Trial Outcomes & Findings for A Study in Adolescent Females to Explore Cytomegalovirus Infection (NCT NCT01691820)
NCT ID: NCT01691820
Last Updated: 2021-04-27
Results Overview
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
COMPLETED
NA
369 participants
At Month 4
2021-04-27
Participant Flow
Enrolment was terminated once approximately 240 seropositive subjects were included in the trial, to obtain approximately 200 evaluable seropositive subjects. The number of seronegative subjects enrolled depended on the seroprevalence of the participating countries.
Of the 369 enrolled subjects, 363 were female subjects and 6 were newborns of some subjects. Consent was signed for the newborns to allow testing for CMV disease. The objectives assessed the CMV infections in the adolescent females with a known serostatus (N=362); no demographics, outcome measures, or adverse events were assessed in newborns.
Participant milestones
| Measure |
Group S+
Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.
|
Group S-
Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.
|
|---|---|---|
|
Overall Study
STARTED
|
210
|
152
|
|
Overall Study
COMPLETED
|
184
|
115
|
|
Overall Study
NOT COMPLETED
|
26
|
37
|
Reasons for withdrawal
| Measure |
Group S+
Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.
|
Group S-
Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.
|
|---|---|---|
|
Overall Study
Consent withdrawal (not due to an AE)
|
9
|
15
|
|
Overall Study
Migrated/moved from study area
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
17
|
|
Overall Study
Other (unspecified)
|
4
|
1
|
Baseline Characteristics
A Study in Adolescent Females to Explore Cytomegalovirus Infection
Baseline characteristics by cohort
| Measure |
Group S+
n=210 Participants
CMV seropositive subjects, aged 10-17 years at enrollment in the study.
|
Group S-
n=152 Participants
CMV seronegative subjects, aged 10-17 years at enrollment in the study.
|
Total
n=362 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.5 Years
STANDARD_DEVIATION 2.1 • n=99 Participants
|
13.4 Years
STANDARD_DEVIATION 2.2 • n=107 Participants
|
13.5 Years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
210 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
362 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African Heritage / African American
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African Heritage
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
64 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
137 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Month 4Population: This analysis was performed on CMV seropositive subjects with available results at Month 4 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Outcome measures
| Measure |
Group S+
n=202 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
anti-Teg IgG - Two-fold and above increases
|
5 Participants
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
anti-Teg IgG -Four-fold and above increases
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 8Population: This analysis was performed on CMV seropositive subjects with available results at Month 8 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Outcome measures
| Measure |
Group S+
n=197 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Two-fold and above increases
|
5 Participants
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Four-fold and above increases
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: This analysis was performed on CMV seropositive subjects with available results at Month 12 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Outcome measures
| Measure |
Group S+
n=198 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Two-fold and above increases
|
6 Participants
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Four-fold and above increases
|
3 Participants
|
PRIMARY outcome
Timeframe: At Month 16Population: This analysis was performed on CMV seropositive subjects with available results at Month 16 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Outcome measures
| Measure |
Group S+
n=196 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Two-fold and above increases
|
1 Participants
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Four-fold and above increases
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 20Population: This analysis was performed on CMV seropositive subjects with available results at Month 20 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Outcome measures
| Measure |
Group S+
n=191 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Two-fold and above increases
|
5 Participants
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Four-fold and above increases
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 24Population: This analysis was performed on CMV seropositive subjects with available results at Month 24 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Outcome measures
| Measure |
Group S+
n=189 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Two-fold and above increases
|
6 Participants
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Four-fold and above increases
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 28Population: This analysis was performed on CMV seropositive subjects with available results at Month 28 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Outcome measures
| Measure |
Group S+
n=188 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Two-fold and above increases
|
5 Participants
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Four-fold and above increases
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 32Population: This analysis was performed on CMV seropositive subjects with available results at Month 32 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Outcome measures
| Measure |
Group S+
n=184 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Two-fold and above increases
|
1 Participants
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Four-fold and above increases
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 36Population: This analysis was performed on CMV seropositive subjects with available results at Month 36 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Outcome measures
| Measure |
Group S+
n=180 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Two-fold and above increases
|
3 Participants
|
|
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Four-fold and above increases
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 0Population: This analysis was performed on CMV seropositive subjects with available results at Month 0 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.
