A Study in Adolescent Females to Explore Cytomegalovirus Infection

A Study in Adolescent Females to Explore Cytomegalovirus Infection

The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary infections (re-infections/re-activations) and the incidence of CMV primary infections in adolescent females.

Inclusion Criteria:

• A female adolescent between, and including 10 and 17 years at the time of enrolment regardless of pregnancy status and contraception method used or not used.
• Subjects who the investigator believes that the subject and/or the subject's parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol.
• Written informed assent and/or consent obtained from the subject and/or the parent(s)/LAR(s) of the subject.
• Subject is likely to remain in the area and/or return for required study Site Visits and complete Sample Collection Visits.

Exclusion Criteria:

• Child in care.
• Use or planned use of any investigational or non-registered antiviral drug or vaccine during the study period.
• Known medical history of any recurrent clinical herpes episodes requiring episodic or chronic suppressive treatment with oral or parenteral antiviral treatment such as acyclovir, famciclovir, valacyclovir or any other anti-herpes virus anti-viral during the year preceding enrolment. Topical anti-viral are allowed.
• Subjects with history of previous vaccination against CMV.
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to Visit 1 or planned administration during the study. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products within 3 months prior to Visit 1 or planned administration during the study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition including HIV-infection, based on medical history and physical examination (no laboratory testing required).
• Any major congenital defects, serious chronic illness or organ transplantation.