A Study in Adolescent Females to Explore Cytomegalovirus Infection
1. dubna 2021 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Dokončeno
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Intervenční
Zápis (Aktuální)
Zápis
369
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Helsinki, Finsko, 00260
- GSK Investigational Site
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Oulu, Finsko, 90220
- GSK Investigational Site
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Morelos
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Jojutla, Morelos, Mexiko, 62900
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, Spojené státy, 35233
- GSK Investigational Site
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Michigan
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Stevensville, Michigan, Spojené státy, 49127
- GSK Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
10 let až 17 let (Dítě)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Promítání
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
3
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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Experimentální: 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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Experimentální: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Časové okno: 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.
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At Month 4
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Časové okno: 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.
|
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.
Časové okno: 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.
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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.
Časové okno: 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.
|
At Month 16
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Časové okno: 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.
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At Month 20
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Časové okno: 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.
|
At Month 24
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Časové okno: 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.
|
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.
Časové okno: 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.
|
At Month 32
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Časové okno: 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.
|
At Month 36
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Časové okno: 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.
|
At Month 0
|
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Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Časové okno: 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).
|
At Month 4
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Časové okno: 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).
|
At Month 8
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Časové okno: 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).
|
At Month 12
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Časové okno: 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
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Časové okno: 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
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Časové okno: 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).
Časové okno: 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
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Časové okno: 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
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Časové okno: 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).
|
At Month 36
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine
Časové okno: 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").
|
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
Časové okno: 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").
|
At Month 8
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Časové okno: 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").
|
At Month 12
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Časové okno: 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").
|
At Month 16
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Časové okno: 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").
|
At Month 20
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Časové okno: 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").
|
At Month 24
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Časové okno: 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").
|
At Month 28
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Časové okno: 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").
|
At Month 32
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Časové okno: 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").
|
At Month 36
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Časové okno: 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.
|
From study Month 0 to Month 36
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Časové okno: 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.
|
From study Month 0 to Month 36
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
5. října 2012
Primární dokončení (Aktuální)
Primární dokončení
8. dubna 2017
Dokončení studie (Aktuální)
Dokončení studie
8. dubna 2017
Termíny zápisu do studia
První předloženo
První předloženo
13. září 2012
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
20. září 2012
První zveřejněno (Odhad)
První zveřejněno
25. září 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
27. dubna 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. dubna 2021
Naposledy ověřeno
Naposledy ověřeno
1. března 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 115639
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ne
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