Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT01353703
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2011-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative 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': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 to Month 3 or Month 5).', 'eventGroups': [{'id': 'EG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 45, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 36, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 46, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Hepatitis B (HBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-Polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-PT, S-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PT, S+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, S-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, S+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN, S-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN, S+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed and for whom pre-vaccination data was available for the considered assay.'}, {'type': 'SECONDARY', 'title': 'Anti-D and Anti-T Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '2.334', 'groupId': 'OG000', 'lowerLimit': '2.049', 'upperLimit': '2.659'}, {'value': '3.726', 'groupId': 'OG001', 'lowerLimit': '3.26', 'upperLimit': '4.258'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '3.307', 'groupId': 'OG000', 'lowerLimit': '2.925', 'upperLimit': '3.739'}, {'value': '4.904', 'groupId': 'OG001', 'lowerLimit': '4.378', 'upperLimit': '5.493'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Anti-HBs Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '1695.7', 'groupId': 'OG000', 'lowerLimit': '1395.2', 'upperLimit': '2060.9'}, {'value': '3314.5', 'groupId': 'OG001', 'lowerLimit': '2645.2', 'upperLimit': '4153.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Anti-Polio Types 1, 2, 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-Polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '884.3', 'groupId': 'OG000', 'lowerLimit': '666.6', 'upperLimit': '1173.1'}, {'value': '1799.2', 'groupId': 'OG001', 'lowerLimit': '1429', 'upperLimit': '2265.5'}]}]}, {'title': 'Anti-Polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '840.2', 'groupId': 'OG000', 'lowerLimit': '616.9', 'upperLimit': '1144.2'}, {'value': '2138.7', 'groupId': 'OG001', 'lowerLimit': '1658.1', 'upperLimit': '2758.7'}]}]}, {'title': 'Anti-Polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '923.7', 'groupId': 'OG000', 'lowerLimit': '691.9', 'upperLimit': '1233.2'}, {'value': '2245.5', 'groupId': 'OG001', 'lowerLimit': '1866.1', 'upperLimit': '2702.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', '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 According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Anti-PRP Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.697', 'groupId': 'OG000', 'lowerLimit': '2.176', 'upperLimit': '3.343'}, {'value': '5.404', 'groupId': 'OG001', 'lowerLimit': '4.168', 'upperLimit': '7.006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', '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 According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '107.3', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '119.1'}, {'value': '108.2', 'groupId': 'OG001', 'lowerLimit': '97.4', 'upperLimit': '120.2'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '293.7', 'groupId': 'OG000', 'lowerLimit': '259.4', 'upperLimit': '332.6'}, {'value': '369.3', 'groupId': 'OG001', 'lowerLimit': '335.5', 'upperLimit': '406.5'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '224.4', 'groupId': 'OG000', 'lowerLimit': '194.2', 'upperLimit': '259.3'}, {'value': '243.6', 'groupId': 'OG001', 'lowerLimit': '213.2', 'upperLimit': '278.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', '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 According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-Polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 0', 'description': 'A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 0', 'description': 'A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Anti-HBs Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 0', 'description': 'A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Anti-Polio Types 1, 2 and 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-Polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '33.5', 'upperLimit': '85.3'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '47.2'}]}]}, {'title': 'Anti-Polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '55'}, {'value': '36.2', 'groupId': 'OG001', 'lowerLimit': '22.2', 'upperLimit': '59'}]}]}, {'title': 'Anti-Polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '10.8'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '17'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '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 According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '6'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '5.6'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '23.3'}, {'value': '20.1', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '25.2'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '3.9'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 0', '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 According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Anti-HBs Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '8.3'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '7.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 0', '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 According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Across doses', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Across doses', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Across doses', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine, for whom data were available and who had the symptoms sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'title': 'Any Drowsiness, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability/fussiness, Dose 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Dose 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature/(Axillary), Dose 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability/fussiness, Dose 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature/(Axillary), Dose 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness, Dose 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability/fussiness, Dose 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Dose 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature/(Axillary), Dose 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness, Across doses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability/fussiness, Across doses', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Across doses', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature/(Axillary), Across doses', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)', 'description': 'Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine, for whom data were available and who had the symptoms sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)', '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 subjects who received at least one dose of the study vaccine and for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))', '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 subjects who received at least one dose of the study vaccine and for whom data were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'FG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], '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': '112', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Infanrix Hexa 6-10-14 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'BG001', 'title': 'Infanrix Hexa 2-4-6 Group', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '1.04', 'groupId': 'BG000'}, {'value': '6.8', 'spread': '1.13', 'groupId': 'BG001'}, {'value': '6.75', 'spread': '1.