Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-24 @ 2:09 PM
Study NCT ID:
NCT02712359
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2016-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
This Study Will Evaluate the Persistence of Hepatitis A Antibodies, 8 Years and 10 Years Later, in Children Who Had Received Havrix at Selected Health Centres of Panama
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@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': 'SAEs: Epoch 001: from Visit at Year 8 (the time of sample collection) up to study conclusion (i.e. during an approximate period of 15 months); Epoch 002: from Visit at Year 10 (the time of sample collection) up to study conclusion (i.e. during an approximate period of 8 months).', 'description': 'Only SAEs related to study procedures were collected during the entire study period.\n\nThere were no other adverse events (AEs) data collected during the entire study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Havrix 1 dose_Year 8 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 300, 'otherNumAffected': 0, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Havrix 2 doses_Year 8 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 300, 'otherNumAffected': 0, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Havrix 1 dose_Year 10 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 299, 'otherNumAffected': 0, 'seriousNumAtRisk': 299, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Havrix 2 doses_Year 10 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 300, 'otherNumAffected': 0, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Havrix 1 dose_Year 8 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}, {'id': 'OG001', 'title': 'Havrix 2 doses_Year 8 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}], 'classes': [{'categories': [{'title': 'Seropositive', 'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}, {'title': 'Seronegative', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At approximately 8 years after the last administered vaccine dose', 'description': 'Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Havrix 1 dose_Year 10 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}, {'id': 'OG001', 'title': 'Havrix 2 doses_Year 10 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}], 'classes': [{'categories': [{'title': 'Seropositive', 'measurements': [{'value': '215', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}, {'title': 'Seronegative', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At approximately 10 years after the last administered vaccine dose', 'description': 'Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.'}, {'type': 'SECONDARY', 'title': 'Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Havrix 1 dose_Year 8 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}, {'id': 'OG001', 'title': 'Havrix 2 doses_Year 8 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000', 'lowerLimit': '34.2', 'upperLimit': '47.4'}, {'value': '123.9', 'groupId': 'OG001', 'lowerLimit': '111.5', 'upperLimit': '137.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At approximately 8 years after the last administered vaccine dose', 'description': 'Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.'}, {'type': 'SECONDARY', 'title': 'Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Havrix 1 dose_Year 10 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}, {'id': 'OG001', 'title': 'Havrix 2 doses_Year 10 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '29.5'}, {'value': '82.1', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '92.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At approximately 10 years after the last administered vaccine dose', 'description': 'Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-HAV Antibody Concentration ≥ 15 mIU/mL at Approximately 8 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Havrix 1 dose_Year 8 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}, {'id': 'OG001', 'title': 'Havrix 2 doses_Year 8 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in seropositivity rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.33', 'ciLowerLimit': '-28.78', 'ciUpperLimit': '-18.29', 'groupDescription': 'Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\\_Year 8 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\\_Year 8 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 8 years after the administration of the last vaccine dose.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\\_Year 8 Group minus Havrix 2 doses\\_Year 8 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At approximately 8 years after the last administered vaccine dose', 'description': 'Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-HAV Antibody Concentrations ≥ 15 mIU/mL at Approximately 10 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Havrix 1 dose_Year 10 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}, {'id': 'OG001', 'title': 'Havrix 2 doses_Year 10 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in seropositivity rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.43', 'ciLowerLimit': '-30.11', 'ciUpperLimit': '-19.03', 'groupDescription': 'Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\\_Year 10 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\\_Year 10 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 10 years after the administration of the last vaccine dose.