Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-28 @ 11:33 PM
Study NCT ID:
NCT03294135
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2017-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, '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': 'Serious adverse events that led to withdrawal or were related to study vaccination were collected throughout the study period (Year 11 to Year 15). Other serious adverse events were collected only after the booster vaccination administration (Day 0-Day 21).', 'description': 'Other adverse events were not collected as per protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Death due to glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death due to primary COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 11', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Per Protocol set-1 (PPS-1) which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 12', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 13', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 14', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '85.7', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 15', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'title': '25 to 49 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '368.8', 'groupId': 'OG000', 'lowerLimit': '208.9', 'upperLimit': '651.1'}, {'value': '301.5', 'groupId': 'OG001', 'lowerLimit': '168.7', 'upperLimit': '538.7'}, {'value': '235.2', 'groupId': 'OG002', 'lowerLimit': '161.6', 'upperLimit': '342.3'}]}]}, {'title': '>=50 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '129.6', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '218.8'}, {'value': '177.4', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '314.9'}, {'value': '128.1', 'groupId': 'OG002', 'lowerLimit': '87.7', 'upperLimit': '187.0'}]}]}, {'title': '>=60 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '127.5', 'groupId': 'OG000', 'lowerLimit': '61.3', 'upperLimit': '265.4'}, {'value': '160.2', 'groupId': 'OG001', 'lowerLimit': '79.2', 'upperLimit': '324.0'}, {'value': '103.0', 'groupId': 'OG002', 'lowerLimit': '62.6', 'upperLimit': '169.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 11', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 11. GMTs were assessed for following age subgroups: 25 to 49 years, equal to or above (\\>=) 50 years and \\>= 60 years.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'title': '25 to 49 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '323.7', 'groupId': 'OG000', 'lowerLimit': '185.0', 'upperLimit': '566.3'}, {'value': '334.6', 'groupId': 'OG001', 'lowerLimit': '184.6', 'upperLimit': '606.4'}, {'value': '264.3', 'groupId': 'OG002', 'lowerLimit': '179.9', 'upperLimit': '388.3'}]}]}, {'title': '>=50 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '154.5', 'groupId': 'OG000', 'lowerLimit': '87.6', 'upperLimit': '272.4'}, {'value': '205.8', 'groupId': 'OG001', 'lowerLimit': '110.6', 'upperLimit': '383.0'}, {'value': '158.2', 'groupId': 'OG002', 'lowerLimit': '105.0', 'upperLimit': '238.3'}]}]}, {'title': '>=60 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '133.6', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '285.6'}, {'value': '190.8', 'groupId': 'OG001', 'lowerLimit': '92.0', 'upperLimit': '395.9'}, {'value': '141.0', 'groupId': 'OG002', 'lowerLimit': '84.2', 'upperLimit': '236.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 12', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 12. GMTs were assessed for following age subgroups: 25 to 49 years, \\>= 50 years and \\>= 60 years.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'title': '25 to 49 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '196.9', 'groupId': 'OG000', 'lowerLimit': '112.2', 'upperLimit': '345.6'}, {'value': '238.4', 'groupId': 'OG001', 'lowerLimit': '131.1', 'upperLimit': '433.6'}, {'value': '172.8', 'groupId': 'OG002', 'lowerLimit': '117.3', 'upperLimit': '254.3'}]}]}, {'title': '>=50 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '56.6', 'upperLimit': '170.9'}, {'value': '132.1', 'groupId': 'OG001', 'lowerLimit': '73.0', 'upperLimit': '238.9'}, {'value': '110.9', 'groupId': 'OG002', 'lowerLimit': '75.0', 'upperLimit': '164.0'}]}]}, {'title': '>=60 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '44.7', 'upperLimit': '195.6'}, {'value': '114.8', 'groupId': 'OG001', 'lowerLimit': '56.5', 'upperLimit': '233.4'}, {'value': '96.9', 'groupId': 'OG002', 'lowerLimit': '58.7', 'upperLimit': '160.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 13', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 13. GMTs were assessed for following age subgroups: 25 to 49 years, \\>= 50 years and \\>= 60 years.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'title': '25 to 49 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '299.7', 'groupId': 'OG000', 'lowerLimit': '164.2', 'upperLimit': '547.0'}, {'value': '299.1', 'groupId': 'OG001', 'lowerLimit': '157.8', 'upperLimit': '567.1'}, {'value': '248.2', 'groupId': 'OG002', 'lowerLimit': '164.1', 'upperLimit': '375.4'}]}]}, {'title': '>=50 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '147.5', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '268.0'}, {'value': '169.7', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '321.8'}, {'value': '131.1', 'groupId': 'OG002', 'lowerLimit': '86.0', 'upperLimit': '200.0'}]}]}, {'title': '>=60 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '139.4', 'groupId': 'OG000', 'lowerLimit': '67.2', 'upperLimit': '289.3'}, {'value': '149.9', 'groupId': 'OG001', 'lowerLimit': '74.3', 'upperLimit': '302.4'}, {'value': '117.9', 'groupId': 'OG002', 'lowerLimit': '71.8', 'upperLimit': '193.