A Study in Adolescent Females to Explore Cytomegalovirus Infection
2021. április 1. frissítette: GlaxoSmithKline
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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
369
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Alabama
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Birmingham, Alabama, Egyesült Államok, 35233
- GSK Investigational Site
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Michigan
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Stevensville, Michigan, Egyesült Államok, 49127
- GSK Investigational Site
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Helsinki, Finnország, 00260
- GSK Investigational Site
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Oulu, Finnország, 90220
- GSK Investigational Site
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Morelos
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Jojutla, Morelos, Mexikó, 62900
- GSK Investigational Site
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
10 év (Gyermek)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Női
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Szűrés
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Group S+
Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.
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Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
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Kísérleti: Group S-
Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.
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Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
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Kísérleti: Missing serostatus Group
Subjects with no confirmed serostatus, aged between 10-17 years at enrollment in the study.
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Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: At Month 4
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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.
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At Month 4
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: At Month 8
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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.
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At Month 8
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: At Month 12
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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.
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At Month 12
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: At Month 16
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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.
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At Month 16
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: At Month 20
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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.
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At Month 20
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: At Month 24
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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.
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At Month 24
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: At Month 28
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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.
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At Month 28
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: At Month 32
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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.
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At Month 32
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: At Month 36
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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.
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At Month 36
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: At Month 0
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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.
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At Month 0
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: At Month 4
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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).
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At Month 4
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: At Month 8
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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).
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At Month 8
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: At Month 12
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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).
|
At Month 12
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: 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).
|
At Month 16
|
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: 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).
|
At Month 20
|
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: 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).
|
At Month 24
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: 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)
|
At Month 28
|
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: 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).
|
At Month 32
|
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Időkeret: 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).
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At Month 36
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Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine
Időkeret: At Month 4
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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").
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At Month 4
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Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Időkeret: At Month 8
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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").
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At Month 8
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Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Időkeret: At Month 12
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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").
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At Month 12
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Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Időkeret: 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").
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At Month 16
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Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Időkeret: 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").
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At Month 20
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Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Időkeret: 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").
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At Month 24
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Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Időkeret: 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").
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At Month 28
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Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Időkeret: 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").
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At Month 32
|
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Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Időkeret: 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").
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At Month 36
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Időkeret: From study Month 0 to Month 36
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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.
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From study Month 0 to Month 36
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Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Időkeret: From study Month 0 to Month 36
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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.
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From study Month 0 to Month 36
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2012. október 5.
Elsődleges befejezés (Tényleges)
2017. április 8.
A tanulmány befejezése (Tényleges)
2017. április 8.
Tanulmányi regisztráció dátumai
Először benyújtva
2012. szeptember 13.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2012. szeptember 20.
Első közzététel (Becslés)
2012. szeptember 25.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2021. április 27.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2021. április 1.
Utolsó ellenőrzés
2021. március 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 115639
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .