Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-01 @ 1:57 AM
Study NCT ID:
NCT01577732
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2012-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D004165', 'term': 'Diphtheria'}], 'ancestors': [{'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests 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': 'Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).', 'eventGroups': [{'id': 'EG000', 'title': 'Infanrix-IPV+Hib Group', 'description': 'Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 211, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 95}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 82}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability/fussiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 108}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 115}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 101}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 48}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix-IPV+Hib Group', 'description': 'Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 4-day (Days 0-3) follow up period after vaccination.', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix-IPV+Hib Group', 'description': 'Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability/fussiness', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 4-day (Days 0-3) follow up period after vaccination.', 'description': 'Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (\\>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix-IPV+Hib Group', 'description': 'Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 31-day (Days 0-30) follow up period after vaccination.', 'description': 'An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Any Serious Adverse Events (SAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix-IPV+Hib Group', 'description': 'Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (Days 0-30).', 'description': 'SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infanrix-IPV+Hib Group', 'description': 'Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '321 subjects were screened and allocated a subject number for the study, out of which 300 participated in the study and received the study vaccination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Infanrix-IPV+Hib Group', 'description': 'Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'spread': '2.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '157', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 321}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2013-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-03', 'studyFirstSubmitDate': '2012-04-05', 'resultsFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2012-04-12', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-03', 'studyFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting Solicited Local Symptoms', 'timeFrame': 'Within the 4-day (Days 0-3) follow up period after vaccination.', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.'}, {'measure': 'Number of Subjects Reporting Solicited General Symptoms', 'timeFrame': 'Within the 4-day (Days 0-3) follow up period after vaccination.', 'description': 'Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (\\>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.'}, {'measure': 'Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).', 'timeFrame': 'Within the 31-day (Days 0-30) follow up period after vaccination.', 'description': 'An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.'}, {'measure': 'Number of Subjects Reporting Any Serious Adverse Events (SAEs).', 'timeFrame': 'During the entire study period (Days 0-30).', 'description': 'SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.'}]}, 'conditionsModule': {'keywords': ['booster', 'Infanrix-IPV+HibTM', 'DTPa-IPV/Hib', 'Vietnamese toddlers'], 'conditions': ['Acellular Pertussis', 'Haemophilus Influenzae Type b', 'Tetanus', 'Poliomyelitis', 'Diphtheria', 'Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines']}, 'referencesModule': {'availIpds': [{'id': '115389', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115389', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115389', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115389', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115389', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115389', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '26337197', 'type': 'BACKGROUND', 'citation': 'Anh DD, Van Der Meeren O, Karkada N, Assudani D, Yu TW, Han HH. Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine in healthy Vietnamese toddlers: An open-label, phase III study. Hum Vaccin Immunother. 2016 Mar 3;12(3):655-7. doi: 10.1080/21645515.2015.1084451.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \\[LAR(s)\\] can and will comply with the requirements of the protocol.\n* A male or female between, and including, 12 and 24 months of age at the time of vaccination.\n* Written informed consent obtained from the parent(s)/LAR(s) of the subject.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Subjects who were primed with three doses of a DTP and polio vaccine in the first 6 months of life, and who have received the last dose of the primary vaccination at least six months before the receipt of study vaccine.\n\nExclusion Criteria:\n\n* Child in care.\n* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.\n* Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.\n* Evidence of previous or intercurrent booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease or vaccination.\n* History of any neurological disorders or seizures.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.\n* Major congenital defects or serious chronic illness.\n* Acute disease and/or fever at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.'}, 'identificationModule': {'nctId': 'NCT01577732', 'briefTitle': "Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+HibTM) in Healthy Vietnamese Toddlers", 'orgStudyIdInfo': {'id': '115389'}, 'secondaryIdInfos': [{'id': '2013-002538-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infanrix-IPV+Hib Group', 'description': 'Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.', 'interventionNames': ['Biological: Infanrix-IPV+Hib™']}], 'interventions': [{'name': 'Infanrix-IPV+Hib™', 'type': 'BIOLOGICAL', 'description': 'Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.', 'armGroupLabels': ['Infanrix-IPV+Hib Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haiphong', 'country': 'Vietnam', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 20.86481, 'lon': 106.68345}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=4633', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}