Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-01 @ 5:53 PM
Study NCT ID:
NCT01863433
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Seqirus.ClinicalTrials@Seqirus.com', 'phone': '1-855-358-8966', 'title': 'Clinical Trial Disclosure Manager', 'organization': 'Seqirus'}, 'certainAgreement': {'otherDetails': 'CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days).', 'description': 'The other AEs presented include solicited and unsolicited AEs. The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.', 'eventGroups': [{'id': 'EG000', 'title': 'Trivalent Influenza Vaccine', 'description': 'Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.', 'otherNumAtRisk': 120, 'otherNumAffected': 81, 'seriousNumAtRisk': 120, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 64, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Headache', 'notes': 'Unsolicited adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 41, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trivalent Influenza Vaccine', 'description': 'Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.'}], 'classes': [{'title': 'H1N1 strain', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '70.6', 'upperLimit': '85.9'}]}]}, {'title': 'H3N2 strain', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '70.6', 'upperLimit': '85.9'}]}]}, {'title': 'B strain', 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '55.4', 'upperLimit': '73.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 21 days after vaccination', 'description': 'As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \\< 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.'}, {'type': 'PRIMARY', 'title': 'The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trivalent Influenza Vaccine', 'description': 'Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.'}], 'classes': [{'title': 'H1N1 strain', 'categories': [{'measurements': [{'value': '15.01', 'spread': '4.27', 'groupId': 'OG000'}]}]}, {'title': 'H3N2 strain', 'categories': [{'measurements': [{'value': '13.18', 'spread': '4.494', 'groupId': 'OG000'}]}]}, {'title': 'B strain', 'categories': [{'measurements': [{'value': '5.86', 'spread': '3.461', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Approximately 21 days after vaccination', 'description': 'GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.', 'unitOfMeasure': 'fold increase', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.'}, {'type': 'PRIMARY', 'title': 'The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trivalent Influenza Vaccine', 'description': 'Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.'}], 'classes': [{'title': 'H1N1 strain', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '99.5'}]}]}, {'title': 'H3N2 strain', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}]}]}, {'title': 'B strain', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '98.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 21 days after vaccination', 'description': 'For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.'}, {'type': 'SECONDARY', 'title': 'Type and Frequency of Any Solicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trivalent Influenza Vaccine', 'description': 'Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.'}], 'classes': [{'title': 'Any solicited local AE', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000'}]}]}, {'title': 'Induration > 50 mm', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Ecchymosis', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}]}]}, {'title': 'Any solicited systemic AE', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}]}]}, {'title': 'Temperature > 38°C for ≥ 24 hours', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4 days after vaccination (Day 0 plus 3 days)', 'description': 'The percentage of participants reporting any solicited AEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.'}, {'type': 'SECONDARY', 'title': 'Type and Frequency of Any Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trivalent Influenza Vaccine', 'description': 'Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After vaccination until the end of the study; approximately 21 days.', 'description': 'The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trivalent Influenza Vaccine', 'description': 'Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '1 subject was withdrawn from the study due to evidence of substance abuse.', 'groupId': 'FG000', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was open label, non-randomized with single group assignment in healthy volunteers aged 18 to 60 years.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Trivalent Influenza Vaccine', 'description': 'Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '10.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2013-05-23', 'resultsFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-11-26', 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.', 'timeFrame': 'Approximately 21 days after vaccination', 'description': 'As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \\< 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.'}, {'measure': 'The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.', 'timeFrame': 'Approximately 21 days after vaccination', 'description': 'GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.'}, {'measure': 'The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.', 'timeFrame': 'Approximately 21 days after vaccination', 'description': 'For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.'}], 'secondaryOutcomes': [{'measure': 'Type and Frequency of Any Solicited Adverse Events (AEs)', 'timeFrame': 'During the 4 days after vaccination (Day 0 plus 3 days)', 'description': 'The percentage of participants reporting any solicited AEs.'}, {'measure': 'Type and Frequency of Any Unsolicited AEs', 'timeFrame': 'After vaccination until the end of the study; approximately 21 days.', 'description': 'The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Influenza, Human']}, 'descriptionModule': {'briefSummary': 'This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged between 18 and 60 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females aged between 18 and 60 years at the time of vaccination.\n* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.\n\nExclusion Criteria:\n\n* Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.\n* Clinical signs of an active infection.\n* A clinically significant medical condition.\n* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.\n* Females who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT01863433', 'briefTitle': 'A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seqirus'}, 'officialTitle': 'A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2013/2014 Formulation of a bioCSL Split Virion, Inactivated Influenza Vaccine in Healthy Volunteers Aged 18-60 Years', 'orgStudyIdInfo': {'id': 'CSLCT-TIV-13-84'}, 'secondaryIdInfos': [{'id': '2013-001420-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trivalent Influenza Vaccine', 'description': 'The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection.', 'interventionNames': ['Biological: Trivalent Influenza Vaccine']}], 'interventions': [{'name': 'Trivalent Influenza Vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Trivalent Influenza Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Study Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'bioCSL Head of Clinical Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seqirus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seqirus', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}