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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01251744
First received: November 30, 2010
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Infections, Cytomegalovirus
Procedure: Blood sample
Procedure: Cord blood sample
Procedure: Saliva swab
Procedure: Urine sampling
Procedure: Vaginal swab

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study of Maternal-foetal CMV Transmission

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of congenital CMV infection in newborns or foetuses of subjects who had a confirmed primary CMV infection during pregnancy. [ Time Frame: During pregnancy and at pregnancy conclusion. ] [ Designated as safety issue: No ]
  • Evidence of CMV in saliva, urine, blood or vaginal secretions of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: From study entry to, and including, pregnancy conclusion. ] [ Designated as safety issue: No ]
  • Assessment of antibody responses to CMV of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: Every two months from study entry to, and including, pregnancy conclusion. ] [ Designated as safety issue: No ]
  • Assessment of the cell-mediated immune responses of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: Every two months from study entry to, and including, pregnancy conclusion. ] [ Designated as safety issue: No ]
  • Evidence of CMV in saliva, urine, blood or vaginal secretions of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: Every month (saliva, urine, vaginal secretions) and every two months (blood) from study entry to, and including (except for vaginal secretions), pregnancy conclusion. ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: December 2010
Estimated Study Completion Date: June 2015
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A.
Not Applicable.
Procedure: Blood sample
Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Procedure: Cord blood sample
Cord blood sample taken at the time of delivery.
Procedure: Saliva swab
Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Procedure: Urine sampling
Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Procedure: Vaginal swab
Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251744

Locations
Belgium
GSK Investigational Site
Brussels, Belgium, 1000
GSK Investigational Site
Bruxelles, Belgium, 1070
GSK Investigational Site
Charleroi, Belgium, 6000
GSK Investigational Site
Ixelles, Belgium, 1050
GSK Investigational Site
La Louvière, Belgium, 7100
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Mons, Belgium, 7000
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01251744     History of Changes
Other Study ID Numbers: 113134
Study First Received: November 30, 2010
Last Updated: September 18, 2014
Health Authority: Belgium: Agence Fédérale des Médicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:
Pregnancy
Congenital
Cytomegalovirus infection

Additional relevant MeSH terms:
Communicable Diseases
Cytomegalovirus Infections
Infection
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014