Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT00158756
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D013742', 'term': 'Tetanus'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003015', 'term': 'Clostridium Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C492457', 'term': 'RIX4414 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 local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4', 'eventGroups': [{'id': 'EG000', 'title': 'Tritanrix™-HepB+Rotarix™ Group', 'description': 'Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.', 'otherNumAtRisk': 80, 'otherNumAffected': 74, 'seriousNumAtRisk': 80, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Tritanrix™-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Zilbrix™+Rotarix™ Group', 'description': 'Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.', 'otherNumAtRisk': 81, 'otherNumAffected': 74, 'seriousNumAtRisk': 81, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Zilbrix™+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.', 'otherNumAtRisk': 23, 'otherNumAffected': 22, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Triple Antigen™+Engerix™-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.', 'otherNumAtRisk': 99, 'otherNumAffected': 96, 'seriousNumAtRisk': 99, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 76, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 76, 'numAffected': 65}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 77}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 76, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 80}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 84}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laryngotracheitis obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Overgrowth bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '83.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '80.5', 'upperLimit': '100'}, {'value': '98.9', 'groupId': 'OG004', 'lowerLimit': '93.8', 'upperLimit': '100'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis were performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At one most post dose 3 [PIII(M4)]', 'description': 'A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Vaccine Response to BPT Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 2.5 months after dose 2 of Rotarix [PIII(M4)]', 'description': 'A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'title': 'Anti-Polio 1, [N=54,17,47,14,72]', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}]}, {'title': 'Anti-Polio 2, [N=58,18,57,14,79]', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}]}, {'title': 'Anti-Polio 3, [N=57,18,55,15,79]', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Anti-HBs Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '600.5', 'groupId': 'OG000', 'lowerLimit': '473.1', 'upperLimit': '762.3'}, {'value': '732.7', 'groupId': 'OG001', 'lowerLimit': '472.0', 'upperLimit': '1137.3'}, {'value': '789.8', 'groupId': 'OG002', 'lowerLimit': '626.8', 'upperLimit': '995.1'}, {'value': '850.6', 'groupId': 'OG003', 'lowerLimit': '527.7', 'upperLimit': '1371.2'}, {'value': '578.6', 'groupId': 'OG004', 'lowerLimit': '442.3', 'upperLimit': '757.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured 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 included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Anti-DT Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.667', 'groupId': 'OG000', 'lowerLimit': '0.517', 'upperLimit': '0.862'}, {'value': '0.545', 'groupId': 'OG001', 'lowerLimit': '0.276', 'upperLimit': '1.078'}, {'value': '0.957', 'groupId': 'OG002', 'lowerLimit': '0.725', 'upperLimit': '1.262'}, {'value': '0.906', 'groupId': 'OG003', 'lowerLimit': '0.569', 'upperLimit': '1.444'}, {'value': '1.096', 'groupId': 'OG004', 'lowerLimit': '0.869', 'upperLimit': '1.381'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in 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 included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Anti-T Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.138', 'groupId': 'OG000', 'lowerLimit': '2.580', 'upperLimit': '3.817'}, {'value': '3.350', 'groupId': 'OG001', 'lowerLimit': '2.173', 'upperLimit': '5.164'}, {'value': '3.737', 'groupId': 'OG002', 'lowerLimit': '3.079', 'upperLimit': '4.535'}, {'value': '5.323', 'groupId': 'OG003', 'lowerLimit': '3.411', 'upperLimit': '8.306'}, {'value': '3.319', 'groupId': 'OG004', 'lowerLimit': '2.838', 'upperLimit': '3.881'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (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 included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Anti-BPT Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'groupId': 'OG000', 'lowerLimit': '57.9', 'upperLimit': '74.5'}, {'value': '50.8', 'groupId': 'OG001', 'lowerLimit': '36.5', 'upperLimit': '70.6'}, {'value': '40.1', 'groupId': 'OG002', 'lowerLimit': '33.8', 'upperLimit': '47.5'}, {'value': '37.2', 'groupId': 'OG003', 'lowerLimit': '25.6', 'upperLimit': '54.3'}, {'value': '38.0', 'groupId': 'OG004', 'lowerLimit': '32.5', 'upperLimit': '44.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured 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 included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Anti-RV Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '57.5', 'upperLimit': '161.8'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '93.1', 'groupId': 'OG002', 'lowerLimit': '56.1', 'upperLimit': '154.3'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '10.