Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00735020
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
2008-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-23', 'studyFirstSubmitDate': '2008-08-13', 'studyFirstSubmitQcDate': '2008-08-13', 'lastUpdatePostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.', 'timeFrame': '36 Days'}], 'secondaryOutcomes': [{'measure': 'To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine', 'timeFrame': '36 Days'}]}, 'conditionsModule': {'keywords': ['influenza', 'vaccine', 'adjuvants', 'flu'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '21906647', 'type': 'RESULT', 'citation': 'Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment\n\nExclusion Criteria:\n\n* serious medical conditions\n* allergies to vaccine components, including but not limited to egg/chicken products\n* reduced immune function\n* recent use of immunosuppressive therapy\n* recent use of influenza vaccine'}, 'identificationModule': {'nctId': 'NCT00735020', 'briefTitle': 'Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I, Observer-Blind, Randomized, Single-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines in Healthy Adults Aged 18 to 39 Years.', 'orgStudyIdInfo': {'id': 'V104P1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: Adjuvanted Influenza Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Biological: Influenza Vaccine']}], 'interventions': [{'name': 'Adjuvanted Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose of Adjuvanted Influenza Vaccine', 'armGroupLabels': ['1']}, {'name': 'Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose of Influenza Vaccine', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36 6853', 'city': 'Ligornetto', 'country': 'Switzerland', 'facility': 'I.P.A.S.', 'geoPoint': {'lat': 45.86161, 'lon': 8.95166}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}