency virus (HIV)-positive subject.

          -  Gestational age of more than 34 weeks, as determined by foetal ultrasound.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

GSK Clinical Trials, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01251744

Organization ID

113134


Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline


Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline


Verification Date

May 2020