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 2.5 months post dose 2 of Rotarix [PIII(M4)]', 'description': 'Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.', 'unitOfMeasure': 'U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.lysis'}, {'type': 'SECONDARY', 'title': 'Anti-Polio Type 1, 2, 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'title': 'Anti-Polio 1, [N=54,17,47,14,72]', 'categories': [{'measurements': [{'value': '900.7', 'groupId': 'OG000', 'lowerLimit': '643.1', 'upperLimit': '1261.5'}, {'value': '1181.0', 'groupId': 'OG001', 'lowerLimit': '604.4', 'upperLimit': '2307.7'}, {'value': '877.7', 'groupId': 'OG002', 'lowerLimit': '612.3', 'upperLimit': '1257.9'}, {'value': '779.9', 'groupId': 'OG003', 'lowerLimit': '391.3', 'upperLimit': '1554.1'}, {'value': '1155.0', 'groupId': 'OG004', 'lowerLimit': '877.8', 'upperLimit': '1519.7'}]}]}, {'title': 'Anti-Polio 2, [N=58,18,57,14,79]', 'categories': [{'measurements': [{'value': '811.2', 'groupId': 'OG000', 'lowerLimit': '655.3', 'upperLimit': '1004.1'}, {'value': '1024.0', 'groupId': 'OG001', 'lowerLimit': '679.8', 'upperLimit': '1542.2'}, {'value': '774.2', 'groupId': 'OG002', 'lowerLimit': '602.4', 'upperLimit': '994.9'}, {'value': '882.6', 'groupId': 'OG003', 'lowerLimit': '538.2', 'upperLimit': '1447.4'}, {'value': '825.9', 'groupId': 'OG004', 'lowerLimit': '661.7', 'upperLimit': '1031.0'}]}]}, {'title': 'Anti-Polio 3, [N=57,18,55,15,79]', 'categories': [{'measurements': [{'value': '326.6', 'groupId': 'OG000', 'lowerLimit': '234.7', 'upperLimit': '454.3'}, {'value': '369.1', 'groupId': 'OG001', 'lowerLimit': '163.6', 'upperLimit': '832.8'}, {'value': '313.3', 'groupId': 'OG002', 'lowerLimit': '240.8', 'upperLimit': '407.7'}, {'value': '330.3', 'groupId': 'OG003', 'lowerLimit': '185.4', 'upperLimit': '588.4'}, {'value': '351.3', 'groupId': 'OG004', 'lowerLimit': '267.5', 'upperLimit': '461.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Anti-Polio type 1, 2 and 3 antibody titers were expressed 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 included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '98', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'title': 'Any Pain, Dose 1 [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain, Dose 1 [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness, Dose 1 [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness, Dose 1 [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling, Dose 1 [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling, Dose 1 [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Any Pain, Dose 2 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain, Dose 2 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness, Dose 2 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness, Dose 2 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling, Dose 2 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling, Dose 2 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Any Pain, Dose 3 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain, Dose 3 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness, Dose 3 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness, Dose 3 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling, Dose 3 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling, Dose 3 [N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Any Pain, Across [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain, Across [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness, Across [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '77', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness, Across [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling, Across [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling, Across [N=78;25;76;23;98]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 8-Day (Days 0-7) follow-up period', 'description': 'Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '98', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'title': 'Any Diarrhea, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Diarrhea, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Diarrhea, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Any Drowsiness, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Related Drowsiness, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}]}, {'title': 'Any Fever, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Fever, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Related Fever, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}]}]}, {'title': 'Any Irritability, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Irritability, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Related Irritability, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}]}, {'title': 'Any Loss of appet., Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Loss of appet., Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Related Loss of appet., Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}]}, {'title': 'Any Vomiting, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Vomiting, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Related Vomiting, Dose 1[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Any Diarrhea, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Diarrhea, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Diarrhea, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any Drowsiness, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Related Drowsiness, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}]}, {'title': 'Any Fever, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Fever, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Related Fever, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}]}, {'title': 'Any Irritability, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Irritability, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Related Irritability, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}]}, {'title': 'Any Loss of appet., Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Loss of appet., Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Related Loss of appet., Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}]}, {'title': 'Any Vomiting, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Vomiting, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Related Vomiting, Dose 2[N=76;25;75;22;96]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Any