Outcome measures
| Measure |
Group S+
n=206 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
5.4 EU/mL
Interval 4.9 to 6.1
|
PRIMARY outcome
Timeframe: At Month 4Population: This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 4, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases \[including four-fold\] of CMV anti-tegument IgG compared with previous time point).
Outcome measures
| Measure |
Group S+
n=5 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
32.2 EU/mL
Interval 14.4 to 72.0
|
PRIMARY outcome
Timeframe: At Month 8Population: This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 8, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases \[including four-fold\] of CMV anti-tegument IgG compared with previous time point).
Outcome measures
| Measure |
Group S+
n=5 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
10.3 EU/mL
Interval 2.8 to 38.0
|
PRIMARY outcome
Timeframe: At Month 12Population: This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 12, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases \[including four-fold\] of CMV anti-tegument IgG compared with previous time point).
Outcome measures
| Measure |
Group S+
n=6 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
9.8 EU/mL
Interval 2.7 to 34.9
|
PRIMARY outcome
Timeframe: At Month 16Population: This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 16, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases \[including four-fold\] of CMV anti-tegument IgG compared with previous time point).
Outcome measures
| Measure |
Group S+
n=1 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
26.5 EU/mL
No Upper or Lower limits could be computed since there was only 1 subject who met the criterion.
|
PRIMARY outcome
Timeframe: At Month 20Population: This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 20, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases \[including four-fold\] of CMV anti-tegument IgG compared with previous time point).
Outcome measures
| Measure |
Group S+
n=5 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
10.1 EU/mL
Interval 3.7 to 27.7
|
PRIMARY outcome
Timeframe: At Month 24Population: This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 24, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases \[including four-fold\] of CMV anti-tegument IgG compared with previous time point).
Outcome measures
| Measure |
Group S+
n=6 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
9.3 EU/mL
Interval 5.4 to 16.0
|
PRIMARY outcome
Timeframe: At Month 28Population: This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 28, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases \[including four-fold\] of CMV anti-tegument IgG compared with previous time point)
Outcome measures
| Measure |
Group S+
n=5 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
8.3 EU/mL
Interval 2.4 to 28.9
|
PRIMARY outcome
Timeframe: At Month 32Population: This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 32, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases \[including four-fold\] of CMV anti-tegument IgG compared with previous time point).
Outcome measures
| Measure |
Group S+
n=1 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
14.4 EU/mL
No Upper or Lower limits could be computed since there was only 1 subject who met the criterion.
|
PRIMARY outcome
Timeframe: At Month 36Population: This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 36, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases \[including four-fold\] of CMV anti-tegument IgG compared with previous time point).
Outcome measures
| Measure |
Group S+
n=3 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
|
6.9 EU/mL
Interval 2.0 to 23.8
|
PRIMARY outcome
Timeframe: At Month 4Population: This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 4, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for CMV seropositive subjects with appearance of CMV DNA (\>0 copies/mL) and DNA copies=0 in prior urine sample (category="\> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0\<DNA copies \<LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").
Outcome measures
| Measure |
Group S+
n=8 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine
> 0 Copies/mL
|
754.1 DNA copies/mL
Interval 144.6 to 3932.9
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine
≥ 6720 Copies/mL
|
8310.0 DNA copies/mL
No Upper or Lower limits could be computed since there was only 1 subject in this category.
|
PRIMARY outcome
Timeframe: At Month 8Population: This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 8, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (\>0 copies/mL) and DNA copies=0 in prior urine sample (category="\> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0\<DNA copies \<LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").
Outcome measures
| Measure |
Group S+
n=11 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
> 0 Copies/mL
|
361.5 DNA copies/mL
Interval 166.9 to 783.3
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
≥ 6720 Copies/mL
|
15386.0 DNA copies/mL
No Upper or Lower limits could be computed since there was only 1 subject in this category.
|
PRIMARY outcome
Timeframe: At Month 12Population: This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 12, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (\>0 copies/mL) and DNA copies=0 in prior urine sample (category="\> 0 Copies/mL").
