Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT01306305
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2011-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C475022', 'term': 'Inflexal V'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@crucell.com', 'phone': '+41(0)319806111', 'title': 'Medical Affairs Director', 'organization': 'Crucell Switzerland AG'}, 'certainAgreement': {'otherDetails': 'The investigator to submit all manuscripts/abstracts to the sponsor for review at least 6 weeks before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Adults', 'description': 'Adults from 18 to 60 years old inclusive', 'otherNumAtRisk': 55, 'otherNumAffected': 30, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Elderly', 'description': 'Elderly subjects aged over 60 years', 'otherNumAtRisk': 55, 'otherNumAffected': 26, 'seriousNumAtRisk': 55, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site haemorrhage (ecchymosis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia (Fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Heat stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Seroconversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults', 'description': 'Adults from 18 to 60 years old inclusive'}, {'id': 'OG001', 'title': 'Elderly', 'description': 'Elderly subjects aged over 60 years'}], 'classes': [{'title': 'A/California/7/2009', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'A/Perth/16/2009', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22 ± 2 days', 'description': 'Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject lost to follow up and one subject who withdrew consent'}, {'type': 'SECONDARY', 'title': 'Safety: Numbers of Subjects Reporting Solicited Local Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults', 'description': 'Adults from 18 to 60 years old inclusive'}, {'id': 'OG001', 'title': 'Elderly', 'description': 'Elderly subjects aged over 60 years'}], 'classes': [{'title': 'Ecchymosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 to 4 inclusive, and Days 8, 15 and 22', 'description': 'Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all subjects who received study vaccine'}, {'type': 'PRIMARY', 'title': 'Seroprotection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults', 'description': 'Adults from 18 to 60 years old inclusive'}, {'id': 'OG001', 'title': 'Elderly', 'description': 'Elderly subjects aged over 60 years'}], 'classes': [{'title': 'A/California/7/2009', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'A/Perth/16/2009', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22 ± 2 days', 'description': 'Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT/ATP'}, {'type': 'PRIMARY', 'title': 'Fold Increase in Geometric Mean Titer (GMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults', 'description': 'Adults from 18 to 60 years old inclusive'}, {'id': 'OG001', 'title': 'Elderly', 'description': 'Elderly subjects aged over 60 years'}], 'classes': [{'title': 'A/California/7/2009', 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}]}]}, {'title': 'A/Perth/16/2009', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '14.0', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22/Day 1', 'description': 'GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value', 'unitOfMeasure': 'Fold (ratio)', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT/ATP'}, {'type': 'SECONDARY', 'title': 'Numbers of Subjects Reporting Solicited Systemic Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults', 'description': 'Adults from 18 to 60 years old inclusive'}, {'id': 'OG001', 'title': 'Elderly', 'description': 'Elderly subjects aged over 60 years'}], 'classes': [{'title': 'Shivering', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 to 4 inclusive, and Days 8, 15 and 22', 'description': 'Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adults', 'description': 'Adults from 18 to 60 years old inclusive'}, {'id': 'FG001', 'title': 'Elderly', 'description': 'Elderly subjects aged over 60 years'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at one center in Switzerland First subject first visit (FSFV): 28-Jun-2010 Last subject last visit (LSLV): 20-Jul-2010'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adults', 'description': 'Adults from 18 to 60 years old inclusive'}, {'id': 'BG001', 'title': 'Elderly', 'description': 'Elderly subjects aged over 60 years'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '69.8', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '56.4', 'spread': '16.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-29', 'studyFirstSubmitDate': '2011-02-28', 'resultsFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2011-02-28', 'lastUpdatePostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-01', 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion', 'timeFrame': 'Day 22 ± 2 days', 'description': 'Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40'}, {'measure': 'Seroprotection', 'timeFrame': 'Day 22 ± 2 days', 'description': 'Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40'}, {'measure': 'Fold Increase in Geometric Mean Titer (GMT)', 'timeFrame': 'Day 22/Day 1', 'description': 'GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value'}], 'secondaryOutcomes': [{'measure': 'Safety: Numbers of Subjects Reporting Solicited Local Adverse Events', 'timeFrame': 'Days 1 to 4 inclusive, and Days 8, 15 and 22', 'description': 'Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.'}, {'measure': 'Numbers of Subjects Reporting Solicited Systemic Adverse Events', 'timeFrame': 'Days 1 to 4 inclusive, and Days 8, 15 and 22', 'description': 'Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Virus', 'Vaccination', 'Immunisation'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female and male adults\n* Aged ≥18 to ≤60 years or \\>60 years on Day 1\n* Written informed consent\n\nExclusion Criteria:\n\n* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease\n* Acute febrile illness (≥38.0 °C)\n* Prior vaccination with an influenza vaccine in the past 330 days\n* Known hypersensitivity to any vaccine component\n* Previous history of a serious adverse reaction to influenza vaccine\n* History of egg protein allergy or severe atopy\n* Known blood coagulation disorder\n* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)\n* Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)\n* Investigational medicinal product received in the past 3 months (90 days)\n* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)\n* Pregnancy or lactation\n* Participation in another clinical trial\n* Employee at the investigational site, or relative or spouse of the investigator\n* Suspected non-compliance'}, 'identificationModule': {'nctId': 'NCT01306305', 'briefTitle': 'A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crucell Holland BV'}, 'officialTitle': 'Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2010/2011-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations', 'orgStudyIdInfo': {'id': 'INF-V-A004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elderly', 'description': 'Elderly subjects aged over 60 years', 'interventionNames': ['Biological: Inflexal V']}, {'type': 'EXPERIMENTAL', 'label': 'Adults', 'description': 'Adults from 18 to 60 years old inclusive', 'interventionNames': ['Biological: Inflexal V']}], 'interventions': [{'name': 'Inflexal V', 'type': 'BIOLOGICAL', 'description': 'Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 season, containing per 0.5 mL dose:\n\n* 15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus\n* 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus\n* 15 µg HA antigen of B/Brisbane/60/2008-like virus\n\nDose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1', 'armGroupLabels': ['Adults', 'Elderly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4123', 'city': 'Allschwil', 'country': 'Switzerland', 'facility': 'Covance Clinical Research Unit AG', 'geoPoint': {'lat': 47.55074, 'lon': 7.53599}}], 'overallOfficials': [{'name': 'Michael Seiberling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance Clinical Research Unit AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crucell Holland BV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}