A Study in Adolescent Females to Explore Cytomegalovirus Infection

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Cytomegalovirus

Treatments: Procedure: Saliva collection; Procedure: Urine collection; Procedure: Blood collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01691820

115639

Details and patient eligibility

About

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.

Enrollment: 369 patients

Sex: Female

Ages: 10 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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369 participants in 3 patient groups

Group S+

Experimental group

Description:

Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.

Treatment:

Procedure: Urine collection

Procedure: Blood collection

Procedure: Saliva collection

Group S-

Experimental group

Description:

Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.

Treatment:

Procedure: Urine collection

Procedure: Blood collection

Procedure: Saliva collection

Missing serostatus Group

Experimental group

Description:

Subjects with no confirmed serostatus, aged between 10-17 years at enrollment in the study.

Treatment:

Procedure: Urine collection

Procedure: Blood collection

Procedure: Saliva collection