Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-25 @ 1:40 PM
Study NCT ID:
NCT01106092
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2010-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy 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': 'D006509', 'term': 'Hepatitis B'}, {'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': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales 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': 'Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).', 'eventGroups': [{'id': 'EG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 75, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 74, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 76, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 77, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 57}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 57}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'Anti-polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'Anti-polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '4.72', 'groupDescription': 'To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group \\[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '-3.53', 'ciUpperLimit': '6.94', 'groupDescription': 'To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \\[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '4.72', 'groupDescription': 'To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \\[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '4.78', 'groupDescription': 'To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \\[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '4.72', 'groupDescription': 'To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \\[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '4.72', 'groupDescription': 'To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \\[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '-3.53', 'ciUpperLimit': '6.94', 'groupDescription': 'To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \\[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '-3.53', 'ciUpperLimit': '6.94', 'groupDescription': 'To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \\[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '4.72', 'groupDescription': 'To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \\[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after booster vaccination (At Month 1)', 'description': 'Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'PRIMARY', 'title': 'Anti-polio Types 1, 2 and 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '321.1', 'groupId': 'OG000', 'lowerLimit': '231.2', 'upperLimit': '446.0'}, {'value': '219.1', 'groupId': 'OG001', 'lowerLimit': '144.0', 'upperLimit': '333.6'}, {'value': '296.6', 'groupId': 'OG002', 'lowerLimit': '205.1', 'upperLimit': '428.8'}, {'value': '296.9', 'groupId': 'OG003', 'lowerLimit': '213.9', 'upperLimit': '412.1'}]}]}, {'title': 'Anti-polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '186.8', 'groupId': 'OG000', 'lowerLimit': '140.1', 'upperLimit': '249.2'}, {'value': '152.2', 'groupId': 'OG001', 'lowerLimit': '111.8', 'upperLimit': '207.3'}, {'value': '183.4', 'groupId': 'OG002', 'lowerLimit': '146.4', 'upperLimit': '229.7'}, {'value': '148.0', 'groupId': 'OG003', 'lowerLimit': '112.4', 'upperLimit': '194.9'}]}]}, {'title': 'Anti-polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '74.5', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': '99.0'}, {'value': '82.1', 'groupId': 'OG001', 'lowerLimit': '62.1', 'upperLimit': '108.6'}, {'value': '102.1', 'groupId': 'OG002', 'lowerLimit': '77.6', 'upperLimit': '134.4'}, {'value': '79.1', 'groupId': 'OG003', 'lowerLimit': '57.9', 'upperLimit': '108.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to booster vaccination (At Month 0)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'PRIMARY', 'title': 'Anti-polio Types 1, 2 and 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2218.4', 'groupId': 'OG000', 'lowerLimit': '1786.3', 'upperLimit': '2755.1'}, {'value': '1486.7', 'groupId': 'OG001', 'lowerLimit': '1065.9', 'upperLimit': '2073.5'}, {'value': '1245.1', 'groupId': 'OG002', 'lowerLimit': '1007.2', 'upperLimit': '1539.2'}, {'value': '3760.2', 'groupId': 'OG003', 'lowerLimit': '2973.7', 'upperLimit': '4754.7'}]}]}, {'title': 'Anti-polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1598.8', 'groupId': 'OG000', 'lowerLimit': '1293.5', 'upperLimit': '1976.3'}, {'value': '1056.4', 'groupId': 'OG001', 'lowerLimit': '841.5', 'upperLimit': '1326.1'}, {'value': '966.5', 'groupId': 'OG002', 'lowerLimit': '779.5', 'upperLimit': '1198.3'}, {'value': '2883.2', 'groupId': 'OG003', 'lowerLimit': '2275.2', 'upperLimit': '3653.8'}]}]}, {'title': 'Anti-polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2820', 'groupId': 'OG000', 'lowerLimit': '2129.9', 'upperLimit': '3733.9'}, {'value': '2217.7', 'groupId': 'OG001', 'lowerLimit': '1654', 'upperLimit': '2973.4'}, {'value': '1915.8', 'groupId': 'OG002', 'lowerLimit': '1498.1', 'upperLimit': '2449.8'}, {'value': '3626.4', 'groupId': 'OG003', 'lowerLimit': '2618.2', 'upperLimit': '5022.