Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT00498303
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2007-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2008-04-21', 'studyFirstSubmitDate': '2007-07-09', 'studyFirstSubmitQcDate': '2007-07-09', 'lastUpdatePostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21'}, {'measure': 'evaluate safety of trivalent split influenza vaccine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['influenza vaccine'], 'conditions': ['Seasonal Influenza', 'Vaccine']}, 'descriptionModule': {'briefSummary': 'Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry\n* available for all the visits scheduled in the study and able to comply with all study requirements\n* in good health as determined by: medical history, physical examination, clinical judgment of the investigator\n\nExclusion Criteria:\n\n* n/a'}, 'identificationModule': {'nctId': 'NCT00498303', 'briefTitle': 'Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Multicenter, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2007/2008 When Administered to Adult and Elderly Subjects', 'orgStudyIdInfo': {'id': 'V44P11S'}, 'secondaryIdInfos': [{'id': '2007-001403-38'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'trivalent split influenza vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35745', 'city': 'Herborn', 'country': 'Germany', 'facility': 'Werksarztzentrum Herborn', 'geoPoint': {'lat': 50.68135, 'lon': 8.30369}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}]}}}