Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-03-12 @ 5:27 AM
Study NCT ID:
NCT02381418
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2015-03-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season
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': 'serge.vandewitte@abbott.com', 'phone': '+31294477184', 'title': 'Global Clinical Director', 'organization': 'Abbott'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Influvac', 'description': 'Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "', 'otherNumAtRisk': 120, 'otherNumAffected': 19, 'seriousNumAtRisk': 120, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'vaccine site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'vaccination site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Influvac', 'description': 'Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "'}], 'classes': [{'title': 'Percentage adults with seroprotection for A/H3N2', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '99.6'}]}]}, {'title': 'Percentage adults with seroprotection for A/H1N1', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '99.6'}]}]}, {'title': 'Percentage adults with seroprotection for B', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '98.1'}]}]}, {'title': 'Percentage elderly with seroprotection for A/H3N2', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '90.9', 'upperLimit': '100'}]}]}, {'title': 'Percentage elderly with seroprotection for A/H1N1', 'categories': [{'measurements': [{'value': '88.1', 'groupId': 'OG000', 'lowerLimit': '77.1', 'upperLimit': '95.1'}]}]}, {'title': 'Percentage elderly with seroprotection for B', 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000', 'lowerLimit': '50.9', 'upperLimit': '76.4'}]}]}, {'title': 'Percentage adults with seroconversion for A/H3N2', 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000', 'lowerLimit': '71.0', 'upperLimit': '91.6'}]}]}, {'title': 'Percentage adults with seroconversion for A/H1N1', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000', 'lowerLimit': '37.5', 'upperLimit': '64.1'}]}]}, {'title': 'Percentage adults with seroconversion for B', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000', 'lowerLimit': '39.1', 'upperLimit': '65.7'}]}]}, {'title': 'Percentage elderly with seroconversion for A/H3N2', 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '63.4', 'upperLimit': '86.4'}]}]}, {'title': 'Percentage elderly with seroconversion for A/H1N1', 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '45.6'}]}]}, {'title': 'Percentage elderly with seroconversion for B', 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '49.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks post vaccination', 'description': 'Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.'}, {'type': 'PRIMARY', 'title': 'the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Influvac', 'description': 'Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "\n\nTrivalent influenza subunit vaccine Influvac: "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "'}], 'classes': [{'title': 'Mean fold increase A/H3N2 titer in adults', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '29.7'}]}]}, {'title': 'Mean fold increase A/H1N1 titer in adults', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '15.0'}]}]}, {'title': 'Mean fold increase B titer in adults', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '8.3'}]}]}, {'title': 'Mean fold increase A/H3N2 titer in elderly', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '17.8'}]}]}, {'title': 'Mean fold increase A/H1N1 titer in elderly', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '4.2'}]}]}, {'title': 'Mean fold increase B titer in elderly', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks post vaccination', 'description': 'Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.'}, {'type': 'SECONDARY', 'title': 'Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Influvac', 'description': 'Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "'}], 'classes': [{'title': 'Redness (18-60 years of age)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Swelling (18-60 years of age)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Itching (18-60 years of age)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Warmth (18-60 years of age)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Tenderness (18-60 years of age)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Pain (18-60 years of age)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Impairment of movement of arm (18-60 years of age)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Induration (hardening) (18-60 year of age)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Ecchymosis (blue spots) (18-60 year of age)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fever >=38c (18-60 year of age)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Increased sweating (18-60 year of age)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Headache (18-60 year of age)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Malaise (18-60 year of age)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue (18-60 year of age)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Shivering (18-60 year of age)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Redness (>=61 year of age)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Swelling (>=61 year of age)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Itching (>=61 year of age)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Warmth (>=61 year of age)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Tenderness (>=61 year of age)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Pain (>=61 year of age)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Impairment of movement arm (>=61 year of age)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Induration (hardening) (>=61 year of age)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Ecchymosis (blue spots) (>=61 year of age)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fever >-38c (>=61 year of age)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Increased sweating (>=61 year of age)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Headache (>=61 year of age)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Malaise(>=61 year of age)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue (>=61 year of age)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Shivering', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 3 weeks post vaccination', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Influvac', 'description': 'Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Influvac', 'description': 'Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': 'adult (18-60 year old)', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '60'}]}]}, {'title': 'elderly adult (>=61 year old)', 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'BG000', 'lowerLimit': '61', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2015-03-03', 'resultsFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-31', 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.', 'timeFrame': '3 weeks post vaccination', 'description': 'Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.'}, {'measure': 'the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.', 'timeFrame': '3 weeks post vaccination', 'description': 'Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.'}], 'secondaryOutcomes': [{'measure': 'Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.', 'timeFrame': 'up to 3 weeks post vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Vaccine', 'Committee for Medicinal Products for Human Use (CHMP) criteria'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: subjects aged \\>= 18 and \\<= 60 years and subjects \\>= 61 years of age (elderly).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to give informed consent and able to adhere to all protocol required study procedures.\n* Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.\n* Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator\n\nExclusion Criteria:\n\n* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.\n* A serious adverse reaction after a previous (influenza) vaccination.\n* Presence of any significant condition that may prohibit inclusion as determined by the investigator.\n* Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.\n* A history of Guillain-Barré syndrome or active neurological disease.'}, 'identificationModule': {'nctId': 'NCT02381418', 'briefTitle': 'Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Southern Hemisphere Season 2015. An Open-Label, Baseline-Controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age', 'orgStudyIdInfo': {'id': 'INFL3014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "', 'interventionNames': ['Biological: Trivalent influenza subunit vaccine Influvac']}], 'interventions': [{'name': 'Trivalent influenza subunit vaccine Influvac', 'type': 'BIOLOGICAL', 'description': '"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NSW 2035', 'city': 'Maroubra', 'country': 'Australia', 'facility': 'Research Facility ID ORG-001075', 'geoPoint': {'lat': -33.95, 'lon': 151.23333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}