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Trial record 38 of 47 for:    congenital CMV

Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01251744
Recruitment Status : Completed
First Posted : December 2, 2010
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Infections, Cytomegalovirus
Cytomegalovirus Infections
Interventions Procedure: Blood sample
Procedure: Cord blood sample
Procedure: Saliva swab
Procedure: Urine sampling
Procedure: Vaginal swab
Enrollment 160
Recruitment Details  
Pre-assignment Details Out of 82 pregnant subjects enrolled, 77 started this study: 4 were excluded from stat analyses; 1 had no available cytomegalovirus (CMV) infection status (IS) of her offsprings. Out of 82 offsprings, 78 newborns were enrolled (mothers signed informed consent) and 4 foetuses (stillbirth/termination) had CMV IS available but were not enrolled.
Arm/Group Title CMV Mothers' Group CMV Newborns' Group
Hide Arm/Group Description Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection. Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
Period Title: Overall Study
Started 77 78
Completed 76 78
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title CMV Mothers' Group CMV Newborns' Group Total
Hide Arm/Group Description Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection. Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born. Total of all reporting groups
Overall Number of Baseline Participants 77 78 155
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 0 participants 77 participants
29.4  (4.8) 29.4  (4.8)
[1]
Measure Analysis Population Description: This analysis presents data only for the CMV Mothers' Group.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 0 participants 78 participants 78 participants
38.7  (2.5) 38.7  (2.5)
[1]
Measure Analysis Population Description: This analysis presents data only for the CMV Newborns' Group.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 78 participants 155 participants
Female
77
 100.0%
42
  53.8%
119
  76.8%
Male
0
   0.0%
36
  46.2%
36
  23.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White - Arabic / North African Heritage Number Analyzed 77 participants 78 participants 155 participants
3
   3.9%
2
   2.6%
5
   3.2%
White - Caucasian / European Heritage Number Analyzed 77 participants 78 participants 155 participants
74
  96.1%
71
  91.0%
145
  93.5%
Unspecified Number Analyzed 77 participants 78 participants 155 participants
0
   0.0%
5
   6.4%
5
   3.2%
1.Primary Outcome
Title Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection
Hide Description The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Enrolled cohort of Infant subjects, which included the newborns' group diagnosed with CMV infection and who had their medical records reviewed 1 month after birth and every 6 months for 2 years and foetus group, referring to infants that were stillborn or with pregnancy termination.
Arm/Group Title CMV Offsprings' Group CMV Newborns' Group CMV Foetus Group
Hide Arm/Group Description:
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
Overall Number of Participants Analyzed 82 78 4
Measure Type: Count of Participants
Unit of Measure: Participants
Confirmed CMV infection
24
  29.3%
20
  25.6%
4
 100.0%
Not confirmed CMV infection
58
  70.7%
58
  74.4%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With CMV Presence in the Urine
Hide Description Evidence of infection in urine was assessed by culture or by Polymerase Chain Reaction (PCR).
Time Frame Within 10 days post-delivery (Days 0-9)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the newborn sub-group in the Total Enrolled cohort of Infant subjects, which included the subjects diagnosed with CMV infection and who had their medical records reviewed 1 month after birth and every 6 months for 2 years.
Arm/Group Title CMV Newborns' Group
Hide Arm/Group Description:
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Positive: PCR Not Done/Culture Positive
6
   7.7%
Positive: PCR Positive/Culture Negative
5
   6.4%
Positive: PCR Positive/Culture Not Done
5
   6.4%
Positive: PCR Positive/Culture Positive
4
   5.1%
Negative: PCR Negative/Culture Negative
19
  24.4%
Negative: PCR Negative/Culture Not Done
6
   7.7%
Negative: PCR Not Done/Culture Negative
32
  41.0%
Not Done: PCR Not Done/Culture Not Done
1
   1.3%
3.Primary Outcome
Title Number of Subjects With CMV Presence in the Amniotic Fluid
Hide Description Evidence of infection in the amniotic fluid was assessed by culture or by Polymerase Chain Reaction (PCR).
Time Frame Within 10 days post-delivery (Days 0-9)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Enrolled cohort of Infant subjects, which included the newborns sub-group diagnosed with CMV infection and who had their medical records reviewed 1 month after birth and every 6 months for 2 years and foetus sub-group, referring to infants that were stillborn or with pregnancy termination.
Arm/Group Title CMV Infant Group CMV Newborn Sub-Group CMV Foetus Sub-Group
Hide Arm/Group Description:
Offspring of the CMV Mothers' Group, also tested for CMV infection.
For the purpose of the analysis, this sub-group was divided from the CMV Infant Group, comprising infants that were live born.
For the purpose of the analysis, this sub-group was divided from the CMV Infant Group, comprising infants that were stillborn or with pregnancy termination.
Overall Number of Participants Analyzed 82 78 4
Measure Type: Count of Participants
Unit of Measure: Participants
Positive: PCR Positive/Culture Negative
9
  11.0%
7
   9.0%
2
  50.0%
Positive: PCR Positive/Culture Positive
6
   7.3%
4
   5.1%
2
  50.0%
Negative: PCR Negative/Culture Negative
28
  34.1%
28
  35.9%
0
   0.0%
Negative: PCR Negative/Culture Not Done
9
  11.0%
9
  11.5%
0
   0.0%
Not Done: PCR Not Done/Culture Not Done
30
  36.6%
30
  38.5%
0
   0.0%
4.Primary Outcome
Title Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus
Hide Description [Not Specified]
Time Frame Within 10 days post-delivery (Days 0-9)
Hide Outcome Measure Data
Hide Analysis Population Description
The diagnosis of CMV in the newborn was done according to the local standard of care and samples were not collected for this analysis.
