Trial Outcomes & Findings for Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus (NCT NCT01251744)
NCT ID: NCT01251744
Last Updated: 2020-06-29
Results Overview
The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.
COMPLETED
NA
160 participants
At Month 0
2020-06-29
Participant Flow
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.
Participant milestones
| Measure |
CMV Mothers' Group
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
78
|
|
Overall Study
COMPLETED
|
76
|
78
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
CMV Mothers' Group
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
This analysis presents data only for the CMV Mothers' Group.
Baseline characteristics by cohort
| Measure |
CMV Mothers' Group
n=77 Participants
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
|
CMV Newborns' Group
n=78 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.4 Years
STANDARD_DEVIATION 4.8 • n=77 Participants • This analysis presents data only for the CMV Mothers' Group.
|
38.7 Weeks
STANDARD_DEVIATION 2.5 • n=78 Participants • This analysis presents data only for the CMV Newborns' Group.
|
38.7 Weeks
STANDARD_DEVIATION 2.5 • n=78 Participants • This analysis presents data only for the CMV Newborns' Group.
|
|
Sex: Female, Male
Female
|
77 Participants
n=77 Participants
|
42 Participants
n=78 Participants
|
119 Participants
n=155 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=77 Participants
|
36 Participants
n=78 Participants
|
36 Participants
n=155 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African Heritage
|
3 Participants
n=77 Participants
|
2 Participants
n=78 Participants
|
5 Participants
n=155 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
74 Participants
n=77 Participants
|
71 Participants
n=78 Participants
|
145 Participants
n=155 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
0 Participants
n=77 Participants
|
5 Participants
n=78 Participants
|
5 Participants
n=155 Participants
|
PRIMARY outcome
Timeframe: At Month 0Population: 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.
The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.
Outcome measures
| Measure |
CMV Offsprings' Group
n=82 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
n=78 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
n=4 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection
Confirmed CMV infection
|
24 Participants
|
20 Participants
|
4 Participants
|
|
Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection
Not confirmed CMV infection
|
58 Participants
|
58 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 10 days post-delivery (Days 0-9)Population: 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.
Evidence of infection in urine was assessed by culture or by Polymerase Chain Reaction (PCR).
Outcome measures
| Measure |
CMV Offsprings' Group
n=78 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Number of Subjects With CMV Presence in the Urine
Positive: PCR Not Done/Culture Positive
|
6 Participants
|
—
|
—
|
|
Number of Subjects With CMV Presence in the Urine
Positive: PCR Positive/Culture Negative
|
5 Participants
|
—
|
—
|
|
Number of Subjects With CMV Presence in the Urine
Positive: PCR Positive/Culture Not Done
|
5 Participants
|
—
|
—
|
|
Number of Subjects With CMV Presence in the Urine
Positive: PCR Positive/Culture Positive
|
4 Participants
|
—
|
—
|
|
Number of Subjects With CMV Presence in the Urine
Negative: PCR Negative/Culture Negative
|
19 Participants
|
—
|
—
|
|
Number of Subjects With CMV Presence in the Urine
Negative: PCR Negative/Culture Not Done
|
6 Participants
|
—
|
—
|
|
Number of Subjects With CMV Presence in the Urine
Negative: PCR Not Done/Culture Negative
|
32 Participants
|
—
|
—
|
|
Number of Subjects With CMV Presence in the Urine
Not Done: PCR Not Done/Culture Not Done
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 10 days post-delivery (Days 0-9)Population: 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.
Evidence of infection in the amniotic fluid was assessed by culture or by Polymerase Chain Reaction (PCR).
Outcome measures
| Measure |
CMV Offsprings' Group
n=82 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
n=78 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
n=4 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Number of Subjects With CMV Presence in the Amniotic Fluid
Positive: PCR Positive/Culture Negative
|
9 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With CMV Presence in the Amniotic Fluid
Positive: PCR Positive/Culture Positive
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With CMV Presence in the Amniotic Fluid
Negative: PCR Negative/Culture Negative
|
28 Participants
|
28 Participants
|
0 Participants
|
|
Number of Subjects With CMV Presence in the Amniotic Fluid
Negative: PCR Negative/Culture Not Done
|
9 Participants
|
9 Participants
|
0 Participants
|
|
Number of Subjects With CMV Presence in the Amniotic Fluid
Not Done: PCR Not Done/Culture Not Done
|
30 Participants
|
30 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 10 days post-delivery (Days 0-9)Population: The diagnosis of CMV in the newborn was done according to the local standard of care and samples were not collected for this analysis.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At Month 0Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=70 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
Buffy coat
|
0.000 CMV DNA copies/sample
Interval 0.0 to 0.0
|
—
|
—
|
|
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
Plasma
|
0.000 CMV DNA copies/sample
Interval 0.0 to 0.0
|
—
|
—
|
|
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
Saliva
|
0.000 CMV DNA copies/sample
Interval 0.0 to 497.0
|
—
|
—
|
|
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
Urine
|
1050.000 CMV DNA copies/sample
Interval 0.0 to 3690.0
|
—
|
—
|
|
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
Vaginal mucus
|
1950.000 CMV DNA copies/sample
Interval 280.0 to 11510.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=70 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
Buffy coat
|
0.000 CMV DNA copies/sample
Interval 0.0 to 0.0
|
—
|
—
|
|
Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
Plasma
|
0.000 CMV DNA copies/sample
Interval 0.0 to 0.0
|
—
|
—
|
|
Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
Saliva
|
0.000 CMV DNA copies/sample
Interval 0.0 to 231.5
|
—
|
—
|
|
Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
Urine
|
311.000 CMV DNA copies/sample
Interval 0.0 to 1370.0
|
—
|
—
|
|
Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
Vaginal mucus
|
1950.000 CMV DNA copies/sample
Interval 280.0 to 11510.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 0Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=69 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
Positive
|
53 Participants
|
—
|
—
|
|
Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
Negative
|
12 Participants
|
—
|
—
|
|
Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
Grey Zone
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 2Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=56 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics of the Anti-CMV IgM Status
Positive
|
27 Participants
|
—
|
—
|
|
Descriptive Statistics of the Anti-CMV IgM Status
Negative
|
24 Participants
|
—
|
—
|
|
Descriptive Statistics of the Anti-CMV IgM Status
Grey Zone
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=23 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
Positive
|
8 Participants
|
—
|
—
|
|
Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
Negative
|
13 Participants
|
—
|
—
|
|
Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
Grey Zone
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: 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.