Outcome measures
| Measure |
Group S+
n=10 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
|
647.4 DNA copies/mL
Interval 213.1 to 1966.6
|
PRIMARY outcome
Timeframe: At Month 16Population: This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 16, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (\>0 copies/mL) and DNA copies=0 in prior urine sample (category="\> 0 Copies/mL").
Outcome measures
| Measure |
Group S+
n=9 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
|
348.7 DNA copies/mL
Interval 129.8 to 936.9
|
PRIMARY outcome
Timeframe: At Month 20Population: This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 20, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (\>0 copies/mL) and DNA copies=0 in prior urine sample (category="\> 0 Copies/mL").
Outcome measures
| Measure |
Group S+
n=3 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
|
199.4 DNA copies/mL
Interval 97.5 to 408.0
|
PRIMARY outcome
Timeframe: At Month 24Population: This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 24,from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (\>0 copies/mL) and DNA copies=0 in prior urine sample (category="\> 0 Copies/mL").
Outcome measures
| Measure |
Group S+
n=8 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
|
322.1 DNA copies/mL
Interval 112.8 to 919.4
|
PRIMARY outcome
Timeframe: At Month 28Population: This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 28,from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (\>0 copies/mL) and DNA copies=0 in prior urine sample (category="\> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0\<DNA copies \<LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").
Outcome measures
| Measure |
Group S+
n=7 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
> 0 Copies/mL
|
421.9 DNA copies/mL
Interval 71.3 to 2497.2
|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
≥ 6720 Copies/mL
|
7369.0 DNA copies/mL
No Upper or Lower limits could be computed since there was only 1 subject in this category.
|
PRIMARY outcome
Timeframe: At Month 32Population: This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 32, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (\>0 copies/mL) and DNA copies=0 in prior urine sample (category="\> 0 Copies/mL").
Outcome measures
| Measure |
Group S+
n=3 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
|
186.1 DNA copies/mL
Interval 15.0 to 2308.8
|
PRIMARY outcome
Timeframe: At Month 36Population: This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 36, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures
This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (\>0 copies/mL) and DNA copies=0 in prior urine sample (category="\> 0 Copies/mL").
Outcome measures
| Measure |
Group S+
n=7 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
|
915.3 DNA copies/mL
Interval 123.0 to 6808.7
|
SECONDARY outcome
Timeframe: From study Month 0 to Month 36Population: This analysis was performed on the seronegative subjects with available results at the specified timepoints, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome was part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegative subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment.
Outcome measures
| Measure |
Group S+
n=152 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 0
|
0 Participants
|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 4
|
5 Participants
|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 8
|
5 Participants
|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 12
|
4 Participants
|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 16
|
6 Participants
|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 20
|
8 Participants
|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 24
|
12 Participants
|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 28
|
8 Participants
|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 32
|
9 Participants
|
|
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Month 36
|
12 Participants
|
SECONDARY outcome
Timeframe: From study Month 0 to Month 36Population: This analysis was performed on the seronegative subjects with available results at Month 0, or on the seronegative subjects with antibody concentration above 1.136 U/mL for the other time points, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.
This outcome is part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegatve subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.
Outcome measures
| Measure |
Group S+
n=152 Participants
CMV seropositive subjects aged between 10-17 years at enrollment in the study.
|
|---|---|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 0
|
0.4 EU/mL
Interval 0.3 to 0.4
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 4
|
2.4 EU/mL
Interval 0.8 to 7.2
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 8
|
2.6 EU/mL
Interval 0.8 to 9.0
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 12
|
1.8 EU/mL
Interval 0.5 to 6.7
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 16
|
3.5 EU/mL
Interval 1.2 to 9.8
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 20
|
4.5 EU/mL
Interval 2.2 to 9.3
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 24
|
2.7 EU/mL
Interval 1.5 to 5.0
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 28
|
3.5 EU/mL
Interval 1.4 to 8.4
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 32
|
3.4 EU/mL
Interval 1.7 to 7.1
|
|
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Month 36
|
4.5 EU/mL
Interval 2.1 to 9.6
|
Adverse Events
Group S+
Group S-
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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