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after booster vaccination (At Month 1)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}, {'title': 'Anti-polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': 'Anti-polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after booster vaccination (At Month 1)', 'description': 'Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal \\< 8192 ED50): highest dilution tested one month after the booster dose (reciprocal \\> 8192 ED50).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-polio 1', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'Anti-polio 2', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}]}, {'title': 'Anti-polio 3', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to booster vaccination (At Month 0)', 'description': 'Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-D, M0', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Anti-D, M1', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'Anti-T, M0', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}, {'title': 'Anti-T, M1', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Anti-D and Anti-T Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-D, M0', 'categories': [{'measurements': [{'value': '0.301', 'groupId': 'OG000', 'lowerLimit': '0.237', 'upperLimit': '0.382'}, {'value': '0.331', 'groupId': 'OG001', 'lowerLimit': '0.258', 'upperLimit': '0.424'}, {'value': '0.330', 'groupId': 'OG002', 'lowerLimit': '0.264', 'upperLimit': '0.412'}, {'value': '0.374', 'groupId': 'OG003', 'lowerLimit': '0.276', 'upperLimit': '0.508'}]}]}, {'title': 'Anti-D, M1', 'categories': [{'measurements': [{'value': '6.519', 'groupId': 'OG000', 'lowerLimit': '5.46', 'upperLimit': '7.783'}, {'value': '7.687', 'groupId': 'OG001', 'lowerLimit': '6.112', 'upperLimit': '9.669'}, {'value': '8.659', 'groupId': 'OG002', 'lowerLimit': '7.132', 'upperLimit': '10.514'}, {'value': '6.807', 'groupId': 'OG003', 'lowerLimit': '5.231', 'upperLimit': '8.858'}]}]}, {'title': 'Anti-T, M0', 'categories': [{'measurements': [{'value': '0.776', 'groupId': 'OG000', 'lowerLimit': '0.639', 'upperLimit': '0.942'}, {'value': '0.766', 'groupId': 'OG001', 'lowerLimit': '0.622', 'upperLimit': '0.944'}, {'value': '0.833', 'groupId': 'OG002', 'lowerLimit': '0.668', 'upperLimit': '1.038'}, {'value': '0.932', 'groupId': 'OG003', 'lowerLimit': '0.756', 'upperLimit': '1.149'}]}]}, {'title': 'Anti-T, M1', 'categories': [{'measurements': [{'value': '26.12', 'groupId': 'OG000', 'lowerLimit': '22.65', 'upperLimit': '30.121'}, {'value': '31.047', 'groupId': 'OG001', 'lowerLimit': '25.954', 'upperLimit': '37.139'}, {'value': '31.054', 'groupId': 'OG002', 'lowerLimit': '26.837', 'upperLimit': '35.934'}, {'value': '24.402', 'groupId': 'OG003', 'lowerLimit': '21.042', 'upperLimit': '28.298'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-HBs ≥ 3.3 mIU/mL, M0', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}]}, {'title': 'Anti-HBs ≥ 3.3 mIU/mL, M1', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'Anti-HBs ≥ 10 mIU/mL, M0', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}, {'title': 'Anti-HBs ≥ 10 mIU/mL, M1', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to (At Month 0) and one month after the booster vaccination (At Month 1)', 'description': 'Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Anti-HBs Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-HBs, M0', 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000', 'lowerLimit': '40.3', 'upperLimit': '89.1'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '32.8', 'upperLimit': '67.2'}, {'value': '61.9', 'groupId': 'OG002', 'lowerLimit': '42.2', 'upperLimit': '91'}, {'value': '88.5', 'groupId': 'OG003', 'lowerLimit': '60.7', 'upperLimit': '129'}]}]}, {'title': 'Anti-HBs, M1', 'categories': [{'measurements': [{'value': '2713.4', 'groupId': 'OG000', 'lowerLimit': '1846.9', 'upperLimit': '3986.2'}, {'value': '2395.1', 'groupId': 'OG001', 'lowerLimit': '1630', 'upperLimit': '3519.4'}, {'value': '3992.8', 'groupId': 'OG002', 'lowerLimit': '2747.2', 'upperLimit': '5803.1'}, {'value': '3484.3', 'groupId': 'OG003', 'lowerLimit': '2452.2', 'upperLimit': '4950.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (At Month 0) and one month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-PRP, M0', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PRP, M1', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subject for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Anti-PRP Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-PRP, M0', 'categories': [{'measurements': [{'value': '0.134', 'groupId': 'OG000', 'lowerLimit': '0.109', 'upperLimit': '0.166'}, {'value': '0.137', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.172'}, {'value': '0.152', 'groupId': 'OG002', 'lowerLimit': '0.118', 'upperLimit': '0.197'}, {'value': '0.171', 'groupId': 'OG003', 'lowerLimit': '0.13', 'upperLimit': '0.226'}]}]}, {'title': 'Anti-PRP, M1', 'categories': [{'measurements': [{'value': '2.871', 'groupId': 'OG000', 'lowerLimit': '1.797', 'upperLimit': '4.587'}, {'value': '2.243', 'groupId': 'OG001', 'lowerLimit': '1.52', 'upperLimit': '3.31'}, {'value': '1.575', 'groupId': 'OG002', 'lowerLimit': '1.065', 'upperLimit': '2.33'}, {'value': '3.305', 'groupId': 'OG003', 'lowerLimit': '2.373', 'upperLimit': '4.603'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-BPT, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Anti-BPT, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to (At Month 0) and one month after the booster vaccination (At Month 1)', 'description': 'Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Anti-BPT Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-BPT, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '23.6'}, {'value': '20.1', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '24.5'}, {'value': '18.9', 'groupId': 'OG002', 'lowerLimit': '15.9', 'upperLimit': '22.4'}, {'value': '19.5', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '23.9'}]}]}, {'title': 'Anti-BPT, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '161.8', 'groupId': 'OG000', 'lowerLimit': '143.6', 'upperLimit': '182.3'}, {'value': '182.9', 'groupId': 'OG001', 'lowerLimit': '158', 'upperLimit': '211.9'}, {'value': '211', 'groupId': 'OG002', 'lowerLimit': '190.1', 'upperLimit': '234.2'}, {'value': '194.7', 'groupId': 'OG003', 'lowerLimit': '170.6', 'upperLimit': '222.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With a Booster Response for Anti-BPT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after booster vaccination (At Month 1)', 'description': 'Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 8-day (Days 0-7) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'Any Temperature (Axillary)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 8-day (Days 0-7) post-vaccination period', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day (Day 0-Day 30) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'OG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Month 0 to Month 1)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'FG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'FG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'FG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '312', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK2036874A Group 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'BG001', 'title': 'GSK2036874A Group 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'BG002', 'title': 'GSK2036874A Group 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.'}, {'id': 'BG003', 'title': 'Zilbrix/Hib/Poliorix Group', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'spread': '3.81', 'groupId': 'BG000'}, {'value': '18', 'spread': '2.96', 'groupId': 'BG001'}, {'value': '17.7', 'spread': '3.38', 'groupId': 'BG002'}, {'value': '17.5', 'spread': '3.59', 'groupId': 'BG003'}, {'value': '17.65', 'spread': '3.44', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '169', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian-South East Asian heritage', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '312', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'dispFirstSubmitDate': '2010-12-10', 'completionDateStruct': {'date': '2010-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2010-04-01', 'dispFirstSubmitQcDate': '2010-12-10', 'resultsFirstSubmitDate': '2017-03-01', 'studyFirstSubmitQcDate': '2010-04-14', 'dispFirstPostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-01', 'studyFirstPostDateStruct': {'date': '2010-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3', 'timeFrame': 'One month after booster vaccination (At Month 1)', 'description': 'Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.'}, {'measure': 'Anti-polio Types 1, 2 and 3 Antibody Titers', 'timeFrame': 'Prior to booster vaccination (At Month 0)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).'}, {'measure': 'Anti-polio Types 1, 2 and 3 Antibody Titers', 'timeFrame': 'One month after booster vaccination (At Month 1)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).'}], 'secondaryOutcomes': [{'measure': 'Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3', 'timeFrame': 'One month after booster vaccination (At Month 1)', 'description': 'Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal \\< 8192 ED50): highest dilution tested one month after the booster dose (reciprocal \\> 8192 ED50).'}, {'measure': 'Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3', 'timeFrame': 'Prior to booster vaccination (At Month 0)', 'description': 'Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.'}, {'measure': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).'}, {'measure': 'Anti-D and Anti-T Antibody Concentrations', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.'}, {'measure': 'Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)', 'timeFrame': 'Prior to (At Month 0) and one month after the booster vaccination (At Month 1)', 'description': 'Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.'}, {'measure': 'Anti-HBs Antibody Concentrations', 'timeFrame': 'Prior to (At Month 0) and one month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.'}, {'measure': 'Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)', 'timeFrame': 'Prior to (At Month 0) and one month after the booster vaccination (At Month 1)', 'description': 'Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).'}, {'measure': 'Anti-BPT Antibody Concentrations', 'timeFrame': 'Prior to (At Month 0) and one month after booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.'