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian-Central/South Asian heritage', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2013-04-18', 'completionDateStruct': {'date': '2013-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-27', 'studyFirstSubmitDate': '2011-05-12', 'dispFirstSubmitQcDate': '2013-04-18', 'resultsFirstSubmitDate': '2017-05-26', 'studyFirstSubmitQcDate': '2011-05-12', 'dispFirstPostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-30', 'studyFirstPostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).'}, {'measure': 'Number of Seroprotected Subjects Against Hepatitis B (HBs)', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).'}, {'measure': 'Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).'}, {'measure': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).'}, {'measure': 'Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.'}], 'secondaryOutcomes': [{'measure': 'Anti-D and Anti-T Antibody Concentrations', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).'}, {'measure': 'Anti-HBs Antibody Concentrations', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Anti-Polio Types 1, 2, 3 Antibody Titers', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.'}, {'measure': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.'}, {'measure': 'Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN', 'timeFrame': 'One month post Dose 3 (Month 3 or Month 5)', 'description': 'A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens', 'timeFrame': 'At Month 0', 'description': 'A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).'}, {'measure': 'Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN', 'timeFrame': 'At Month 0', 'description': 'A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Anti-HBs Antigens', 'timeFrame': 'At Month 0', 'description': 'A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.'}, {'measure': 'Anti-Polio Types 1, 2 and 3 Antibody Titers', 'timeFrame': 'At Month 0', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).'}, {'measure': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'timeFrame': 'At Month 0', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.'}, {'measure': 'Anti-HBs Antibody Concentrations', 'timeFrame': 'At Month 0', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.'}, {'measure': 'Number of Subjects With Any Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)', 'description': 'Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)', '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 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))', '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': ['Infanrix hexa™', 'Primary vaccination', 'India', 'combination vaccine', 'infants'], 'conditions': ['Poliomyelitis', 'Tetanus', 'Acellular Pertussis', 'Haemophilus Influenzae Type b', 'Diphtheria', 'Hepatitis B', 'Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines']}, 'referencesModule': {'availIpds': [{'id': '111157', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111157', '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': '111157', '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': '111157', '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': '111157', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111157', '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': '27629913', 'type': 'BACKGROUND', 'citation': 'Lalwani SK, Agarkhedkar S, Sundaram B, Mahantashetti NS, Malshe N, Agarkhedkar S, Van Der Meeren O, Mehta S, Karkada N, Han HH, Mesaros N. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants. Hum Vaccin Immunother. 2017 Jan 2;13(1):120-127. doi: 10.1080/21645515.2016.1225639. Epub 2016 Sep 15.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects must satisfy ALL the following criteria at study entry:\n\n* A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination\n* Documented administration of a hepatitis B vaccine dose at birth\n* Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) \\[LAR(s)\\] can and will comply with the requirements of the protocol\n* Written informed consent obtained from the parent(s)/LAR(s) of the subject\n* Healthy subjects as established by medical history and clinical examination before entering into the study\n* Born after a gestation period of at least 36 weeks\n\nExclusion Criteria:\n\nThe following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:\n\n* Child in care\n* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose\n* Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product\n* Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination\n* Family history of congenital or hereditary immunodeficiency\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine\n* Major congenital defects or serious chronic illness\n* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period\n* Acute disease and/or fever at the time of enrolment'}, 'identificationModule': {'nctId': 'NCT01353703', 'briefTitle': "Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India", 'orgStudyIdInfo': {'id': '111157'}, 'secondaryIdInfos': [{'id': '2013-003427-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INFANRIX HEXA 6-10-14 GROUP', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.', 'interventionNames': ['Biological: Infanrix hexa™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'INFANRIX HEXA 2-4-6 GROUP', 'description': 'Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.', 'interventionNames': ['Biological: Infanrix hexa™']}], 'interventions': [{'name': 'Infanrix hexa™', 'type': 'BIOLOGICAL', 'otherNames': ['DTPa-HBV-IPV/Hib'], 'description': 'Intramuscular, three doses', 'armGroupLabels': ['INFANRIX HEXA 2-4-6 GROUP', 'INFANRIX HEXA 6-10-14 GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '590010', 'city': 'Belgaun', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.92807, 'lon': 86.15753}}, {'city': 'Chennai', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '411018', 'city': 'Pune', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Pune', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=4632', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}