Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT00136604
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2005-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}], 'ancestors': [{'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000610192', 'term': 'PsACWY 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 symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).', 'eventGroups': [{'id': 'EG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.', 'otherNumAtRisk': 249, 'deathsNumAtRisk': 249, 'otherNumAffected': 234, 'seriousNumAtRisk': 249, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm', 'otherNumAtRisk': 123, 'deathsNumAtRisk': 123, 'otherNumAffected': 115, 'seriousNumAtRisk': 123, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 75, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 38, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 113, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 130, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 54, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 57, 'numAffected': 57}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 142, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 68, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 55, 'numAffected': 55}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 198, 'numAffected': 198}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 89, 'numAffected': 89}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 58, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 79, 'numAffected': 79}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 206, 'numAffected': 206}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 90, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 61, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 87, 'numAffected': 87}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 135, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 57, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 44, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 57, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 159, 'numAffected': 159}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 71, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 58, 'numAffected': 58}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 114, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 48, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 51, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '3.05', 'groupDescription': 'Demonstration of non-inferiority of a fourth dose of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus a fourth dose of the Tritanrix-HepB/Hiberix and Meningitec vaccine given concomitantly in terms of the percentage of subjects with an SBA-MenC titre ≥ 1:128.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) on the difference in the percentage of subjects with SBA-MenC titre ≥ 1:128 between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the TRITANRIX-HEPB+Mencevax + Meningitec control group was above -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'One month Post-Booster vaccination at 15-24 months of age', 'description': 'Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group versus TRITANRIX-HEPB+Mencevax + Meningitec Group.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'rSBA-MenA (L11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'rSBA-MenA (L10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One Month Post-Booster vaccination at 15-24 months of age', 'description': 'Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group only.'}, {'type': 'PRIMARY', 'title': 'Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in seroprotection rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '3.05', 'groupDescription': 'Demonstration of non-inferiority of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus the Tritanrix-HepB/Hiberix vaccine when used as a booster vaccine in Tritanrix-HepB/Hib-MenAC-TT primed subjects in terms of the percentage of subjects with an anti-PRP concentration ≥ 1.0 µg/mL.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% CI on the difference in seroprotection (anti-PRP concentration ≥ 1.0 µg/mL) between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix Group was above -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'One Month Post-Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT versus Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '122', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-PRP ≥ 0.15 µg/mL (Pre-Booster)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.2', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '99.2', 'groupId': 'OG004'}]}]}, {'title': 'Anti-PRP ≥ 0.15 µg/mL (Post-Booster)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}]}, {'title': 'Anti-PRP ≥ 1 µg/mL (Pre-Booster)', 'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '86.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '87.8', 'groupId': 'OG003'}, {'value': '89.3', 'groupId': 'OG004'}]}]}, {'title': 'Anti-PRP ≥ 1 µg/mL (Post-Booster)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Anti-PRP Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '122', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-PRP (Pre-Booster)', 'categories': [{'measurements': [{'value': '4.572', 'groupId': 'OG000', 'lowerLimit': '3.859', 'upperLimit': '5.416'}, {'value': '4.371', 'groupId': 'OG001', 'lowerLimit': '3.411', 'upperLimit': '5.602'}, {'value': '3.728', 'groupId': 'OG002', 'lowerLimit': '2.872', 'upperLimit': '4.840'}, {'value': '4.498', 'groupId': 'OG003', 'lowerLimit': '3.144', 'upperLimit': '6.436'}, {'value': '4.775', 'groupId': 'OG004', 'lowerLimit': '3.774', 'upperLimit': '6.041'}]}]}, {'title': 'Anti-PRP (Post-Booster)', 'categories': [{'measurements': [{'value': '85.798', 'groupId': 'OG000', 'lowerLimit': '75.274', 'upperLimit': '97.793'}, {'value': '168.232', 'groupId': 'OG001', 'lowerLimit': '140.939', 'upperLimit': '200.812'}, {'value': '56.772', 'groupId': 'OG002', 'lowerLimit': '44.788', 'upperLimit': '71.962'}, {'value': '129.222', 'groupId': 'OG003', 'lowerLimit': '95.254', 'upperLimit': '175.301'}, {'value': '115.384', 'groupId': 'OG004', 'lowerLimit': '95.550', 'upperLimit': '139.336'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-SBA-MENC ≥ 1:8 (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '90.8', 'groupId': 'OG002'}]}]}, {'title': 'Anti-SBA-MENC ≥ 1:8 (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Anti-SBA-MENC ≥ 1:128 (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '61.3', 'groupId': 'OG002'}]}]}, {'title': 'Anti-SBA-MENC ≥1:128 (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.'