A Study in Adolescent Females to Explore Cytomegalovirus Infection

Completed · Not applicable

Conditions studied: Infections, Cytomegalovirus

In brief

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.

Key facts

Study ID

NCT01691820

Run by

GlaxoSmithKline

People needed

369

Starts

2012-10-05

Expected to finish

2017-04-08

Last updated by the study team

2021-04-27

Who can join

Age: 10 and older, up to 17. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Stevensville, Michigan, United States
• GSK Investigational Site — Helsinki, Finland
• GSK Investigational Site — Oulu, Finland
• GSK Investigational Site — Jojutla, Morelos, Mexico

Full record on ClinicalTrials.gov

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