Study to Explore CMV Infection in Adolescent Girls

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01691820
First received: September 13, 2012
Last updated: April 24, 2014
Last verified: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35233
United States, Michigan
GSK Investigational Site
Stevensville, Michigan, United States, 49127
Finland
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Oulu, Finland, 90220
Mexico
GSK Investigational Site
Jojutla / Morelos, Mexico
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 24, 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 August 20, 2014