A Study in Adolescent Females to Explore Cytomegalovirus Infection
2021年4月1日 更新者：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.
研究概览
研究类型
介入性
注册 (实际的)
369
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
女性
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
实验性的：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.
|
|
实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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).
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年10月5日
初级完成 (实际的)
2017年4月8日
研究完成 (实际的)
2017年4月8日
研究注册日期
首次提交
2012年9月13日
首先提交符合 QC 标准的
2012年9月20日
首次发布 (估计)
2012年9月25日
研究记录更新
最后更新发布 (实际的)
2021年4月27日
上次提交的符合 QC 标准的更新
2021年4月1日
最后验证
2021年3月1日
更多信息
与本研究相关的术语
其他研究编号
- 115639
计划个人参与者数据 (IPD)
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Blood collection的临床试验
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Cliniques universitaires Saint-Luc- Université...Université de Liège招聘中