Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT01691820
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Adolescent Females to Explore Cytomegalovirus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D059349', 'term': 'Urine Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'biliana.v.nestorova@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events were collected throughout the entire study, from Month 0 up to Month 36.', 'description': 'There were no Other (Not Including Serious) Adverse Events collected in this study, as there were no vaccines administered.', 'eventGroups': [{'id': 'EG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged 10-17 years at enrollment in the study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 210, 'otherNumAffected': 0, 'seriousNumAtRisk': 210, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group S-', 'description': 'CMV seronegative subjects aged 10-17 years at enrollment in the study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': 'anti-Teg IgG - Two-fold and above increases', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'anti-Teg IgG -Four-fold and above increases', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 4', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrolment in the study.'}], 'classes': [{'title': 'Two-fold and above increases', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Four-fold and above increases', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 8', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrolment in the study.'}], 'classes': [{'title': 'Two-fold and above increases', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Four-fold and above increases', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 12', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': 'Two-fold and above increases', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Four-fold and above increases', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 16', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': 'Two-fold and above increases', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Four-fold and above increases', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 20', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': 'Two-fold and above increases', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Four-fold and above increases', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 24', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': 'Two-fold and above increases', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Four-fold and above increases', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 28', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': 'Two-fold and above increases', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Four-fold and above increases', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 32', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': 'Two-fold and above increases', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Four-fold and above increases', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 36', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '6.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 0', 'description': '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.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects, aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '72.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 4', 'description': '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).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '38.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 8', 'description': '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).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '34.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 12', 'description': '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).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects, aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'comment': 'No Upper or Lower limits could be computed since there was only 1 subject who met the criterion.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 16', 'description': '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).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects, aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '27.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 20', 'description': '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).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '16.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 24', 'description': '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).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects, aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '28.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 28', 'description': '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)', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'comment': 'No Upper or Lower limits could be computed since there was only 1 subject who met the criterion.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 32', 'description': '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).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '23.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 36', 'description': '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).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': '> 0 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '754.1', 'groupId': 'OG000', 'lowerLimit': '144.6', 'upperLimit': '3932.9'}]}]}, {'title': '≥ 6720 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8310.0', 'comment': 'No Upper or Lower limits could be computed since there was only 1 subject in this category.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 4', 'description': '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").', 'unitOfMeasure': 'DNA copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CCMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': '> 0 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '361.5', 'groupId': 'OG000', 'lowerLimit': '166.9', 'upperLimit': '783.3'}]}]}, {'title': '≥ 6720 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15386.0', 'comment': 'No Upper or Lower limits could be computed since there was only 1 subject in this category.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 8', 'description': '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").', 'unitOfMeasure': 'DNA copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '647.4', 'groupId': 'OG000', 'lowerLimit': '213.1', 'upperLimit': '1966.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 12', 'description': '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").', 'unitOfMeasure': 'DNA copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'PRIMARY', 'title': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '348.7', 'groupId': 'OG000', 'lowerLimit': '129.8', 'upperLimit': '936.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 16', 'description': '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").', 'unitOfMeasure': 'DNA copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'PRIMARY', 'title': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '199.4', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '408.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 20', 'description': '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").', 'unitOfMeasure': 'DNA copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'PRIMARY', 'title': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '322.1', 'groupId': 'OG000', 'lowerLimit': '112.8', 'upperLimit': '919.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 24', 'description': '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").', 'unitOfMeasure': 'DNA copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'PRIMARY', 'title': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': '> 0 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '421.9', 'groupId': 'OG000', 'lowerLimit': '71.3', 'upperLimit': '2497.2'}]}]}, {'title': '≥ 6720 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7369.0', 'comment': 'No Upper or Lower limits could be computed since there was only 1 subject in this category.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 28', 'description': '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").', 'unitOfMeasure': 'DNA copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'PRIMARY', 'title': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '186.1', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '2308.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 32', 'description': '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").', 'unitOfMeasure': 'DNA copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'PRIMARY', 'title': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects aged between 10-17 years at enrollment in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '915.3', 'groupId': 'OG000', 'lowerLimit': '123.0', 'upperLimit': '6808.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 36', 'description': '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").', 'unitOfMeasure': 'DNA copies/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S-', 'description': 'CMV seronegative subjects, aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': 'Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Month 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study Month 0 to Month 36', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group S-', 'description': 'CMV seronegative subjects, aged between 10-17 years at enrollment in the study.'}], 'classes': [{'title': 'Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.4'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '7.2'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '9.0'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '6.7'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '9.8'}]}]}, {'title': 'Month 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '9.3'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '5.0'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '8.4'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '7.1'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '9.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From study Month 0 to Month 36', 'description': '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.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group S+', 'description': 'Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.'