Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT00387634
Status:
COMPLETED
Last Update Posted:
2012-11-02
First Post:
2006-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-01', 'studyFirstSubmitDate': '2006-10-11', 'studyFirstSubmitQcDate': '2006-10-11', 'lastUpdatePostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA', 'timeFrame': 'On day 21, year 1, year 2, year 3, year 4, year 5'}], 'secondaryOutcomes': [{'measure': 'safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting', 'timeFrame': 'Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study'}]}, 'conditionsModule': {'keywords': ['tick born encephalitis, TBE, adults'], 'conditions': ['Tick Born Encephalitis']}, 'referencesModule': {'references': [{'pmid': '24950352', 'type': 'DERIVED', 'citation': 'Beran J, Xie F, Zent O. Five year follow-up after a first booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates long-term antibody persistence and safety. Vaccine. 2014 Jul 23;32(34):4275-80. doi: 10.1016/j.vaccine.2014.06.028. Epub 2014 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects who have completed study V48P7\n\nExclusion Criteria:\n\n* acute illness at day of immunization\n* general decrease in resistance\n* progressive neurological disorders\n* history of febrile or afebrile convulsions\n* major congenital defects\n* serious chronic illness\n* hypersensitivity to study vaccine\n* treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates'}, 'identificationModule': {'nctId': 'NCT00387634', 'briefTitle': "Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization", 'orgStudyIdInfo': {'id': 'V48P7E1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'Blood draw only, no vaccine', 'interventionNames': ['Biological: TBE vaccine for adults']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Blood draw only, no vaccine', 'interventionNames': ['Biological: TBE vaccine for adults']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'description': 'Blood draw only, no vaccine', 'interventionNames': ['Biological: TBE vaccine for adults']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4', 'description': 'Blood draw only, no vaccine', 'interventionNames': ['Biological: TBE vaccine for adults']}], 'interventions': [{'name': 'TBE vaccine for adults', 'type': 'BIOLOGICAL', 'description': 'Serology blood draw.', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500 03', 'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}], 'overallOfficials': [{'name': 'Novartis Vaccines - Information Services', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}