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\\_Year 10 Group minus Havrix 2 doses\\_Year 10 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At approximately 10 years after the last administered vaccine dose', 'description': 'Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Havrix 1 dose_Year 8 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}, {'id': 'FG001', 'title': 'Havrix 2 doses_Year 8 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}, {'id': 'FG002', 'title': 'Havrix 1 dose_Year 10 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}, {'id': 'FG003', 'title': 'Havrix 2 doses_Year 10 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}], 'periods': [{'title': 'Epoch 001: Persistence at Year 8', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '300'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '300'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Epoch 002: Persistence at Year 10', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '299'}, {'groupId': 'FG003', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '299'}, {'groupId': 'FG003', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 4 centers in Panama. Out of the 1201 subjects originally enrolled in the study, 2 subjects were eliminated from the ATP cohort for persistence, due to non-eligibility. Hence, 1199 subjects were included in the ATP cohort for persistence.', 'preAssignmentDetails': 'The design of the study included 2 epochs: Epoch 001 - Persistence at Year 8 and Epoch 002 - Persistence at Year 10.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}, {'value': '1199', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Havrix 1 dose_Year 8 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}, {'id': 'BG001', 'title': 'Havrix 2 doses_Year 8 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.'}, {'id': 'BG002', 'title': 'Havrix 1 dose_Year 10 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}, {'id': 'BG003', 'title': 'Havrix 2 doses_Year 10 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '600', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '10.0', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '10.2', 'spread': '0.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Age continuous data for Epoch 001: Persistence at Year 8', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The age continuous data in this baseline measure are reported for Havrix 1 dose\\_Year 8 and Havrix 2 doses\\_Year 8 Groups.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}, {'value': '599', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '12.0', 'spread': '0.4', 'groupId': 'BG003'}, {'value': '12.0', 'spread': '0.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Age continuous data for Epoch 002: Persistence at Year 10', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The age continuous data in this baseline measure are reported for Havrix 1 dose\\_Year 10 and Havrix 2 doses\\_Year 10 Groups.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '600', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '296', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '304', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex: Female, Male data for Epoch 001: Persistence at Year 8', 'unitOfMeasure': 'Participants', 'populationDescription': 'The sex: female, male data in this baseline measure are reported for Havrix 1 dose\\_Year 8 and Havrix 2 doses\\_Year 8 Groups.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}, {'value': '599', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '323', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}, {'value': '276', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex: female, male data for Epoch 002: Persistence at Year 10', 'unitOfMeasure': 'Participants', 'populationDescription': 'The sex: female, male data in this baseline measure are reported for Havrix 1 dose\\_Year 10 and Havrix 2 doses\\_Year 10 Groups.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Geographic Ancestry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '600', 'groupId': 'BG004'}]}], 'categories': [{'title': 'African Heritage / African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'White - Caucasian / European Heritage', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Mixed Race', 'measurements': [{'value': '286', 'groupId': 'BG000'}, {'value': '294', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '580', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race/Ethnicity data for Epoch 001: Persistence at Year 8', 'unitOfMeasure': 'Participants', 'populationDescription': 'The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\\_Year 8 and Havrix 2 doses\\_Year 8 Groups.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Geographic ancestry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}, {'value': '599', 'groupId': 'BG004'}]}], 'categories': [{'title': 'African Heritage / African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'White - Caucasian / European Heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Mixed race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}, {'value': '577', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race/ethnicity data for Epoch 002: Persistence at Year 10', 'unitOfMeasure': 'Participants', 'populationDescription': 'The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\\_Year 10 and Havrix 2 doses\\_Year 10 Groups.'}], 'populationDescription': 'The demographic characteristics are presented separately for each study epoch (Epoch 001: Persistence at Year 8 and Epoch 002: Persistence at Year 10).