Diarrhea, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Diarrhea, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Diarrhea, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Drowsiness, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Drowsiness, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}]}, {'title': 'Any Fever, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Fever, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Related Fever, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}, {'title': 'Any Irritability, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Irritability, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Related Irritability, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}]}, {'title': 'Any Loss of appet., Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Loss of appet., Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Loss of appet., Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Any Vomiting, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Vomiting, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Vomiting, Dose 3[N=76;25;73;22;96]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Any Diarrhea, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Diarrhea, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Diarrhea, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Any Drowsiness, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Drowsiness, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Related Drowsiness, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}]}, {'title': 'Any Fever, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Fever, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Related Fever, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '78', 'groupId': 'OG004'}]}]}, {'title': 'Any Irritability, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Irritability, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Related Irritability, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}]}]}, {'title': 'Any Loss of appet., Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Loss of appet., Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Related Loss of appet., Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}]}, {'title': 'Any Vomiting, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Vomiting, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Related Vomiting, Across[N=78;25;77;23;98]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 8-day period (Days 0-7) post-vaccination', 'description': 'Assessed solicited general symptoms were diarrhea, drowsiness, fever \\[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\\], irritability, loss of appetite \\[loss of appet.\\] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 31-day (Days 0-30) follow-up period', 'description': 'Number of subjects with any unsolicited adverse events (AEs)\n\nAn 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': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'OG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 0 to Month 4', '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 analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'FG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'FG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'FG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'FG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '81'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '73'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Tritanrix-HepB+Rotarix Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'BG001', 'title': 'Tritanrix-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'BG002', 'title': 'Zilbrix+Rotarix Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'BG003', 'title': 'Zilbrix+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.'}, {'id': 'BG004', 'title': 'Triple Antigen+Engerix-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '1.70', 'groupId': 'BG000'}, {'value': '13.4', 'spread': '1.87', 'groupId': 'BG001'}, {'value': '12.8', 'spread': '1.39', 'groupId': 'BG002'}, {'value': '12.8', 'spread': '1.56', 'groupId': 'BG003'}, {'value': '12.9', 'spread': '1.33', 'groupId': 'BG004'}, {'value': '12.93', 'spread': '1.51', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '152', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '156', 'groupId': 'BG005'}]}]}], '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': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2006-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2005-09-08', 'resultsFirstSubmitDate': '2016-12-20', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-14', 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.'}], 'secondaryOutcomes': [{'measure': 'Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.'}, {'measure': 'Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies', 'timeFrame': 'At one most post dose 3 [PIII(M4)]', 'description': 'A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).'}, {'measure': 'Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).'}, {'measure': 'Number of Subjects With Vaccine Response to BPT Antigen', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.'}, {'measure': 'Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values', 'timeFrame': 'At 2.5 months after dose 2 of Rotarix [PIII(M4)]', 'description': 'A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).'}, {'measure': 'Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).'}, {'measure': 'Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8'}, {'measure': 'Concentrations of Anti-HBs Antibodies', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.'}, {'measure': 'Concentrations of Anti-DT Antibodies', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.'}, {'measure': 'Concentrations of Anti-T Antibodies', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).'}, {'measure': 'Concentrations of Anti-BPT Antibodies', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.'}, {'measure': 'Concentrations of Anti-RV Antibodies', 'timeFrame': 'At 2.5 months post dose 2 of Rotarix [PIII(M4)]', 'description': 'Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.'