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 14', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 14. GMTs were assessed for following age subgroups: 25 to 49 years, \\>= 50 years and \\>= 60 years.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'title': '25 to 49 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '217.6', 'groupId': 'OG000', 'lowerLimit': '125.2', 'upperLimit': '378.2'}, {'value': '281.6', 'groupId': 'OG001', 'lowerLimit': '156.5', 'upperLimit': '506.9'}, {'value': '183.9', 'groupId': 'OG002', 'lowerLimit': '125.7', 'upperLimit': '268.9'}]}]}, {'title': '>=50 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '54.4', 'upperLimit': '180.0'}, {'value': '157.0', 'groupId': 'OG001', 'lowerLimit': '83.8', 'upperLimit': '294.1'}, {'value': '103.3', 'groupId': 'OG002', 'lowerLimit': '67.9', 'upperLimit': '156.9'}]}]}, {'title': '>=60 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '114.1', 'groupId': 'OG000', 'lowerLimit': '52.5', 'upperLimit': '247.8'}, {'value': '158.1', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '322.7'}, {'value': '90.7', 'groupId': 'OG002', 'lowerLimit': '54.2', 'upperLimit': '151.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 15', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 15. GMTs were assessed for following age subgroups: 25 to 49 years, \\>= 50 years and \\>= 60 years.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 2 and Equal to or Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'timeFrame': 'At 21 days after the booster vaccination', 'description': 'Immunogenicity was planned to be measured in terms of percentage of participants with TBE Neutralizing Antibody Titers \\>= 2 and \\>= 10 at 21 days after the booster vaccination.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was planned to be performed on the PPS-2 which consisted of all participants who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed.'}, {'type': 'SECONDARY', 'title': "Geometric Mean Antibody Titers (GMTs) as Measured by GSK Biologicals' NT, Overall and by Study Group", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'timeFrame': 'At 21 days after the booster vaccination', 'description': 'Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was planned to be performed on the PPS-2 which consisted of all subjects who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed.'}, {'type': 'SECONDARY', 'title': "Geometric Mean Ratios (GMRs) Blood Draw After/Before Booster as Measured by GSK Biologicals' NT, Overall and by Study Group", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'timeFrame': 'At 21 days after the booster vaccination', 'description': 'Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was planned to be performed on the PPS-2 which consisted of all subjects who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group", 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'OG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'OG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '100'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.3', 'upperLimit': '100'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '100'}]}]}, {'title': 'Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '100'}, {'value': '97.6', 'groupId': 'OG001', 'lowerLimit': '87.1', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '100'}]}]}, {'title': 'Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '100'}]}]}, {'title': 'Year 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '100'}]}]}, {'title': 'Year 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.3', 'upperLimit': '100'}]}]}, {'title': 'Year 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.3', 'upperLimit': '100'}]}]}, {'title': 'Year 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.3', 'upperLimit': '100'}]}]}, {'title': 'Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.3', 'upperLimit': '100'}]}]}, {'title': 'Year 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}, {'title': 'Year 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000', 'lowerLimit': '88.9', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}, {'title': 'Year 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '85.7', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}, {'title': 'Year 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '85.7', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}, {'title': 'Year 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '85.7', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Year 1 up to Year 15', 'description': 'Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers \\>= 10 from Year 1 to Year 15.