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-29', 'size': 340308, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-21T15:20', 'hasProtocol': False}, {'date': '2017-07-24', 'size': 2545703, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-21T15:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-05', 'studyFirstSubmitDate': '2016-03-07', 'resultsFirstSubmitDate': '2019-08-21', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-21', 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose', 'timeFrame': 'At approximately 8 years after the last administered vaccine dose', 'description': 'Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).'}, {'measure': 'Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose', 'timeFrame': 'At approximately 10 years after the last administered vaccine dose', 'description': 'Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.'}], 'secondaryOutcomes': [{'measure': 'Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose', 'timeFrame': 'At approximately 8 years after the last administered vaccine dose', 'description': 'Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.'}, {'measure': 'Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose', 'timeFrame': 'At approximately 10 years after the last administered vaccine dose', 'description': 'Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.'}, {'measure': 'Number of Subjects With Anti-HAV Antibody Concentration ≥ 15 mIU/mL at Approximately 8 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix', 'timeFrame': 'At approximately 8 years after the last administered vaccine dose', 'description': 'Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.'}, {'measure': 'Number of Subjects With Anti-HAV Antibody Concentrations ≥ 15 mIU/mL at Approximately 10 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix', 'timeFrame': 'At approximately 10 years after the last administered vaccine dose', 'description': 'Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.'}]}, 'conditionsModule': {'keywords': ['Havrix', 'Cross-sectional seroprevalence survey', 'Panama', 'Long-term persistence', 'Hepatitis'], 'conditions': ['Hepatitis A Vaccine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the persistence of hepatitis A antibodies, approximately 8 years and 10 years post vaccination with the complete series of Havrix (2 doses) and the partial series completion (1 dose).', 'detailedDescription': 'The study comprises of two independent cross-sectional surveys (Year 8 and Year 10). The first cross-sectional serosurvey will evaluate the long term persistence of immunity approximately 8 years post vaccine administration and the second cross-sectional study will evaluate long term persistence, approximately 10 years post vaccine administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects whose parent(s)/ LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written informed assent/consent obtained from the subject or subject's parent(s)/ LAR(s) of the subject.\n* Available HAV vaccination records.\n* Children who have received either 1 or two doses of Havrix at selected health centres of Panama.\n* Children with ≥ 7 years and \\< 10 years between last dose and Persistence Visit 1 (Year 8) and children ≥ 10 years and \\< 13 years between last dose and Persistence Visit 1' (Year 10).\n\nExclusion Criteria:\n\n* Child in care.\n* Subjects with history of vaccination with other hepatitis A vaccines other than Havrix.\n* Subjects with known past history of hepatitis A infection, both without vaccination and after they received the last dose of Havrix (1 dose or the complete 2 dose schedule)."}, 'identificationModule': {'nctId': 'NCT02712359', 'briefTitle': 'This Study Will Evaluate the Persistence of Hepatitis A Antibodies, 8 Years and 10 Years Later, in Children Who Had Received Havrix at Selected Health Centres of Panama', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Long Term Hepatitis A Virus (HAV) Antibody Persistence in Children Vaccinated With 1 Dose and Those Vaccinated With 2 Doses of Havrix in Panama', 'orgStudyIdInfo': {'id': '201630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Havrix 1 dose_Year 8 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.', 'interventionNames': ['Other: Blood sample collection']}, {'type': 'OTHER', 'label': 'Havrix 2 doses_Year 8 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.', 'interventionNames': ['Other: Blood sample collection']}, {'type': 'OTHER', 'label': 'Havrix 1 dose_Year 10 Group', 'description': 'Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.', 'interventionNames': ['Other: Blood sample collection']}, {'type': 'OTHER', 'label': 'Havrix 2 doses_Year 10 Group', 'description': 'Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.', 'interventionNames': ['Other: Blood sample collection']}], 'interventions': [{'name': 'Blood sample collection', 'type': 'OTHER', 'description': 'A blood sample (\\~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).', 'armGroupLabels': ['Havrix 1 dose_Year 10 Group', 'Havrix 1 dose_Year 8 Group', 'Havrix 2 doses_Year 10 Group', 'Havrix 2 doses_Year 8 Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiriquí', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.39707, 'lon': -82.32162}}, {'city': 'Juán Diaz', 'country': 'Panama', 'facility': 'GSK Investigational Site'}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints of the study', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}