Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-31 @ 2:03 PM
Study NCT ID:
NCT00956761
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2009-08-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics S.r.l'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 0 through Day 21.', 'description': 'Adverse events other than local and systemic reactions or solicited reactions lasting longer than 3 days after vaccination were documented during the study period.', 'eventGroups': [{'id': 'EG000', 'title': 'FLUAD', 'description': 'Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.', 'otherNumAtRisk': 63, 'otherNumAffected': 2, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD', 'description': 'Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '56'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '59'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '56'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 21', 'description': 'Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.\n\nSeroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.\n\nThe European (Committee for Medicinal Products for Human Use \\[CHMP\\]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD', 'description': 'Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000', 'lowerLimit': '1.33', 'upperLimit': '1.81'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '1.53', 'groupId': 'OG000', 'lowerLimit': '1.31', 'upperLimit': '1.79'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000', 'lowerLimit': '1.36', 'upperLimit': '1.87'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'day 21', 'description': 'Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).\n\nThe CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is \\>2.0 (≥65 years).', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done using PP set.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD', 'description': 'Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '98'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '98'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 21', 'description': 'Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).\n\nThis criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done using PP set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Solicited Local and Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD', 'description': 'Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.'}], 'classes': [{'title': 'Injection site ecchymosis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Injection site induration', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Chills Shivering', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Sweating', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fever (≥38°C)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 days post-vaccination', 'description': 'Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FLUAD', 'description': 'Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Overall, 63 participants ≥65 years of age were enrolled at 2 sites in Italy.', 'preAssignmentDetails': 'Blood samples for the determination of antibody titers were drawn on Day 0 prior to vaccination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FLUAD', 'description': 'Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.9', 'spread': '6.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population was defined as all participants who were enrolled.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2009-08-08', 'resultsFirstSubmitDate': '2015-12-21', 'studyFirstSubmitQcDate': '2009-08-10', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-21', 'studyFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD', 'timeFrame': 'Day 21', 'description': 'Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.\n\nSeroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.\n\nThe European (Committee for Medicinal Products for Human Use \\[CHMP\\]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years).'}, {'measure': 'Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD', 'timeFrame': 'day 21', 'description': 'Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).\n\nThe CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is \\>2.0 (≥65 years).'}, {'measure': 'Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD', 'timeFrame': 'day 21', 'description': 'Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).\n\nThis criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years).'}, {'measure': 'Number of Participants Who Reported Solicited Local and Systemic Reactions', 'timeFrame': '0-3 days post-vaccination', 'description': 'Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.'}]}, 'conditionsModule': {'keywords': ['Influenza vaccine'], 'conditions': ['Seasonal Influenza']}, 'descriptionModule': {'briefSummary': 'This is a trial for annual registration of the updated seasonal influenza vaccine formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Subjects of 65 years of age or older\n* Mentally competent\n* Willing and able to give written informed consent prior to study entry\n* Able to comply with all the study requirements\n* In general good health\n\nKey Exclusion Criteria:\n\n* Any serious chronic or acute disease disease\n* History of any anaphylactic reaction and/or serious allergic reaction following a vaccination\n* A proven hypersensitivity to any component of the study vaccine\n* Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)\n* Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject\n* Within the past 12 months, participants had received more than one injection of influenza vaccine\n* Within the past 6 months, participants had laboratory confirmed influenza disease or received influenza vaccine"}, 'identificationModule': {'nctId': 'NCT00956761', 'briefTitle': 'Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD® Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2009-2010, When Administered to Elderly Subjects', 'orgStudyIdInfo': {'id': 'V70_09S'}, 'secondaryIdInfos': [{'id': '2009-010586-23'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: Seasonal Influenza Vaccine (MF59C.1)']}], 'interventions': [{'name': 'Seasonal Influenza Vaccine (MF59C.1)', 'type': 'BIOLOGICAL', 'description': '1 dose of a surface antigen, inactivated, adjuvanted with MF59C.1, seasonal influenza vaccine, formulation 2009-2010', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66034', 'city': 'Lanciano', 'country': 'Italy', 'facility': 'Site 2: Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37', 'geoPoint': {'lat': 42.22718, 'lon': 14.39024}}, {'zip': '30034', 'city': 'Pianiga', 'country': 'Italy', 'facility': 'Site 3: Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano-Via Nazionale 48', 'geoPoint': {'lat': 45.45708, 'lon': 12.00762}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}