Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT01198769
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2010-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, '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': 'SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period', 'eventGroups': [{'id': 'EG000', 'title': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months post-Dose 2 (at study Month 4)', 'description': 'Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (\\<) 20 U/mL.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.'}, {'type': 'SECONDARY', 'title': 'Serum Anti-rotavirus IgA Antibody Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '254.7', 'groupId': 'OG000', 'lowerLimit': '145.0', 'upperLimit': '447.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 months post-Dose 2 (at study Month 4)', 'description': 'Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.', 'unitOfMeasure': 'U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited General Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.'}], 'classes': [{'title': 'Cough', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Loss of appetite', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Temperature (Tympanic on rectal seting (>=38.0°C))', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 8-day (Days 0-7) post-vaccination period', 'description': 'Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total vaccinated cohort included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)', 'description': 'RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample.\n\nGE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total vaccinated cohort included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the 31-day (Days 0-30) follow-up period after vaccination', 'description': 'An unsolicited adverse event is any adverse event (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.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total vaccinated cohort included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (from Dose 1 at Day 0 up to Month 4)', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total vaccinated cohort included all subjects with at least one vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '0.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', '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': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2011-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2010-09-09', 'resultsFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-03-22', 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.', 'timeFrame': '2 months post-Dose 2 (at study Month 4)', 'description': 'Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (\\<) 20 U/mL.'}], 'secondaryOutcomes': [{'measure': 'Serum Anti-rotavirus IgA Antibody Concentrations.', 'timeFrame': '2 months post-Dose 2 (at study Month 4)', 'description': 'Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.'}, {'measure': 'Number of Subjects Reporting Solicited General Symptoms.', 'timeFrame': 'During the 8-day (Days 0-7) post-vaccination period', 'description': 'Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.'}, {'measure': 'Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.', 'timeFrame': 'From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)', 'description': 'RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample.\n\nGE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs).', 'timeFrame': 'Within the 31-day (Days 0-30) follow-up period after vaccination', 'description': 'An unsolicited adverse event is any adverse event (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.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs).', 'timeFrame': 'During the entire study period (from Dose 1 at Day 0 up to Month 4)', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.'}]}, 'conditionsModule': {'keywords': ['Human rotavirus vaccine'], 'conditions': ['Infections, Rotavirus']}, 'referencesModule': {'availIpds': [{'id': '114351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114351', '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': '114351', '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': '114351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114351', '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': '114351', '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': '24079716', 'type': 'DERIVED', 'citation': 'Lu CY, Chang LY, Shao PL, Suryakiran PV, Han HH, Huang LM. Immunogenicity, reactogenicity, and safety of a human rotavirus vaccine, Rotarix, in Taiwanese infants who received a dose of hepatitis B immunoglobulin after birth. J Formos Med Assoc. 2013 Sep;112(9):574-7. doi: 10.1016/j.jfma.2012.11.016. Epub 2013 Jan 3.'}], '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': 'The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.\n* A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.\n* Written informed consent obtained from the parent(s)/Legally Acceptable Representative(s) of the subject.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Infants who have received a previous dose of hepatitis B immunoglobulin after birth.\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 first dose of study vaccine, or planned use during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs with the exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in the study area for the duration of the study.\n* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.\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* Previous vaccination against rotavirus.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Family history of congenital or hereditary immunodeficiency.\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 (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period.\n* Gastroenteritis within 7 days preceding the study vaccine administration.\n* Previous confirmed occurrence of Rotavirus gastroenteritis.'}, 'identificationModule': {'nctId': 'NCT01198769', 'briefTitle': 'Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity, Reactogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.", 'orgStudyIdInfo': {'id': '114351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotarix Group', 'description': 'subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.', 'interventionNames': ['Biological: Rotarix TM']}], 'interventions': [{'name': 'Rotarix TM', 'type': 'BIOLOGICAL', 'description': 'Oral, 2 doses', 'armGroupLabels': ['Rotarix Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}