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay \[ELISA\], with respect to positive and negative subjects.
Outcome measures
| Measure |
CMV Offsprings' Group
n=4 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics
Negative
|
3 Participants
|
—
|
—
|
|
Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics
Positive
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=64 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics for the Anti-CMV IgM Status
Positive
|
24 Participants
|
—
|
—
|
|
Descriptive Statistics for the Anti-CMV IgM Status
Negative
|
35 Participants
|
—
|
—
|
|
Descriptive Statistics for the Anti-CMV IgM Status
Grey Zone
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 0Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=69 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations
|
4460.8 EU/mL
Interval 3432.2 to 5797.6
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=64 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-gB IgG Antibody Concentrations
|
6708.2 EU/mL
Interval 5835.9 to 7711.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 0Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=70 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index
|
22.000 Percentage (avidity index)
Interval 17.0 to 35.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=70 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics of the Anti-gB IgG Avidity Index
|
36.500 Percentage (avidity index)
Interval 28.0 to 43.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 0Population: 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.
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).
Outcome measures
| Measure |
CMV Offsprings' Group
n=65 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
HCMV IE1 Ag
|
350.50 CMV-specific CD4 T cells/million T-cells
Interval 101.5 to 633.0
|
—
|
—
|
|
CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
HCMV gB Ag
|
1009.50 CMV-specific CD4 T cells/million T-cells
Interval 381.0 to 3395.0
|
—
|
—
|
|
CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
HCMV lysate Ag
|
2864.00 CMV-specific CD4 T cells/million T-cells
Interval 1396.0 to 5980.0
|
—
|
—
|
|
CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
HCMV pp65 Ag
|
510.00 CMV-specific CD4 T cells/million T-cells
Interval 258.0 to 813.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
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).
Outcome measures
| Measure |
CMV Offsprings' Group
n=59 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
CMV-specific CD4 T-cell Frequencies
HCMV IE1 Ag
|
261.00 CMV-specific CD4 T cells/million T-cells
Interval 130.0 to 555.0
|
—
|
—
|
|
CMV-specific CD4 T-cell Frequencies
HCMV gB Ag
|
830.00 CMV-specific CD4 T cells/million T-cells
Interval 292.0 to 4407.0
|
—
|
—
|
|
CMV-specific CD4 T-cell Frequencies
HCMV lysate Ag
|
2330.00 CMV-specific CD4 T cells/million T-cells
Interval 1314.0 to 3724.0
|
—
|
—
|
|
CMV-specific CD4 T-cell Frequencies
HCMV pp65 Ag
|
455.00 CMV-specific CD4 T cells/million T-cells
Interval 236.0 to 761.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 0Population: 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.
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).
Outcome measures
| Measure |
CMV Offsprings' Group
n=65 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
HCMV IE1 Ag
|
1448.00 CMV-specific CD8 T cells/million Tcells
Interval 496.5 to 7890.0
|
—
|
—
|
|
CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
HCMV gB Ag
|
274.00 CMV-specific CD8 T cells/million Tcells
Interval 88.0 to 770.5
|
—
|
—
|
|
CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
HCMV lysate Ag
|
30.50 CMV-specific CD8 T cells/million Tcells
Interval 1.0 to 122.0
|
—
|
—
|
|
CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
HCMV pp65 Ag
|
1030.00 CMV-specific CD8 T cells/million Tcells
Interval 243.0 to 2043.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
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).
