Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT00750893
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2008-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C492457', 'term': 'RIX4414 vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', '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': 'Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively.', 'description': "Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.", 'eventGroups': [{'id': 'EG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.', 'otherNumAtRisk': 3111, 'deathsNumAtRisk': 3111, 'otherNumAffected': 684, 'seriousNumAtRisk': 3111, 'deathsNumAffected': 0, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 204}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 259}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 405}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 200}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 268}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Ileus paralytic', 'notes': '"Gastro-intestinal system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colitis', 'notes': '"Gastro-intestinal system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis Media', 'notes': '"Resistance mechanism disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'notes': '"Resistance mechanism disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'notes': '"Gastro-intestinal system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'notes': '"Respiratory system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydronephrosis', 'notes': '"Urinary System Disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchopneumonia', 'notes': '"Respiratory system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'notes': '"Respiratory system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchiolitis', 'notes': '"Respiratory system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Croup', 'notes': '"Respiratory system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'notes': '"Respiratory system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis viral', 'notes': '"Gastro-intestinal system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia viral', 'notes': '"Respiratory system disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'notes': '"Urinary System Disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fever', 'notes': '"Body as a whole - general disorders" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cytomegalovirus Gastrointestinal Infection', 'notes': '"Secondary items - events" SOC as per WHO-ART dictionary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA; WHO-ART'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '876', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'classes': [{'title': 'Cough', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '405', 'groupId': 'OG000'}]}]}, {'title': 'Loss of appetite', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}]}]}, {'title': 'Temperature', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period', 'description': 'Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 1 and Year 2.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '876', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '334', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period', 'description': 'Unsolicited AE covers any AE 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 1 and Year 2.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1052', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '413', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period', 'description': 'Unsolicited AE covers any AE 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 3 and Year 4.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '708', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31 day follow-up period after each vaccine dose for Year 5 study period', 'description': 'Unsolicited AE covers any AE 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 5.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '1201', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period', 'description': 'Unsolicited AE covers any AE 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available for the Year 1 to Year 6 study period.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '876', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the post-marketing study period for Year 1 & Year 2 study period', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented for whom data were available at Year 1 and Year 2.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1052', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the post-marketing study period for Year 3 & Year 4 study period', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented for whom data were available at Year 3 and Year 4.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '708', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the post-marketing study period for Year 5 study period', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented for whom data were available at Year 5.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the post-marketing study period for Year 1 to Year 6 study period', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available for Year 1 to Year 6 study period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2569'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '542'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '510'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}], 'recruitmentDetails': 'This post marketing study (PMS) covered a period of 6 consecutive years. Results were presented for Years 1, 2, 3, 4, 5 (Year \\[Y\\] 1 \\& Y2 data combined and presented at the Y2 time point and Y3 \\& Y4 data combined and presented at the Y4 time point) along with consolidated surveillance data from Y1- Y6 timepoint.', 'preAssignmentDetails': 'Consolidated participant flow and baseline measure data were given for Years 1 to 6 time point in order to account for all the subjects participating in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3111', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '2.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1525', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1586', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Korean', 'categories': [{'measurements': [{'value': '3107', 'groupId': 'BG000'}]}]}, {'title': 'Chinese', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Japanese', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2013-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2008-09-10', 'resultsFirstSubmitDate': '2011-01-28', 'studyFirstSubmitQcDate': '2008-09-10', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-01-28', 'studyFirstPostDateStruct': {'date': '2008-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting Solicited General Symptoms', 'timeFrame': 'During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period', 'description': 'Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period', 'timeFrame': 'During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period', 'description': 'Unsolicited AE covers any AE 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 Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period', 'timeFrame': 'During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period', 'description': 'Unsolicited AE covers any AE 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 Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period', 'timeFrame': 'During the 31 day follow-up period after each vaccine dose for Year 5 study period', 'description': 'Unsolicited AE covers any AE 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 Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period', 'timeFrame': 'During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period', 'description': 'Unsolicited AE covers any AE 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) During the Post-marketing Study Period for Year 1 & Year 2 Study Period', 'timeFrame': 'During the post-marketing study period for Year 1 & Year 2 study period', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period', 'timeFrame': 'During the post-marketing study period for Year 3 & Year 4 study period', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period', 'timeFrame': 'During the post-marketing study period for Year 5 study period', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period', 'timeFrame': 'During the post-marketing study period for Year 1 to Year 6 study period', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.'}]}, 'conditionsModule': {'keywords': ['Gastroenteritis'], 'conditions': ['Infections, Rotavirus']}, 'referencesModule': {'references': [{'pmid': '27494163', 'type': 'DERIVED', 'citation': 'Shin SM, Kim CS, Karkada N, Liu A, Jayadeva G, Han HH. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix). Hum Vaccin Immunother. 2016 Oct 2;12(10):2590-2594. doi: 10.1080/21645515.2016.1189046. Epub 2016 Aug 5.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&parentIdentifier=111700&attachmentIdentifier=979ab41f-0b4f-477f-b016-40716584106a&fileName=gsk-111700-clinical-study-report-redact.pdf&versionIdentifier=', 'label': 'Full CSR posting.'}]}, 'descriptionModule': {'briefSummary': 'This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.', 'detailedDescription': 'The protocol posting has been amended to reflect the two new vaccine presentations that have been launched in Korea. The current PMS will thus collect safety information from subjects who have received either Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) in the course of their routine clinical practice according to the prescribing information in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Weeks', 'minimumAge': '6 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants aged at least 6 weeks will be administered two doses of Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) orally as per the prescribing information in Korea.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS.\n* A male or female infant from the age of 6 weeks at the time of the first vaccination.\n* Written informed consent obtained from the parent or guardian of the infant.\n\nExclusion Criteria:\n\n• At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.'}, 'identificationModule': {'nctId': 'NCT00750893', 'briefTitle': "Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix or Rotarix Liquid Formulation (Oral Suspension or Prefilled Syringe) When Administered According to the Prescribing Information in Korea", 'orgStudyIdInfo': {'id': '111700'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rotarix Group', 'description': 'Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.', 'interventionNames': ['Biological: Rotarix or Rotarix liquid formulation']}], 'interventions': [{'name': 'Rotarix or Rotarix liquid formulation', 'type': 'BIOLOGICAL', 'description': "GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (oral suspension or prefilled syringe).", 'armGroupLabels': ['Rotarix Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '122-896', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}