Study to Explore CMV Infection in Adolescent Girls

This study is currently recruiting participants.
Verified January 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01691820
First received: September 13, 2012
Last updated: April 3, 2014
Last verified: January 2014
  Purpose

This study aims to estimate the incidence of CMV secondary infections (re-infections/ re-activation) and the incidence of CMV primary infections in adolescent females.


Condition Intervention
Infections, Cytomegalovirus
Procedure: Blood collection
Procedure: Urine collection
Procedure: Dry urine collection
Procedure: Saliva collection
Procedure: Urine and/ or saliva collection from newborn in case of pregnancy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Study in Adolescent Females to Explore Cytomegalovirus Infection

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of CMV secondary infections determined in all seropositive subjects in terms of antibody concentrations and viral load. [ Time Frame: Every 4 months from Month 0 to Month 36 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 384
Study Start Date: October 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group S+
CMV seropositive subjects at inclusion
Procedure: Blood collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Procedure: 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.
Procedure: Dry urine collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Procedure: 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.
Procedure: Urine and/ or saliva collection from newborn in case of pregnancy
Samples collected upon delivery or within 10 days of delivery.
Experimental: Group S-
CMV seronegative subjects at inclusion
Procedure: Blood collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Procedure: 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.
Procedure: Dry urine collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Procedure: 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.
Procedure: Urine and/ or saliva collection from newborn in case of pregnancy
Samples collected upon delivery or within 10 days of delivery.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691820

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
United States, Alabama
GSK Investigational Site Recruiting
Birmingham, Alabama, United States, 35233
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Michigan
GSK Investigational Site Recruiting
Stevensville, Michigan, United States, 49127
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Finland
GSK Investigational Site Recruiting
Helsinki, Finland, 00100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Oulu, Finland, 90220
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Mexico
GSK Investigational Site Recruiting
Jojutla / Morelos, Mexico
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01691820     History of Changes
Other Study ID Numbers: 115639
Study First Received: September 13, 2012
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration
Finland: Ministry of Social Affairs and Health
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)

Keywords provided by GlaxoSmithKline:
Adolescent females
Cytomegalovirus (CMV)

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014