}, {'type': 'SECONDARY', 'title': 'Anti-SBA-MenC Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-SBA-MenC (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '295.2', 'groupId': 'OG000', 'lowerLimit': '245.7', 'upperLimit': '354.6'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '8.7'}, {'value': '143.8', 'groupId': 'OG002', 'lowerLimit': '105.3', 'upperLimit': '196.4'}]}]}, {'title': 'Anti-SBA-MenC (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4891.2', 'groupId': 'OG000', 'lowerLimit': '4466.0', 'upperLimit': '5356.9'}, {'value': '1868.4', 'groupId': 'OG001', 'lowerLimit': '1495.0', 'upperLimit': '2335.0'}, {'value': '8068.6', 'groupId': 'OG002', 'lowerLimit': '6717.7', 'upperLimit': '9691.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}], 'classes': [{'title': 'rSBA-MenA (L11) ≥ 1:8 Pre-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}, {'value': '88.6', 'groupId': 'OG001'}, {'value': '94.1', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenA (L11) ≥ 1:8 Post-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97.4', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenA (L11) ≥ 1:128 Pre-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}, {'value': '94.1', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenA (L11) ≥1:128 Post-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97.4', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenA (L10) ≥ 1:8 Pre-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000'}, {'value': '54.2', 'groupId': 'OG001'}, {'value': '57.6', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenA (L10) ≥ 1:8 Post-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '90.0', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenA (L10) ≥ 1:128 Pre-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000'}, {'value': '42.4', 'groupId': 'OG001'}, {'value': '42.4', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenA (L10) ≥ 1:128 Post-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.'}, {'type': 'SECONDARY', 'title': 'Anti-rSBA-MenA Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}], 'classes': [{'title': 'rSBA-MenA (L11), Pre-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '626.2', 'groupId': 'OG000', 'lowerLimit': '551.6', 'upperLimit': '711.0'}, {'value': '327.2', 'groupId': 'OG001', 'lowerLimit': '215.4', 'upperLimit': '497.0'}, {'value': '468.3', 'groupId': 'OG002', 'lowerLimit': '290.3', 'upperLimit': '755.4'}]}]}, {'title': 'rSBA-MenA (L11), Post-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1488.8', 'groupId': 'OG000', 'lowerLimit': '1318.7', 'upperLimit': '1680.8'}, {'value': '3429.6', 'groupId': 'OG001', 'lowerLimit': '2939.5', 'upperLimit': '4001.4'}, {'value': '411.5', 'groupId': 'OG002', 'lowerLimit': '297.0', 'upperLimit': '570.0'}]}]}, {'title': 'rSBA-MenA (L10), Pre-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '141.1', 'groupId': 'OG000', 'lowerLimit': '115.1', 'upperLimit': '172.9'}, {'value': '37.1', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '64.7'}, {'value': '33.8', 'groupId': 'OG002', 'lowerLimit': '17.1', 'upperLimit': '67.0'}]}]}, {'title': 'rSBA-MenA (L10), Post-Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1784.8', 'groupId': 'OG000', 'lowerLimit': '1611.2', 'upperLimit': '1977.1'}, {'value': '1663.7', 'groupId': 'OG001', 'lowerLimit': '1415.4', 'upperLimit': '1955.6'}, {'value': '172.5', 'groupId': 'OG002', 'lowerLimit': '100.4', 'upperLimit': '296.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-PSC ≥ 0.3 µg/mL (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}, {'value': '97.5', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSC ≥ 0.3 µg/mL (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSC ≥ 2 µg/mL (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '30.3', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSC ≥ 2 µg/mL (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.'}, {'type': 'SECONDARY', 'title': 'Anti-PSC Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-PSC (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '1.53'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.18'}, {'value': '1.41', 'groupId': 'OG002', 'lowerLimit': '1.23', 'upperLimit': '1.62'}]}]}, {'title': 'Anti-PSC (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.71', 'groupId': 'OG000', 'lowerLimit': '10.82', 'upperLimit': '12.68'}, {'value': '25.96', 'groupId': 'OG001', 'lowerLimit': '22.73', 'upperLimit': '29.65'}, {'value': '31.42', 'groupId': 'OG002', 'lowerLimit': '27.29', 'upperLimit': '36.17'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).', 'unitOfMeasure': 'µg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}], 'classes': [{'title': 'Anti-PSA ≥ 0.3 µg/ml (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSA ≥ 0.3 µg/ml (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSA ≥ 2 µg/ml (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSA ≥ 2 µg/ml (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.'