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis was performed on the set of subjects who completed the entire 15-year follow-up with no protocol deviations related to the persistence analysis. Here, 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Day 21 after booster vaccination', 'description': 'SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety population which included all subjects who received a booster vaccination in this study. Only one participant (from the Conventional Group) received a booster dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'FG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'FG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '194 subjects, who participated in study V48P7E2(NCT01562444), received in a parent V48P7 study one of the following primary schedules: rapid(R), conventional(C), or accelerated conventional(AC), who received a booster dose in study V48P7E1(NCT00387634) or before study V48P7E1(only R-schedule), and agreed to participate in this study, were enrolled.', 'preAssignmentDetails': 'No participant received vaccination in study V48P7E2 (NCT01562444).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.'}, {'id': 'BG001', 'title': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'BG002', 'title': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '48.8', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '48.1', 'spread': '14.5', 'groupId': 'BG002'}, {'value': '48.0', 'spread': '14.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'WHITE', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-23', 'size': 11539893, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-21T04:19', 'hasProtocol': True}, {'date': '2017-09-04', 'size': 850079, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-21T04:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All subjects will come to the yearly scheduled blood draw visit for investigation of 11 to 15 year persistence of Neutralization Test (NT) titres. Subjects who have an NT titre below 10 at one of the scheduled visits will receive a second booster dose 6 months after this visit at an unscheduled visit. Subsequent data of these subjects will be analysed separately in a subgroup.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2017-09-22', 'resultsFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-27', 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11', 'timeFrame': 'At Year 11', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period."}, {'measure': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12', 'timeFrame': 'At Year 12', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period."}, {'measure': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13', 'timeFrame': 'At Year 13', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period."}, {'measure': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14', 'timeFrame': 'At Year 14', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period."}, {'measure': 'Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15', 'timeFrame': 'At Year 15', 'description': "Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \\>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period."}, {'measure': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11', 'timeFrame': 'At Year 11', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 11. GMTs were assessed for following age subgroups: 25 to 49 years, equal to or above (\\>=) 50 years and \\>= 60 years.'}, {'measure': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12', 'timeFrame': 'At Year 12', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 12. GMTs were assessed for following age subgroups: 25 to 49 years, \\>= 50 years and \\>= 60 years.'}, {'measure': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13', 'timeFrame': 'At Year 13', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 13. GMTs were assessed for following age subgroups: 25 to 49 years, \\>= 50 years and \\>= 60 years.'}, {'measure': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14', 'timeFrame': 'At Year 14', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 14. GMTs were assessed for following age subgroups: 25 to 49 years, \\>= 50 years and \\>= 60 years.'}, {'measure': 'Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15', 'timeFrame': 'At Year 15', 'description': 'Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 15. GMTs were assessed for following age subgroups: 25 to 49 years, \\>= 50 years and \\>= 60 years.'}], 'secondaryOutcomes': [{'measure': "Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 2 and Equal to or Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group", 'timeFrame': 'At 21 days after the booster vaccination', 'description': 'Immunogenicity was planned to be measured in terms of percentage of participants with TBE Neutralizing Antibody Titers \\>= 2 and \\>= 10 at 21 days after the booster vaccination.'}, {'measure': "Geometric Mean Antibody Titers (GMTs) as Measured by GSK Biologicals' NT, Overall and by Study Group", 'timeFrame': 'At 21 days after the booster vaccination', 'description': 'Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.'}, {'measure': "Geometric Mean Ratios (GMRs) Blood Draw After/Before Booster as Measured by GSK Biologicals' NT, Overall and by Study Group", 'timeFrame': 'At 21 days after the booster vaccination', 'description': 'Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.'}, {'measure': "Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group", 'timeFrame': 'From Year 1 up to Year 15', 'description': 'Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers \\>= 10 from Year 1 to Year 15.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 to Day 21 after booster vaccination', 'description': 'SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Encepur', 'Adults', 'Long term immunogenicity', 'Tick-borne Encephalitis vaccine', 'Booster'], 'conditions': ['Virus Diseases']}, 'referencesModule': {'references': [{'pmid': '37142462', 'type': 'BACKGROUND', 'citation': 'Beran J, Lattanzi M, Costantini M, Pammolli A, Galgani I. Sustained antibody persistence for at least 15 years after a booster vaccination against tick-borne encephalitis following different primary vaccination schedules: Third 5-year follow-up. Vaccine. 