Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-04-14 @ 12:53 AM
Study NCT ID:
NCT00473668
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2007-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D014917', 'term': 'Whooping Cough'}], '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': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales 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': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C514867', 'term': 'Hiberix'}]}}, '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 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).', 'eventGroups': [{'id': 'EG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 87, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 84, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 81, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Redness (mm)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Swelling (mm)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 76}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fever (Axillary)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in anti-PRP SPR rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-6.39', 'ciUpperLimit': '2.84', 'groupDescription': 'Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\\<) 10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in anti-PRP SPR rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-4.16', 'ciUpperLimit': '3.99', 'groupDescription': 'Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\\<) 10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 3', 'description': 'A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 3', 'description': 'A seroprotected subject is defined as a vaccinated subject with anti-hepatitis B antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 3', 'description': 'A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Seroprotection was assesed via enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 3', 'description': 'Seroprotection cut-off values assessed were greater than or equal to (≥) 0.016 international units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination. Concentrations were assessed via neutralization assay on Vero cells.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 3', 'description': 'Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 3', 'description': 'A seropositive subject was defined as a vaccinated subject with anti-BPT antibody concentration greater than or equal to (≥) 15 ELISA units (EL.U) per milliliter (EL.U/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 3', 'description': 'Vaccine response was defined as: for initially seronegative subjects, antibody concentration greater than or equal to (≥) 15 EL.U/mL; and for initially seropositive subjects, antibody concentration ≥ 1 fold the pre-vaccination antibody concentration.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB/Hiberix Kft. 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[{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 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'groupId': 'OG002'}]}]}, {'title': 'Any Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, 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'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Any Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Any Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 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'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, 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'10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Fever, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day (Day 0-3) follow-up period post-vaccination', 'description': 'Assessed solicited general symptoms were drowsiness, fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], irritability and loss of appetite. 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Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 31-day (Day 0-30) follow-up period post-vaccination', '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. 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Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'OG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (Day 0-Month 3)', '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': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'FG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'FG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Out of 300 subjects enrolled in the study, one did not receive any vaccination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tritanrix-HepB/Hiberix Kft. Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'BG001', 'title': 'Tritanrix-HepB/Hiberix LD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'BG002', 'title': 'Tritanrix-HepB/Hiberix HD Group', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '0.59', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '0.64', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '0.51', 'groupId': 'BG002'}, {'value': '6.3', 'spread': '0.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2009-05-20', 'completionDateStruct': {'date': '2008-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2007-05-14', 'dispFirstSubmitQcDate': '2009-09-28', 'resultsFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2007-05-14', 'dispFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-17', 'studyFirstPostDateStruct': {'date': '2007-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens', 'timeFrame': 'At Month 3', 'description': 'A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).'}], 'secondaryOutcomes': [{'measure': 'Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)', 'timeFrame': 'At Month 3', 'description': 'A seroprotected subject is defined as a vaccinated subject with anti-hepatitis B antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).'}, {'measure': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen', 'timeFrame': 'At Month 3', 'description': 'A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Seroprotection was assesed via enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off', 'timeFrame': 'At Month 3', 'description': 'Seroprotection cut-off values assessed were greater than or equal to (≥) 0.016 international units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination. Concentrations were assessed via neutralization assay on Vero cells.'}, {'measure': 'Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens', 'timeFrame': 'At Month 3', 'description': 'Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL).'}, {'measure': 'Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen', 'timeFrame': 'At Month 3', 'description': 'A seropositive subject was defined as a vaccinated subject with anti-BPT antibody concentration greater than or equal to (≥) 15 ELISA units (EL.U) per milliliter (EL.U/mL).'}, {'measure': 'Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen', 'timeFrame': 'At Month 3', 'description': 'Vaccine response was defined as: for initially seronegative subjects, antibody concentration greater than or equal to (≥) 15 EL.U/mL; and for initially seropositive subjects, antibody concentration ≥ 1 fold the pre-vaccination antibody concentration.'}, {'measure': 'Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens', 'timeFrame': 'At Month 3', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).'}, {'measure': 'Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens', 'timeFrame': 'At Month 3', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).'}, {'measure': 'Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)', 'timeFrame': 'At Month 3', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen', 'timeFrame': 'At Month 3', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Day 0-3) follow-up period post-vaccination', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 4-day (Day 0-3) follow-up period post-vaccination', 'description': 'Assessed solicited general symptoms were drowsiness, fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], irritability and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade. Grade 3 Irritability= crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness/Loss of appetite= Drowsiness/Loss of appetite that prevented normal activity. Grade 3 fever = fever above (\\>) 39.5°C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 31-day (Day 0-30) follow-up period post-vaccination', '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 (Day 0-Month 3)', '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': {'keywords': ['Hepatitis B', 'Tetanus', 'Diphtheria', 'Pertussis', 'Haemophilus influenzae type b Vaccines'], 'conditions': ['Whole Cell Pertussis', 'Haemophilus Influenzae Type b', 'Tetanus', 'Diphtheria', 'Hepatitis B']}, 'referencesModule': {'availIpds': [{'id': '104977', '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': '104977', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104977', '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': '104977', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104977', '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': '104977', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '20950457', 'type': 'BACKGROUND', 'citation': "Chatterjee S, Rego SJ, D'Souza F, Bhatia BD, Collard A, Datta SK, Jacquet JM. The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule. BMC Infect Dis. 2010 Oct 15;10:298. doi: 10.1186/1471-2334-10-298."}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.\n* A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.\n* Written informed consent obtained from the parent or guardian of the subject.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Born after a gestation period of 36 to 42 weeks inclusive.\n* Administration of one dose of hepatitis B vaccine at birth\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period with the exception of OPV.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV).\n* Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.\n* Hepatitis B vaccine received after the first week of life.\n* Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth).\n* History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B 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* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).\n* Major congenital defects or serious chronic illness.\n* History of any neurologic disorders or seizures.\n* Acute disease at the time of enrolment.\n* Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.\n* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.'}, 'identificationModule': {'nctId': 'NCT00473668', 'briefTitle': "Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age", 'orgStudyIdInfo': {'id': '104977'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRITANRIX-HEPB/HIBERIX KFT. GROUP', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.', 'interventionNames': ['Biological: Zilbrix-Hib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRITANRIX-HEPB/HIBERIX LD GROUP', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.', 'interventionNames': ['Biological: Tritanrix™-HepB/ Hiberix™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRITANRIX-HEPB/HIBERIX HD GROUP', 'description': 'Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.', 'interventionNames': ['Biological: Tritanrix™-HepB/ Hiberix™']}], 'interventions': [{'name': 'Zilbrix-Hib', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 1 dose', 'armGroupLabels': ['TRITANRIX-HEPB/HIBERIX KFT. GROUP']}, {'name': 'Tritanrix™-HepB/ Hiberix™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 1 dose', 'armGroupLabels': ['TRITANRIX-HEPB/HIBERIX HD GROUP', 'TRITANRIX-HEPB/HIBERIX LD GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560034', 'city': 'Bangalore', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '700072', 'city': 'Kolkotta', 'country': 'India', 'facility': 'GSK Investigational Site'}, {'zip': '221005', 'city': 'Varanasi', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}], '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'}}}}