}, {'id': 'FG001', 'title': 'Group S-', 'description': 'Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Consent withdrawal (not due to an AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Other (unspecified)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group S+', 'description': 'CMV seropositive subjects, aged 10-17 years at enrollment in the study.'}, {'id': 'BG001', 'title': 'Group S-', 'description': 'CMV seronegative subjects, aged 10-17 years at enrollment in the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '13.4', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '13.5', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African Heritage / African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic / North African Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White - Caucasian / European Heritage', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The primary and secondary objectives of this study have assessed the incidence of CMV infections in adolescent females only, hence no demographic data was collected for the 6 newborns.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-02-19', 'size': 856441, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-05T02:02', 'hasProtocol': True}, {'date': '2018-02-21', 'size': 495434, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-05T02:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2017-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-01', 'studyFirstSubmitDate': '2012-09-13', 'resultsFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-18', 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'At Month 4', 'description': '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.'}, {'measure': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'At Month 8', 'description': '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.'}, {'measure': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'At Month 12', 'description': '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.'}, {'measure': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'At Month 16', 'description': '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.'}, {'measure': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'At Month 20', 'description': '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.'}, {'measure': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'At Month 24', 'description': '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.'}, {'measure': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'At Month 28', 'description': '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.'}, {'measure': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'At Month 32', 'description': '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.'}, {'measure': 'Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'At Month 36', 'description': '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.'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 0', 'description': '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.'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 4', 'description': '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).'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 8', 'description': '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).'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 12', 'description': '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).'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 16', 'description': '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).'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 20', 'description': '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).'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 24', 'description': '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).'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 28', 'description': '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)'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 32', 'description': '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).'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).', 'timeFrame': 'At Month 36', 'description': '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).'}, {'measure': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine', 'timeFrame': 'At Month 4', 'description': '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").'}, {'measure': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'timeFrame': 'At Month 8', 'description': '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").'}, {'measure': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'timeFrame': 'At Month 12', 'description': '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").'}, {'measure': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'timeFrame': 'At Month 16', 'description': '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").'}, {'measure': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'timeFrame': 'At Month 20', 'description': '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").'}, {'measure': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'timeFrame': 'At Month 24', 'description': '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").'}, {'measure': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'timeFrame': 'At Month 28', 'description': '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").'}, {'measure': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'timeFrame': 'At Month 32', 'description': '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").'}, {'measure': 'Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine', 'timeFrame': 'At Month 36', 'description': '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").'}], 'secondaryOutcomes': [{'measure': 'Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.', 'timeFrame': 'From study Month 0 to Month 36', 'description': '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.'}, {'measure': 'Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects', 'timeFrame': 'From study Month 0 to Month 36', 'description': '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.'}]}, 'conditionsModule': {'keywords': ['Adolescent females', 'Cytomegalovirus (CMV)'], 'conditions': ['Infections, Cytomegalovirus']}, 'referencesModule': {'references': [{'pmid': '37340664', 'type': 'DERIVED', 'citation': "Paris R, Apter D, Boppana S, D'Aloia M, De Schrevel N, Delroisse JM, Grassano L, Guignard A, Panackal AA, Roman F, Yu J, Yunes EM, Dieussaert I. Incidence of Cytomegalovirus Primary and Secondary Infection in Adolescent Girls: Results From a Prospective Study. J Infect Dis. 2023 Nov 28;228(11):1491-1495. doi: 10.1093/infdis/jiad182."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary infections (re-infections/re-activations) and the incidence of CMV primary infections in adolescent females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A female adolescent between, and including 10 and 17 years at the time of enrolment regardless of pregnancy status and contraception method used or not used.\n* Subjects who the investigator believes that the subject and/or the subject's parent(s)/Legally Acceptable Representative(s) (LAR\\[s\\]) can and will comply with the requirements of the protocol.\n* Written informed assent and/or consent obtained from the subject and/or the parent(s)/LAR(s) of the subject.\n* Subject is likely to remain in the area and/or return for required study Site Visits and complete Sample Collection Visits.\n\nExclusion Criteria:\n\n* Child in care.\n* Use or planned use of any investigational or non-registered antiviral drug or vaccine during the study period.\n* Known medical history of any recurrent clinical herpes episodes requiring episodic or chronic suppressive treatment with oral or parenteral antiviral treatment such as acyclovir, famciclovir, valacyclovir or any other anti-herpes virus anti-viral during the year preceding enrolment. Topical anti-viral are allowed.\n* Subjects with history of previous vaccination against CMV.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to Visit 1 or planned administration during the study. Inhaled and topical steroids are allowed.\n* Administration of immunoglobulins and/or any blood products within 3 months prior to Visit 1 or planned administration during the study.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition including HIV-infection, based on medical history and physical examination (no laboratory testing required).\n* Any major congenital defects, serious chronic illness or organ transplantation."}, 'identificationModule': {'nctId': 'NCT01691820', 'briefTitle': 'A Study in Adolescent Females to Explore Cytomegalovirus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study in Adolescent Females to Explore Cytomegalovirus Infection', 'orgStudyIdInfo': {'id': '115639'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group S+', 'description': 'Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.', 'interventionNames': ['Procedure: Blood collection', 'Procedure: Urine collection', 'Procedure: Saliva collection']}, {'type': 'EXPERIMENTAL', 'label': 'Group S-', 'description': 'Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.', 'interventionNames': ['Procedure: Blood collection', 'Procedure: Urine collection', 'Procedure: Saliva collection']}, {'type': 'EXPERIMENTAL', 'label': 'Missing serostatus Group', 'description': 'Subjects with no confirmed serostatus, aged between 10-17 years at enrollment in the study.', 'interventionNames': ['Procedure: Blood collection', 'Procedure: Urine collection', 'Procedure: Saliva collection']}], 'interventions': [{'name': 'Blood collection', 'type': 'PROCEDURE', 'description': 'Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.', 'armGroupLabels': ['Group S+', 'Group S-', 'Missing serostatus Group']}, {'name': 'Urine collection', 'type': 'PROCEDURE', 'description': 'Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.', 'armGroupLabels': ['Group S+', 'Group S-', 'Missing serostatus Group']}, {'name': 'Saliva collection', 'type': 'PROCEDURE', 'description': 'Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.', 'armGroupLabels': ['Group S+', 'Group S-', 'Missing serostatus Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '49127', 'city': 'Stevensville', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.01449, 'lon': -86.51947}}, {'zip': '00260', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '62900', 'city': 'Jojutla', 'state': 'Morelos', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.61472, 'lon': -99.18028}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}