}, {'measure': 'Number of Subjects With a Booster Response for Anti-BPT', 'timeFrame': 'One month after booster vaccination (At Month 1)', 'description': 'Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.'}, {'measure': 'Number of Subjects With Any Solicited Local Symptoms', 'timeFrame': 'During the 8-day (Days 0-7) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.'}, {'measure': 'Number of Subjects With Any Solicited General Symptoms', 'timeFrame': 'During the 8-day (Days 0-7) post-vaccination period', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 31-day (Day 0-Day 30) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period (from Month 0 to Month 1)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}]}, 'conditionsModule': {'conditions': ['Haemophilus Influenzae Type b', 'Tetanus', 'Hepatitis B', 'Whole Cell Pertussis', 'Diphtheria', 'Poliomyelitis Vaccines']}, 'referencesModule': {'availIpds': [{'id': '113264', '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': '113264', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113264', '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': '113264', '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': '113264', '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': '113264', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113264', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '22330958', 'type': 'BACKGROUND', 'citation': 'Quiambao B, Van Der Meeren O, Kolhe D, Gatchalian S. A randomized, dose-ranging assessment of the immunogenicity and safety of a booster dose of a combined diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzae type b (DTPw-HBV-IPV/Hib) vaccine vs. co-administration of DTPw-HBV/Hib and IPV vaccines in 12 to 24 months old Filipino toddlers. Hum Vaccin Immunother. 2012 Mar;8(3):347-54. doi: 10.4161/hv.18630. Epub 2012 Feb 14.'}, {'type': 'BACKGROUND', 'citation': 'Quiambao B et al. The immunogenicity and safety of a new combined DTPw-HBV-IPV/HIB vaccine when administered as a booster dose in Filipino toddlers. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID), Melbourne, Australia, 16-19 November 2011.'}], '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 the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.", 'detailedDescription': 'The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.\n* Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.\n* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.\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\nExclusion Criteria:\n\n* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.\n* Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).\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* History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.\n* Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n* A family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or serious chronic illness.\n* History of neurologic disorders or seizures.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.\n* Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.\n* Child in care.\n* Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:\n\n * encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,\n * fever \\>= 40 °C within 48 hours of vaccination not due to another identifiable cause,\n * collapse or shock-like state within 48 hours of vaccination,\n * convulsions with or without fever, occurring within 3 days of vaccination.\n* Acute disease and/or fever at the time of enrolment.\n\n * Fever is defined as temperature \\>= 37.5°C on oral, axillary or tympanic setting, or \\>= 38.0°C on rectal setting.\n * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.\n* Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.'}, 'identificationModule': {'nctId': 'NCT01106092', 'briefTitle': 'Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers", 'orgStudyIdInfo': {'id': '113264'}, 'secondaryIdInfos': [{'id': '2016-000645-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK2036874A GROUP 1', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.', 'interventionNames': ['Biological: GSK2036874A vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'GSK2036874A GROUP 2', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.', 'interventionNames': ['Biological: GSK2036874A vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'GSK2036874A GROUP 3', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.', 'interventionNames': ['Biological: GSK2036874A vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ZILBRIX/HIB/POLIORIX GROUP', 'description': 'Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.', 'interventionNames': ['Biological: Zilbrix™/Hib vaccine', 'Biological: Poliorix™']}], 'interventions': [{'name': 'GSK2036874A vaccine', 'type': 'BIOLOGICAL', 'description': 'Intramuscular, single dose', 'armGroupLabels': ['GSK2036874A GROUP 1', 'GSK2036874A GROUP 2', 'GSK2036874A GROUP 3']}, {'name': 'Zilbrix™/Hib vaccine', 'type': 'BIOLOGICAL', 'description': 'Intramuscular, single dose', 'armGroupLabels': ['ZILBRIX/HIB/POLIORIX GROUP']}, {'name': 'Poliorix™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular, single dose', 'armGroupLabels': ['ZILBRIX/HIB/POLIORIX GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1781', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}], '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'}}}}