Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01295320
Status:
COMPLETED
Last Update Posted:
2017-11-27
First Post:
2011-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects
Sponsor:
Organization:
Raw JSON
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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: Month 0 to Month 72', 'description': 'No Frequent Adverse events were collected during this study.', 'eventGroups': [{'id': 'EG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). 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'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114825', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114825', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114825', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114825', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114825', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114825', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity.\n\nThis long term follow up study (ZOSTER-024 \\[114825\\]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.\n\nThe study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes can and will comply with the requirements of the protocol\n* Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group\n* Written informed consent obtained from the subject\n\nExclusion Criteria:\n\n* Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product or; 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 product\n* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw\n* Having received a vaccine containing some vaccine components, any time after study end of study NCT00434577\n* Having received a vaccine against HZ any time after study end of study NCT00434577\n* Subject who did not receive a complete vaccination course of 2 doses of the intermediate dose active vaccine in study NCT00434577'}, 'identificationModule': {'nctId': 'NCT01295320', 'briefTitle': 'Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects", 'orgStudyIdInfo': {'id': '114825'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK1437173A Group', 'description': 'Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).', 'interventionNames': ['Procedure: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'PROCEDURE', 'description': 'Blood sample will be collected at Month 48, Month 60 and Month 72', 'armGroupLabels': ['GSK1437173A Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500 01', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '68161', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '97070', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '51069', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45359', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '13347', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '1018 WT', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3011 EN', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': 'SE-631 88', 'city': 'Eskilstuna', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.36661, 'lon': 16.5077}}, {'zip': 'SE-751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}