Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT00311493
Status:
COMPLETED
Last Update Posted:
2007-03-13
First Post:
2006-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004675', 'term': 'Encephalitis, Tick-Borne'}], 'ancestors': [{'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'lastUpdateSubmitDate': '2007-03-12', 'studyFirstSubmitDate': '2006-04-03', 'studyFirstSubmitQcDate': '2006-04-03', 'lastUpdatePostDateStruct': {'date': '2007-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.'}], 'secondaryOutcomes': [{'measure': 'Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization.'}]}, 'conditionsModule': {'keywords': ['TBE', 'vaccine', 'adults'], 'conditions': ['Encephalitis, Tick-Borne']}, 'descriptionModule': {'briefSummary': 'The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers of both sexes aged \\>18 who participated in another study on TBE vaccination\n\nExclusion Criteria:\n\n* Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.'}, 'identificationModule': {'nctId': 'NCT00311493', 'briefTitle': 'Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase IV, Randomized, Open-Label, Multi-Center Study in Adults: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer) in Study V48P2E1, 5 Years After First Booster Immunization and Evaluation of Booster Kinetics in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer), 5 Years After First Booster Immunization', 'orgStudyIdInfo': {'id': 'V48P2E3'}, 'secondaryIdInfos': [{'id': '498'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Tick-Borne Encephalitis vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Regensburg', 'country': 'Germany', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Drug Information Services', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chiron Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}]}}}