Completed
A Study in Adolescent Females to Explore Cytomegalovirus Infection
What is being tested
Blood collection
+ Urine collection
+ Saliva collection
Procedure
Who is being recruted
DNA Virus Infections+2
+ Herpesviridae Infections
+ Infections
From 10 to 17 Years
+12 Eligibility Criteria
How is the trial designed
Screening Study
Interventional
Study Start: October 2012
Summary
Principal SponsorGlaxoSmithKline
Last updated: April 27, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: October 5, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorGlaxoSmithKline
Last updated: April 27, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
369 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Screening Study
Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 10 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
DNA Virus InfectionsHerpesviridae InfectionsInfectionsVirus DiseasesCytomegalovirus Infections
Criteria
4 inclusion criteria required to participate
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
Subject is likely to remain in the area and/or return for required study Site Visits and complete Sample Collection Visits
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
8 exclusion criteria prevent from participating
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
Child in care
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalCytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.
Group II
ExperimentalCytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.
Group III
ExperimentalSubjects with no confirmed serostatus, aged between 10-17 years at enrollment in the study.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
GSK Investigational Site
Stevensville, United StatesGSK Investigational Site
Helsinki, FinlandGSK Investigational Site
Oulu, FinlandCompleted5 Study Centers