Skip to main content
OpenTrials
Completed

NCT Number: NCT01691820

A Study in Adolescent Females to Explore Cytomegalovirus Infection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infections, Cytomegalovirus Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

10 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site, Helsinki, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Collection

Procedure

Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.

Urine collection

Procedure

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

Procedure

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

  1. Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: At Month 4

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

  2. Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: At Month 8

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

  3. Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: At Month 12

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

  4. Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: At Month 16

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

  5. Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: At Month 20

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

  6. Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: At Month 24

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

  7. Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: At Month 28

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

  8. Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: At Month 32

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

  9. Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: At Month 36

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

  10. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 0

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.

  11. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 4

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

  12. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 8

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

  13. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 12

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

  14. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 16

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

  15. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 20

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

  16. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 24

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

  17. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 28

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point)

  18. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 32

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

  19. Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).

    Time frame: At Month 36

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

  20. Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine

    Time frame: At Month 4

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").

  21. Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine

    Time frame: At Month 8

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").

  22. Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine

    Time frame: At Month 12

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

  23. Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine

    Time frame: At Month 16

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

  24. Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine

    Time frame: At Month 20

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

  25. Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine

    Time frame: At Month 24

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

  26. Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine

    Time frame: At Month 28

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").

  27. Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine

    Time frame: At Month 32

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

  28. Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine

    Time frame: At Month 36

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

Secondary outcomes

  1. Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.

    Time frame: From study Month 0 to Month 36

    This outcome was part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegative subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment.

  2. Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects

    Time frame: From study Month 0 to Month 36

    This outcome is part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegatve subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2012
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.