A Study in Adolescent Females to Explore Cytomegalovirus Infection
1 kwietnia 2021 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
369
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Helsinki, Finlandia, 00260
- GSK Investigational Site
-
Oulu, Finlandia, 90220
- GSK Investigational Site
-
-
-
-
Morelos
-
Jojutla, Morelos, Meksyk, 62900
- GSK Investigational Site
-
-
-
-
Alabama
-
Birmingham, Alabama, Stany Zjednoczone, 35233
- GSK Investigational Site
-
-
Michigan
-
Stevensville, Michigan, Stany Zjednoczone, 49127
- GSK Investigational Site
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
10 lat do 17 lat (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Ekranizacja
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Group S+
Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.
|
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.
|
|
Eksperymentalny: Group S-
Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.
|
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.
|
|
Eksperymentalny: Missing serostatus Group
Subjects with no confirmed serostatus, aged between 10-17 years at enrollment in the study.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Ramy czasowe: 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.
|
At Month 4
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Ramy czasowe: 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
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Ramy czasowe: 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.
|
At Month 12
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Ramy czasowe: 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.
Ramy czasowe: 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.
|
At Month 20
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Ramy czasowe: 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.
Ramy czasowe: 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
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Ramy czasowe: 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.
Ramy czasowe: 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).
Ramy czasowe: 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
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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
Ramy czasowe: 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
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
5 października 2012
Zakończenie podstawowe (Rzeczywisty)
8 kwietnia 2017
Ukończenie studiów (Rzeczywisty)
8 kwietnia 2017
Daty rejestracji na studia
Pierwszy przesłany
13 września 2012
Pierwszy przesłany, który spełnia kryteria kontroli jakości
20 września 2012
Pierwszy wysłany (Oszacować)
25 września 2012
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
27 kwietnia 2021
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 kwietnia 2021
Ostatnia weryfikacja
1 marca 2021
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 115639
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .