A Study in Adolescent Females to Explore Cytomegalovirus Infection
2021년 4월 1일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
369
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
10년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
실험적: 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.
|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2012년 10월 5일
기본 완료 (실제)
기본 완료
2017년 4월 8일
연구 완료 (실제)
연구 완료
2017년 4월 8일
연구 등록 날짜
최초 제출
최초 제출
2012년 9월 13일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
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처음 게시됨 (추정)
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연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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마지막으로 확인됨
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 115639
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .