Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT01651104
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2012-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects
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'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From day 1 through day 22.', 'description': 'Serious adverse events (SAEs) were collected from day 1 through day 22.', 'eventGroups': [{'id': 'EG000', 'title': '≥65 Y', 'description': 'Subjects ≥65 years of age who received one aTIV vaccination', 'otherNumAtRisk': 63, 'otherNumAffected': 28, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '≥65 Y', 'description': 'Subjects ≥65 years of age who received one aTIV vaccination'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '71'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '77'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '90'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.\n\nSeroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area.\n\nThe European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is 30% (≥65 years).', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '≥65 Y', 'description': 'Subjects ≥65 years of age who received one aTIV vaccination'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '2.46', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '3.12'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '2.68', 'groupId': 'OG000', 'lowerLimit': '2.15', 'upperLimit': '3.35'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '4.44', 'groupId': 'OG000', 'lowerLimit': '3.53', 'upperLimit': '5.58'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after 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 on the PP set.'}, {'type': 'PRIMARY', 'title': 'Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '≥65 Y', 'description': 'Subjects ≥65 years of age who received one aTIV vaccination'}], 'classes': [{'title': 'A/H1N1 (Day 1)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '68'}]}]}, {'title': 'A/H1N1 (Day 22)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '100'}]}]}, {'title': 'A/H3N2 (Day 1)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '62'}]}]}, {'title': 'A/H3N2 (Day 22)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '98'}]}]}, {'title': 'B (Day 1)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '31'}]}]}, {'title': 'B (Day 22)', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and 22', 'description': 'Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after aTIV vaccination (day 22).\n\nThis criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years).', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the PP set.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '≥65 Y', 'description': 'Subjects ≥65 years of age who received one aTIV vaccination'}], 'classes': [{'title': 'Injection site ecchymosis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Injection site induration', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Chills/shivering', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Sweating (N=62)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue (N=62)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Fever (≥38°C)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 through day 4 postvaccination', 'description': 'Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the aTIV vaccination.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '≥65 Y', 'description': 'Subjects ≥65 years of age who received one aTIV vaccination'}], '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': 'Subjects were enrolled at one study center in Belgium.', 'preAssignmentDetails': 'All enrolled subjects were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '≥65 Y', 'description': 'Subjects ≥65 years of age who received one aTIV vaccination'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis was performed on all enrolled subjects.'}}, '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': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-03', 'studyFirstSubmitDate': '2012-07-24', 'resultsFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2012-07-24', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-19', 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV', 'timeFrame': 'Day 22', 'description': 'Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.\n\nSeroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area.\n\nThe European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is 30% (≥65 years).'}, {'measure': 'Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV', 'timeFrame': 'Day 22', 'description': 'Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after 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': 'Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV', 'timeFrame': 'Day 1 and 22', 'description': 'Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after aTIV vaccination (day 22).\n\nThis criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years).'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)', 'timeFrame': 'From day 1 through day 4 postvaccination', 'description': 'Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the aTIV vaccination.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza, Trivalent, Adjuvanted, Adjuvant, MF59, MF-59, Fluad, Seasonal'], 'conditions': ['Human Influenza']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety of a single intramuscular (IM) injection of trivalent adjuvanted influenza study vaccine, formulation 2012/2013, in elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;\n2. Individuals able to comply with all the study requirements;\n3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.\n\nExclusion Criteria:\n\n1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study.\n2. Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:\n\n * Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment);\n * Medically significant advanced congestive heart failure (ie. NYHA class III and IV);\n * Chronic obstructive pulmonary disease (COPD; i.e., GOLD Stage III and IV);\n * Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years);\n * Diabetes mellitus type I;\n * Poorly controlled diabetes mellitus type II;\n * Advanced arteriosclerotic disease;\n * History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome);\n * Acute or progressive hepatic disease;\n * Acute or progressive renal disease;\n * Severe neurological (es. Guillain-Barré syndrome) or psychiatric disorder;\n * Severe asthma.\n3. Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate).\n4. Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:\n\n * Receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;\n * Receipt of immunostimulants;\n * Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;\n * Suspected or known HIV infection or HIV-related disease.\n5. Individuals with known or suspected history of drug or alcohol abuse.\n6. 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.\n7. Individuals who were not able to comprehend and to follow all required study procedures for the whole period of the study.\n8. Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.\n9. Individuals who within the past 6 months have:\n\n * had any laboratory confirmed seasonal or pandemic influenza disease;\n * received any seasonal or pandemic influenza vaccine.\n10. Individuals who received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study.\n11. Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.\n12. Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.\n13. 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.\n14. Individuals who were part of study personnel or close family members conducting this study.\n15. BMI \\>35 kg/m2."}, 'identificationModule': {'nctId': 'NCT01651104', 'briefTitle': 'Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 2, Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine (Fluad®), Formulation 2012/2013, When Administered to Elderly Subjects', 'orgStudyIdInfo': {'id': 'V70_39S'}, 'secondaryIdInfos': [{'id': '2012-000085-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjuvanted Trivalent Influenza Virus Vaccine', 'interventionNames': ['Biological: Adjuvanted Trivalent Influenza Virus Vaccine (aTIV)']}], 'interventions': [{'name': 'Adjuvanted Trivalent Influenza Virus Vaccine (aTIV)', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL dose of study vaccine supplied in prefilled syringes was administered intramuscularly in the deltoid muscle, preferably of the non dominant arm.', 'armGroupLabels': ['Adjuvanted Trivalent Influenza Virus Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '185', 'city': 'De Pintelaan', 'state': 'Be-9000 Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent Center for Vaccinology'}], 'overallOfficials': [{'name': 'Novartis Vaccines and Diagnostics', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}