Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-05 @ 5:26 PM
Study NCT ID:
NCT01344057
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2011-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, '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 1 through Day 22.', '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 trivalent subunit inactivated adjuvanted influenza vaccine FLUAD during the vaccination visit, according to the study protocol (follow-up period: until day 22).', 'otherNumAtRisk': 63, 'otherNumAffected': 6, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], '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': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD', 'description': 'Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.'}], 'classes': [{'title': 'A/H1N1 (N= 62)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '80'}]}]}, {'title': 'A/H3N2 (N= 62)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '63'}]}]}, {'title': 'B (N= 62)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '38'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 22', '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 22), 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 correctly received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violations.'}, {'type': 'SECONDARY', '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 dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.'}], 'classes': [{'title': 'Injection site ecchymosis (N= 62)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Injection site erythema (N= 62)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Injection site induration (N= 62)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Injection site swelling (N= 62)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Injection site pain (N= 62)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Chills Shivering (N= 62)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Malaise (N= 62)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Myalgia (N= 62)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Arthralgia (N= 62)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Headache (N= 62)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Sweating (N= 62)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue (N= 62)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Fever (≥38°C) (N= 61)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 to 4 days post-vaccination', 'description': 'Safety was assessed for participants who reported solicited local and systemic reactions from day 1 up to and including day 4 after the FLUAD vaccination.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done using the safety dataset; participants who received study vaccination and who provided post-vaccination safety data.'}, {'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': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD', 'description': 'Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.'}], 'classes': [{'title': 'A/H1N1 (N= 62)', 'categories': [{'measurements': [{'value': '2.54', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '3.07'}]}]}, {'title': 'A/H3N2 (N= 62)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.63', 'upperLimit': '2.2'}]}]}, {'title': 'B (N= 62)', 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '1.21', 'upperLimit': '1.53'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'day 22', '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 22).\n\nThe CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) 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': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD', 'description': 'Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.'}], 'classes': [{'title': 'A/H1N1 (N= 62)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '95'}]}]}, {'title': 'A/H3N2 (N= 62)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '80'}]}]}, {'title': 'B (N= 62)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '98'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 22', 'description': 'Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).\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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FLUAD', 'description': 'Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Premature Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Overall, 63 participants were ≥65 years of age were enrolled at 4 sites in Italy.', 'preAssignmentDetails': 'Blood sample for immunogenicity assays were collected before vaccination (Day 1) and after 21 Days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FLUAD', 'description': 'Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.2', 'spread': '5.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population was defined as all participants who were enrolled into the study.'}}, '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': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2011-04-21', 'resultsFirstSubmitDate': '2015-12-21', 'studyFirstSubmitQcDate': '2011-04-27', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-21', 'studyFirstPostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', '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 22', '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 22), 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 22', '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 22).\n\nThe CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) 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 22', 'description': 'Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).\n\nThis criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Reported Solicited Local and Systemic Reactions', 'timeFrame': '1 to 4 days post-vaccination', 'description': 'Safety was assessed for participants who reported solicited local and systemic reactions from day 1 up to and including day 4 after the FLUAD vaccination.'}]}, 'conditionsModule': {'keywords': ['Seasonal Influenza, vaccine'], 'conditions': ['Seasonal Influenza']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza Vaccine Administered to Elderly Subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Males and females volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry.\n* Individuals able to comply with all the study requirements.\n* Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.\n* Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.\n\nKey Exclusion Criteria:\n\n* Individuals with any serious chronic or acute disease.\n* Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination.\n* Individuals with known or suspected impairment/alteration of immune function.\n* Individuals with known or suspected history of drug or alcohol abuse.\n* Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject.\n* Individuals within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine.\n* Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.\n* Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.\n* Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.\n* Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines.\n* Individuals who are part of study personnel or close family members conducting this study.\n* BMI \\> 35 kg/m2."}, 'identificationModule': {'nctId': 'NCT01344057', 'briefTitle': 'Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2011-2012, When Administered to Elderly Subjects', 'orgStudyIdInfo': {'id': 'V70_32S'}, 'secondaryIdInfos': [{'id': '2010-021841-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine', 'description': 'No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit', 'interventionNames': ['Biological: Seasonal Influenza Vaccine']}], 'interventions': [{'name': 'Seasonal Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'This phase II is performed as a multicenter study in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .', 'armGroupLabels': ['Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Via Dei Vestini', 'state': 'Chieti', 'country': 'Italy', 'facility': "Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio"}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Department of "Scienze della Salute" University of Genova Via Pastore 1', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '66034', 'city': 'Lanciano', 'country': 'Italy', 'facility': 'Satellite: "ASL Lanciano - Vasto", sede legale Via S Spaventa 37', 'geoPoint': {'lat': 42.22718, 'lon': 14.39024}}, {'city': 'Lanciano', 'country': 'Italy', 'facility': 'Satellite: "Distretto Sanitario di Base di Fossacesia" in Via Polidoro-Vasto', 'geoPoint': {'lat': 42.22718, 'lon': 14.39024}}, {'zip': '20127', 'city': 'Milan', 'country': 'Italy', 'facility': "Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona 20", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20052', 'city': 'Monza', 'country': 'Italy', 'facility': 'Department of "malattie infettive" Ospedale San Gerardo, via Pergolesi 33', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}