}, {'measure': 'Anti-Polio Type 1, 2, 3 Antibody Titers', 'timeFrame': 'At one month post dose 3 [PIII(M4)]', 'description': 'Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Subjects With Solicited Local Symptoms', 'timeFrame': 'During the 8-Day (Days 0-7) follow-up period', 'description': 'Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).'}, {'measure': 'Number of Subjects With Any Solicited General Symptoms', 'timeFrame': 'During the 8-day period (Days 0-7) post-vaccination', 'description': 'Assessed solicited general symptoms were diarrhea, drowsiness, fever \\[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\\], irritability, loss of appetite \\[loss of appet.\\] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 31-day (Days 0-30) follow-up period', 'description': 'Number of subjects with any unsolicited adverse events (AEs)\n\nAn 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': 'From Month 0 to Month 4', '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': ['Diphtheria', 'Pertussis', 'Prophylaxis', 'Hepatitis B diseases', 'Tetanus'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'availIpds': [{'id': '104021', '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': '104021', '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': '104021', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104021', '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': '104021', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104021', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], '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': "To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.", 'detailedDescription': "Randomized study with five groups to receive one of the following vaccination regimens:\n\nOne of the two formulations of GSK Biologicals' DTPw-HBV + GSK Biologicals' HRV One of the two formulations of GSK Biologicals' DTPw-HBV + Placebo CSL's DTPw + GSK Biologicals' HBV"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '3 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.\n* Administration of one dose of hepatitis B vaccine at birth.\n* A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n\nExclusion criteria:\n\n* Use of any investigational or non-registered product (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.\n* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)\n* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.'}, 'identificationModule': {'nctId': 'NCT00158756', 'briefTitle': 'Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "A Phase III, Partially Blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB and GSK Biologicals Kft's DTPw-HBV Vaccines as Compared to Concomitant Administration of Commonwealth Serum Laboratory's (CSL's) DTPw (Triple Antigen™) and GSK Biologicals' HBV (Engerix™-B), When Co-administered With GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, to Healthy Infants at 3, 4½ and 6 Months of Age, After a Birth Dose of Hepatitis B Vaccine.", 'orgStudyIdInfo': {'id': '104021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tritanrix™-HepB+Rotarix™ Group', 'description': 'Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.', 'interventionNames': ['Biological: Tritanrix™-HepB', 'Biological: Rotarix™']}, {'type': 'EXPERIMENTAL', 'label': 'Tritanrix™-HepB+Placebo Group', 'description': 'Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.', 'interventionNames': ['Biological: Tritanrix™-HepB', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zilbrix™+Rotarix™ Group', 'description': 'Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.', 'interventionNames': ['Biological: Rotarix™', 'Biological: Zilbrix™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zilbrix™+Placebo Group', 'description': 'Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.', 'interventionNames': ['Biological: Zilbrix™', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triple Antigen™+Engerix™-B Group', 'description': 'Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.', 'interventionNames': ['Biological: Triple Antigen™', 'Biological: Engerix™-B']}], 'interventions': [{'name': 'Tritanrix™-HepB', 'type': 'BIOLOGICAL', 'otherNames': ['DTPw-HBV'], 'description': "GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.", 'armGroupLabels': ['Tritanrix™-HepB+Placebo Group', 'Tritanrix™-HepB+Rotarix™ Group']}, {'name': 'Rotarix™', 'type': 'BIOLOGICAL', 'otherNames': ['HRV vaccine'], 'description': "GSK Biologicals' live attenuated human rotavirus vaccine", 'armGroupLabels': ['Tritanrix™-HepB+Rotarix™ Group', 'Zilbrix™+Rotarix™ Group']}, {'name': 'Zilbrix™', 'type': 'BIOLOGICAL', 'otherNames': ['DTPw-HBV Kft'], 'description': "GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine", 'armGroupLabels': ['Zilbrix™+Placebo Group', 'Zilbrix™+Rotarix™ Group']}, {'name': 'Triple Antigen™', 'type': 'BIOLOGICAL', 'otherNames': ['DTPwcsl vaccine'], 'description': "Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.", 'armGroupLabels': ['Triple Antigen™+Engerix™-B Group']}, {'name': 'Engerix™-B', 'type': 'BIOLOGICAL', 'otherNames': ['HBV vaccine'], 'description': "GSK Biologicals' hepatitis B vaccine", 'armGroupLabels': ['Triple Antigen™+Engerix™-B Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for the Rotarix™ vaccine', 'armGroupLabels': ['Tritanrix™-HepB+Placebo Group', 'Zilbrix™+Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '656049', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '141280', 'city': 'Ivanteevka Moscow Region', 'country': 'Russia', 'facility': 'GSK Investigational Site'}, {'zip': '660027', 'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129347', 'city': 'Moscow', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443021', 'city': 'Samara', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '634 050', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '620003', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], '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'}}}}