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

• 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 ]

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.

• Infections, Cytomegalovirus
• Transmission of Cytomegalovirus Infection From Pregnant Woman to Foetus

• 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.

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.