}, {'type': 'SECONDARY', 'title': 'Anti-PSA Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}], 'classes': [{'title': 'Anti-PSA (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.72'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.23'}, {'value': '0.17', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.20'}]}]}, {'title': 'Anti-PSA (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.31', 'groupId': 'OG000', 'lowerLimit': '17.92', 'upperLimit': '23.01'}, {'value': '14.20', 'groupId': 'OG001', 'lowerLimit': '11.95', 'upperLimit': '16.88'}, {'value': '0.19', 'groupId': 'OG002', 'lowerLimit': '0.16', 'upperLimit': '0.23'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().', 'unitOfMeasure': 'µg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.'}, {'type': 'SECONDARY', 'title': 'Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were \\< 0.1 IU/ml when assessed by ELISA.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-D Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-D (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.126', 'groupId': 'OG000', 'lowerLimit': '0.105', 'upperLimit': '0.150'}, {'value': '0.137', 'groupId': 'OG001', 'lowerLimit': '0.116', 'upperLimit': '0.162'}, {'value': '0.134', 'groupId': 'OG002', 'lowerLimit': '0.108', 'upperLimit': '0.166'}, {'value': '0.124', 'groupId': 'OG003', 'lowerLimit': '0.091', 'upperLimit': '0.169'}, {'value': '0.168', 'groupId': 'OG004', 'lowerLimit': '0.143', 'upperLimit': '0.198'}]}]}, {'title': 'Anti-D (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.705', 'groupId': 'OG000', 'lowerLimit': '3.714', 'upperLimit': '5.962'}, {'value': '5.003', 'groupId': 'OG001', 'lowerLimit': '3.958', 'upperLimit': '6.324'}, {'value': '5.297', 'groupId': 'OG002', 'lowerLimit': '3.968', 'upperLimit': '7.070'}, {'value': '5.777', 'groupId': 'OG003', 'lowerLimit': '3.625', 'upperLimit': '9.205'}, {'value': '9.269', 'groupId': 'OG004', 'lowerLimit': '7.812', 'upperLimit': '10.997'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination'}, {'type': 'SECONDARY', 'title': 'Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-TT (Pre-Booster)', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}, {'value': '99.2', 'groupId': 'OG001'}, {'value': '97.4', 'groupId': 'OG002'}, {'value': '97.6', 'groupId': 'OG003'}, {'value': '96.6', 'groupId': 'OG004'}]}]}, {'title': 'Anti-TT (Post-Booster)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination'}, {'type': 'SECONDARY', 'title': 'Anti-TT Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-TT (Pre-Booster)', 'categories': [{'measurements': [{'value': '0.709', 'groupId': 'OG000', 'lowerLimit': '0.622', 'upperLimit': '0.809'}, {'value': '0.648', 'groupId': 'OG001', 'lowerLimit': '0.570', 'upperLimit': '0.737'}, {'value': '0.617', 'groupId': 'OG002', 'lowerLimit': '0.519', 'upperLimit': '0.735'}, {'value': '0.537', 'groupId': 'OG003', 'lowerLimit': '0.427', 'upperLimit': '0.675'}, {'value': '0.566', 'groupId': 'OG004', 'lowerLimit': '0.489', 'upperLimit': '0.655'}]}]}, {'title': 'Anti-TT (Post-Booster)', 'categories': [{'measurements': [{'value': '16.313', 'groupId': 'OG000', 'lowerLimit': '15.089', 'upperLimit': '17.636'}, {'value': '18.942', 'groupId': 'OG001', 'lowerLimit': '17.203', 'upperLimit': '20.857'}, {'value': '12.531', 'groupId': 'OG002', 'lowerLimit': '10.902', 'upperLimit': '14.405'}, {'value': '13.125', 'groupId': 'OG003', 'lowerLimit': '11.071', 'upperLimit': '15.560'}, {'value': '10.792', 'groupId': 'OG004', 'lowerLimit': '9.618', 'upperLimit': '12.108'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination'}, {'type': 'SECONDARY', 'title': 'Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '97.4', 'groupId': 'OG003'}, {'value': '99.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month Post-Booster vaccination', 'description': 'Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination'}, {'type': 'SECONDARY', 'title': 'Anti-BPT Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-BPT (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '13.3'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '11.7'}, {'value': '10.6', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': '12.3'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '8.8', 'upperLimit': '12.6'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '9.9', 'upperLimit': '12.4'}]}]}, {'title': 'Anti-BPT (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '122.1', 'groupId': 'OG000', 'lowerLimit': '109.8', 'upperLimit': '135.8'}, {'value': '115.9', 'groupId': 'OG001', 'lowerLimit': '105.1', 'upperLimit': '127.9'}, {'value': '129.1', 'groupId': 'OG002', 'lowerLimit': '114.0', 'upperLimit': '146.2'}, {'value': '112.6', 'groupId': 'OG003', 'lowerLimit': '90.0', 'upperLimit': '140.8'}, {'value': '102.5', 'groupId': 'OG004', 'lowerLimit': '92.4', 'upperLimit': '113.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).', 'unitOfMeasure': 'EL.U/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination'}, {'type': 'SECONDARY', 'title': 'Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-HBs (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000'}, {'value': '90.8', 'groupId': 'OG001'}, {'value': '94.7', 'groupId': 'OG002'}, {'value': '90.2', 'groupId': 'OG003'}, {'value': '81.6', 'groupId': 'OG004'}]}]}, {'title': 'Anti-HBs (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000'}, {'value': '97.5', 'groupId': 'OG001'}, {'value': '98.7', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '96.6', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination'}, {'type': 'SECONDARY', 'title': 'Anti-HBs Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Anti-HBs (Pre-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000', 'lowerLimit': '41.3', 'upperLimit': '72.8'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '71.8', 'upperLimit': '115.7'}, {'value': '95.0', 'groupId': 'OG002', 'lowerLimit': '71.1', 'upperLimit': '126.8'}, {'value': '84.4', 'groupId': 'OG003', 'lowerLimit': '55.3', 'upperLimit': '129.0'}, {'value': '65.6', 'groupId': 'OG004', 'lowerLimit': '48.9', 'upperLimit': '88.2'}]}]}, {'title': 'Anti-HBs (Post-Booster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3451.8', 'groupId': 'OG000', 'lowerLimit': '2327.5', 'upperLimit': '5119.4'}, {'value': '7801.4', 'groupId': 'OG001', 'lowerLimit': '5724.2', 'upperLimit': '10632.4'}, {'value': '6547.7', 'groupId': 'OG002', 'lowerLimit': '4589.9', 'upperLimit': '9340.5'}, {'value': '7265.8', 'groupId': 'OG003', 'lowerLimit': '5028.1', 'upperLimit': '10499.3'}, {'value': '3334.0', 'groupId': 'OG004', 'lowerLimit': '2310.7', 'upperLimit': '4810.