Status:
COMPLETED
Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Cytomegalovirus
Cytomegalovirus Infections
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2015
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01251744
Start Date
December 9 2010
End Date
June 17 2015
Last Update
June 29 2020
Active Locations (9)
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1
GSK Investigational Site
Brussels, Belgium, 1000
2
GSK Investigational Site
Brussels, Belgium, 1050
3
GSK Investigational Site
Brussels, Belgium, 1070
4
GSK Investigational Site
Charleroi, Belgium, 6000