Outcome measures
| Measure |
CMV Offsprings' Group
n=59 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
CMV-specific CD8 T-cell Frequencies
HCMV IE1 Ag
|
2519.00 CMV-specific CD8 T cells/million T-cells
Interval 548.0 to 9135.0
|
—
|
—
|
|
CMV-specific CD8 T-cell Frequencies
HCMV gB Ag
|
209.00 CMV-specific CD8 T cells/million T-cells
Interval 57.0 to 806.0
|
—
|
—
|
|
CMV-specific CD8 T-cell Frequencies
HCMV lysate Ag
|
34.50 CMV-specific CD8 T cells/million T-cells
Interval 1.0 to 122.0
|
—
|
—
|
|
CMV-specific CD8 T-cell Frequencies
HCMV pp65 Ag
|
1054.00 CMV-specific CD8 T cells/million T-cells
Interval 550.0 to 1931.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 0Population: 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.
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).
Outcome measures
| Measure |
CMV Offsprings' Group
n=61 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
HCMV IE1 Ag
|
-0.00 CMV-specific CD4 Tcells/million T-cells
Interval -0.22 to 0.12
|
—
|
—
|
|
CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
HCMV gB Ag
|
0.61 CMV-specific CD4 Tcells/million T-cells
Interval 0.21 to 1.33
|
—
|
—
|
|
CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
HCMV lysate Ag
|
4.37 CMV-specific CD4 Tcells/million T-cells
Interval 1.69 to 10.67
|
—
|
—
|
|
CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
HCMV pp65 Ag
|
0.07 CMV-specific CD4 Tcells/million T-cells
Interval -0.09 to 0.26
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=52 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
CMV-specific Proliferating CD4 T Cells Frequencies
HCMV IE1 Ag
|
-0.04 CMV-specific CD4 T cells/million T-cells
Interval -0.19 to 0.06
|
—
|
—
|
|
CMV-specific Proliferating CD4 T Cells Frequencies
HCMV gB Ag
|
0.53 CMV-specific CD4 T cells/million T-cells
Interval 0.16 to 1.93
|
—
|
—
|
|
CMV-specific Proliferating CD4 T Cells Frequencies
HCMV lysate Ag
|
4.02 CMV-specific CD4 T cells/million T-cells
Interval 2.49 to 13.43
|
—
|
—
|
|
CMV-specific Proliferating CD4 T Cells Frequencies
HCMV pp65 Ag
|
0.06 CMV-specific CD4 T cells/million T-cells
Interval -0.08 to 0.36
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0 = study entryPopulation: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=69 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies
|
4.8 U/mL
Interval 3.9 to 6.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 2Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=56 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations
|
4.9 U/mL
Interval 3.8 to 6.5
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=23 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Concentrations of Anti-CMV Tegument Protein IgG Antibodies
|
4.9 U/mL
Interval 3.2 to 7.5
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=4 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentrations
|
13.5 U/mL
Interval 3.9 to 46.2
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=64 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Concentrations of Anti-CMV IgG Antibodies
|
5.3 U/mL
Interval 4.3 to 6.6
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0 = study entryPopulation: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=70 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
|
23.000 Percentage (avidity index)
Interval 12.0 to 35.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 2Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=70 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
|
24.500 Percentage (avidity index)
Interval 16.5 to 40.5
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=70 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status
|
28.000 Percentage (avidity index)
Interval 22.0 to 44.5
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=70 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status
|
46.000 Percentage (avidity index)
Interval 29.5 to 50.5
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
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.
Outcome measures
| Measure |
CMV Offsprings' Group
n=70 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status
|
31.000 Percentage (avidity index)
Interval 18.0 to 44.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 0Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=68 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
|
282.5 titers
Interval 199.6 to 400.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 2Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=56 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
|
456.9 titers
Interval 342.0 to 610.4
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=23 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
|
422.9 titers
Interval 308.1 to 580.7
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=4 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
|
550.3 titers
Interval 266.4 to 1136.8
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=64 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
|
583.9 titers
Interval 491.1 to 694.3
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 0Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=68 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
|
822.5 titers
Interval 642.5 to 1053.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 2Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=56 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
|
986.3 titers
Interval 746.2 to 1303.6
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=23 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
|
1147.6 titers
Interval 832.8 to 1581.4
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=4 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
|
2137.1 titers
Interval 675.4 to 6762.2
|
—
|
—
|
PRIMARY outcome
Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)Population: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Outcome measures
| Measure |
CMV Offsprings' Group
n=64 Participants
Offsprings of the CMV Mothers' Group, also tested for CMV infection.
|
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
CMV Foetus Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
|
|---|---|---|---|
|
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
|
1100.2 titers
Interval 898.8 to 1346.7
|
—
|
—
|
Adverse Events
CMV Mothers' Group
CMV Newborns' Group
Serious adverse events
| Measure |
CMV Mothers' Group
n=77 participants at risk
Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
|
CMV Newborns' Group
n=78 participants at risk
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
|
|---|---|---|
|
General disorders
Death neonatal
|
0.00%
0/77 • Serious adverse events were reported during the entire study period (From Day 0 to pregnancy conclusion).
Only serious adverse events were collected in the study.
|
1.3%
1/78 • Serious adverse events were reported during the entire study period (From Day 0 to pregnancy conclusion).
Only serious adverse events were collected in the study.
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER