Overview

This trial is active, not recruiting.

Condition infections, cytomegalovirus
Treatments blood collection, urine collection, saliva collection
Sponsor GlaxoSmithKline
Start date October 2012
End date April 2017
Trial size 363 participants
Trial identifier NCT01691820, 115639

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
CMV seropositive subjects at inclusion
blood collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
urine collection
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
saliva collection
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
(Experimental)
CMV seronegative subjects at inclusion
blood collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
urine collection
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
saliva collection
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.

Primary Outcomes

Measure
Occurrence of CMV secondary infections determined in all seropositive subjects on samples collected during the 4-month Site Visits until study conclusion.
time frame: Every 4 months from Month 0 to Month 36

Secondary Outcomes

Measure
Occurrence of CMV primary infections determined in all seronegative subjects in terms of antibody concentrations.
time frame: Every 4 months from Month 0 to Month 36

Eligibility Criteria

Female participants from 10 years up to 17 years old.

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.

Additional Information

Official title A Study in Adolescent Females to Explore Cytomegalovirus Infection
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.