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

Launched by GLAXOSMITHKLINE · Dec 1, 2010

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

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.