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
Hide Description The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine, blood and vaginal secretions every month from study entry to, and including, pregnancy conclusion.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: CMV DNA copies/sample
Buffy coat
0.000
(0.000 to 0.000)
Plasma
0.000
(0.000 to 0.000)
Saliva
0.000
(0.000 to 497.000)
Urine
1050.000
(0.000 to 3690.000)
Vaginal mucus
1950.000
(280.000 to 11510.00)
6.Primary Outcome
Title Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
Hide Description The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine and blood every month from study entry to, and including, pregnancy conclusion.
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Enrolled cohort, which included all pregnant subjects enrolled in this study, with available CMV infection status for their infants.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: CMV DNA copies/sample
Buffy coat
0.000
(0.000 to 0.000)
Plasma
0.000
(0.000 to 0.000)
Saliva
0.000
(0.000 to 231.500)
Urine
311.000
(0.000 to 1370.000)
Vaginal mucus
1950.000
(280.000 to 11510.00)
7.Primary Outcome
Title Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
Hide Description Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 69
Measure Type: Count of Participants
Unit of Measure: Participants
Positive
53
  76.8%
Negative
12
  17.4%
Grey Zone
4
   5.8%
8.Primary Outcome
Title Descriptive Statistics of the Anti-CMV IgM Status
Hide Description Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 56
Measure Type: Count of Participants
Unit of Measure: Participants
Positive
27
  48.2%
Negative
24
  42.9%
Grey Zone
5
   8.9%
9.Primary Outcome
Title Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
Hide Description Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Time Frame At Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
Positive
8
  34.8%
Negative
13
  56.5%
Grey Zone
2
   8.7%
10.Primary Outcome
Title Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics
Hide Description Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
Positive
1
  25.0%
Negative
3
  75.0%
11.Primary Outcome
Title Descriptive Statistics for the Anti-CMV IgM Status
Hide Description Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 64
Measure Type: Count of Participants
Unit of Measure: Participants
Positive
24
  37.5%
Negative
35
  54.7%
Grey Zone
5
   7.8%
12.Primary Outcome
Title Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations
Hide Description Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 69
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
4460.8
(3432.2 to 5797.6)
13.Primary Outcome
Title Anti-gB IgG Antibody Concentrations
Hide Description Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
6708.2
(5835.9 to 7711.0)
14.Primary Outcome
Title Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index
Hide Description The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: Percentage (avidity index)
22.000
(17.000 to 35.000)
15.Primary Outcome
Title Descriptive Statistics of the Anti-gB IgG Avidity Index
Hide Description The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: Percentage (avidity index)
36.500
(28.000 to 43.000)
16.Primary Outcome
Title CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
Hide Description Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among: cluster of differentiation 40 ligand (CD40L), interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among Human Cytomegalovirus [HCMV] immediate-early gene [IE1] antigen, HCMV glicoprotein B [gB] antigen, HCMV lysate antigen and HCMV pp65 antigen).
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: CMV-specific CD4 T cells/million T-cells
HCMV IE1 Ag Number Analyzed 64 participants
350.50
(101.50 to 633.00)
HCMV gB Ag Number Analyzed 64 participants
1009.50
(381.00 to 3395.00)
HCMV lysate Ag Number Analyzed 64 participants
2864.00
(1396.00 to 5980.00)
HCMV pp65 Ag Number Analyzed 65 participants
510.00
(258.00 to 813.00)
17.Primary Outcome
Title CMV-specific CD4 T-cell Frequencies
Hide Description Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 59
Median (Inter-Quartile Range)
Unit of Measure: CMV-specific CD4 T cells/million T-cells
HCMV IE1 Ag Number Analyzed 58 participants
261.00
(130.00 to 555.00)
HCMV gB Ag Number Analyzed 59 participants
830.00
(292.00 to 4407.00)
HCMV lysate Ag Number Analyzed 58 participants
2330.00
(1314.00 to 3724.00)
HCMV pp65 Ag Number Analyzed 59 participants
455.00
(236.00 to 761.00)
18.Primary Outcome
Title CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
Hide Description Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: CMV-specific CD8 T cells/million Tcells
HCMV IE1 Ag Number Analyzed 64 participants
1448.00
(496.50 to 7890.00)
HCMV gB Ag Number Analyzed 64 participants
274.00
(88.00 to 770.50)
HCMV lysate Ag Number Analyzed 64 participants
30.50
(1.00 to 122.00)
HCMV pp65 Ag Number Analyzed 65 participants
1030.00
(243.00 to 2043.00)
19.Primary Outcome
Title CMV-specific CD8 T-cell Frequencies
Hide Description Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 59
Median (Inter-Quartile Range)
Unit of Measure: CMV-specific CD8 T cells/million T-cells
HCMV IE1 Ag Number Analyzed 58 participants
2519.00
(548.00 to 9135.00)
HCMV gB Ag Number Analyzed 59 participants
209.00
(57.00 to 806.00)
HCMV lysate Ag Number Analyzed 58 participants
34.50
(1.0 to 122.00)
HCMV pp65 Ag Number Analyzed 59 participants
1054.00
(550.00 to 1931.00)
20.Primary Outcome
Title CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
Hide Description Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 61
Median (Inter-Quartile Range)
Unit of Measure: CMV-specific CD4 Tcells/million T-cells
HCMV IE1 Ag Number Analyzed 60 participants
-0.00
(-0.22 to 0.12)
HCMV gB Ag Number Analyzed 60 participants
0.61
(0.21 to 1.33)
HCMV lysate Ag Number Analyzed 56 participants
4.37
(1.69 to 10.67)
HCMV pp65 Ag Number Analyzed 61 participants
0.07
(-0.09 to 0.26)
21.Primary Outcome
Title CMV-specific Proliferating CD4 T Cells Frequencies
Hide Description

Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).

Note: Results were retrieved by subtracting the background without imputing the negative and zero values, this generated negative values.

Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 52
Median (Inter-Quartile Range)
Unit of Measure: CMV-specific CD4 T cells/million T-cells
HCMV IE1 Ag
-0.04
(-0.19 to 0.06)
HCMV gB Ag
0.53
(0.16 to 1.93)
HCMV lysate Ag
4.02
(2.49 to 13.43)
HCMV pp65 Ag
0.06
(-0.08 to 0.36)
22.Primary Outcome
Title Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies
Hide Description Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame At Day 0 = study entry
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 69
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
4.3
(3.6 to 5.2)
23.Primary Outcome
Title Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations
Hide Description Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
4.4
(3.5 to 5.5)
24.Primary Outcome
Title Concentrations of Anti-CMV Tegument Protein IgG Antibodies
Hide Description Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame At Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
4.3
(3.0 to 6.3)
25.Primary Outcome
Title Anti-CMV Tegument Protein IgG Antibody Concentrations
Hide Description Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
8.5
(6.3 to 11.6)
26.Primary Outcome
Title Concentrations of Anti-CMV IgG Antibodies
Hide Description Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
4.7
(3.9 to 5.5)
27.Primary Outcome
Title Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Hide Description Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame At Day 0 = study entry
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: Percentage (avidity index)
23.000
(12.000 to 35.000)
28.Primary Outcome
Title Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Hide Description Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: Percentage (avidity index)
24.500
(16.500 to 40.500)
29.Primary Outcome
Title Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status
Hide Description Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame At Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: Percentage (avidity index)
28.000
(22.000 to 44.500)
30.Primary Outcome
Title Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status
Hide Description Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: Percentage (avidity index)
46.000
(29.500 to 50.500)
31.Primary Outcome
Title Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status
Hide Description Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: Percentage (avidity index)
31.000
(18.000 to 44.000)
32.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 68
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
282.5
(199.6 to 400.0)
33.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
456.9
(342.0 to 610.4)
34.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame At Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
422.9
(308.1 to 580.7)
35.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
550.3
(266.4 to 1136.8)
36.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
583.9
(491.1 to 694.3)
37.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 68
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
822.5
(642.5 to 1053.0)
38.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
986.3
(746.2 to 1303.6)
39.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Time Frame At Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
1147.6
(832.8 to 1581.4)
40.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
2137.1
(675.4 to 6762.2)
41.Primary Outcome
Title Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.
Arm/Group Title CMV Mothers' Group
Hide Arm/Group Description:
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
Overall Number of Participants Analyzed 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
1100.2
(898.8 to 1346.7)
Time Frame Serious adverse events were reported during the entire study period (From Day 0 to pregnancy conclusion).
Adverse Event Reporting Description Only serious adverse events were collected in the study.
 
Arm/Group Title CMV Mothers' Group CMV Newborns' Group
Hide Arm/Group Description Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection. Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
All-Cause Mortality
CMV Mothers' Group CMV Newborns' Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   1/78 (1.28%) 
Hide Serious Adverse Events
CMV Mothers' Group CMV Newborns' Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   1/78 (1.28%) 
General disorders     
Death neonatal  1  0/77 (0.00%)  1/78 (1.28%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CMV Mothers' Group CMV Newborns' Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01251744    
Other Study ID Numbers: 113134
First Submitted: November 30, 2010
First Posted: December 2, 2010
Results First Submitted: June 9, 2017
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020