2023 May 26;41(23):3518-3524. doi: 10.1016/j.vaccine.2023.04.061. Epub 2023 May 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to continue the evaluation of antibody persistence through 11 to 15 years after first booster with Tick-Borne Encephalitis (TBE) vaccine. This study will further investigate the booster response in subjects who will receive their second booster dose\\* in this study.\n\n\\* Any booster given in this study will be the second that the subject has received (with regard to the follow-up of the previous study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for all subjects:\n\n* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written informed consent obtained from the subject prior to performance of any study specific procedure.\n* Subjects who have participated in study V48P7E2 (NCT01562444) and who received in the parent V48P7 study one of the following schedules: rapid, conventional, or accelerated conventional and a booster vaccination in study V48P7E1 (NCT00387634) or before study V48P7E1 (NCT00387634) (only rapid schedule).\n\nAdditional inclusion criteria for subjects who will need a second booster dose:\n\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.\n* Female subjects of childbearing potential can receive the booster vaccine in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after booster administration.\n\nExclusion Criteria:\n\nEach subject must not be:\n\n* Unwilling or unable to give written informed consent to participate in the study.\n* Perceived to be unreliable or unavailable to complete the study.\n\nEach subject must not have:\n\n* Clinical conditions representing a contraindication to blood draws.\n* Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.\n* Received an investigational or non-registered medicinal product within 30 days prior to informed consent.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.\n* Levels of NT\\<10 in V48P7E2 (NCT01562444) study.\n* Previous vaccination against TBE or other Flavivirus diseases with other TBE and Flavivirus vaccines (e.g. Yellow fever vaccine, Dengue fever vaccine, Japanese encephalitis vaccine) before, during and after completion of the V48P7E2 (NCT01562444) and before starting TBEV POLYGELINE FREE-025 EXT 21 study.\n* Primary immunization with TBE vaccine in the parent study V48P7 according to the modified conventional (MC) schedule.\n* History of confirmed TBE infection.\n* Known exposure to other Flaviviruses.\n\nEach subject who will receive the second booster vaccination in this study additionally to the exclusion criteria above must not have:\n\n* Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.\n* Clinical conditions representing a contraindication to intramuscular vaccination.\n* Progressive, unstable or uncontrolled clinical conditions.\n* Abnormal function of the immune system resulting from: Clinical conditions. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent. This will mean prednisone ≥20 mg/day (for adult subjects) or equivalent. Inhaled and topical steroids are allowed. Administration of antineoplastic and immuno-modulating agents or radiotherapy within 90 days prior to vaccination.\n* Received immunoglobulins or any blood products within 180 days prior to vaccination.\n* Administration of long-acting immune-modifying drugs at any time during the study period.\n* Acute disease and/or fever at the day of booster vaccination.\n* Expected general decrease in immune response.\n* Organic brain disturbances, including seizure disorders.\n* Progressive neurological disorders.\n* Suffered febrile or afebrile convulsions.\n* Serious chronic illness.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or chemically related substances.\n* Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccines.\n* Pregnant.'}, 'identificationModule': {'nctId': 'NCT03294135', 'briefTitle': "The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Long Term Immunogenicity up to 15 Years After the First Booster Immunization With GSK Biologicals' Encepur Adults (Polygeline-free Tick-Borne Encephalitis Vaccine for Adults) in Adults Who Received 1 of 3 Different Primary Vaccination Schedules", 'orgStudyIdInfo': {'id': '205847'}, 'secondaryIdInfos': [{'id': '2017-001356-59', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.', 'interventionNames': ['Biological: Encepur Adults']}, {'type': 'EXPERIMENTAL', 'label': 'Accelerated/Rapid Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.', 'interventionNames': ['Biological: Encepur Adults']}, {'type': 'EXPERIMENTAL', 'label': 'Accelerated Conventional Group', 'description': 'Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.', 'interventionNames': ['Biological: Encepur Adults']}], 'interventions': [{'name': 'Encepur Adults', 'type': 'BIOLOGICAL', 'description': 'One dose of the vaccine can be administered at any one unscheduled visit depending on the detection of NT below 10. It will be administered intramuscularly into the non-dominant deltoid.', 'armGroupLabels': ['Accelerated Conventional Group', 'Accelerated/Rapid Group', 'Conventional Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50002', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}