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Day 0 to Day 3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Drowsiness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Related Drowsiness', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Related Irritability', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Loss of appetite', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Related Loss of appetite', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Fever', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Related Fever', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever \\[defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '125', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day (Days 0-30) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '125', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'OG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'OG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'OG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to one month Post-Booster vaccination', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'FG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'FG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'FG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'FG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}, {'value': '617', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'BG001', 'title': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'BG002', 'title': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm'}, {'id': 'BG003', 'title': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.'}, {'id': 'BG004', 'title': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.90', 'spread': '0.52', 'groupId': 'BG000'}, {'value': '17.8', 'spread': '0.59', 'groupId': 'BG001'}, {'value': '17.7', 'spread': '0.59', 'groupId': 'BG002'}, {'value': '17.7', 'spread': '0.67', 'groupId': 'BG003'}, {'value': '17.8', 'spread': '0.55', 'groupId': 'BG004'}, {'value': '17.82', 'spread': '0.56', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '302', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '315', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'East - South East Asian', 'categories': [{'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}, {'value': '617', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Information about race distribution was not available in the report; it was obtained from the primary study.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 617}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2006-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2005-08-26', 'resultsFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-05', 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value', 'timeFrame': 'One month Post-Booster vaccination at 15-24 months of age', 'description': 'Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.'}, {'measure': 'Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value', 'timeFrame': 'One Month Post-Booster vaccination at 15-24 months of age', 'description': 'Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).'}, {'measure': 'Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value', 'timeFrame': 'One Month Post-Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).'}], 'secondaryOutcomes': [{'measure': 'Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).'}, {'measure': 'Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.'}, {'measure': 'Anti-SBA-MenC Antibody Titers', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).'}, {'measure': 'Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).'}, {'measure': 'Anti-rSBA-MenA Antibody Titers', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).'}, {'measure': 'Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).'}, {'measure': 'Anti-PSC Antibody Concentrations', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).'}, {'measure': 'Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).'}, {'measure': 'Anti-PSA Antibody Concentrations', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().'}, {'measure': 'Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values', 'timeFrame': 'One month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were \\< 0.1 IU/ml when assessed by ELISA.'}, {'measure': 'Anti-D Antibody Concentrations', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).'}, {'measure': 'Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).'}, {'measure': 'Anti-TT Antibody Concentrations', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).'}, {'measure': 'Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value', 'timeFrame': 'One month Post-Booster vaccination', 'description': 'Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).'}, {'measure': 'Anti-BPT Antibody Concentrations', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).'}, {'measure': 'Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).'}, {'measure': 'Anti-HBs Antibody Concentrations', 'timeFrame': 'Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age', 'description': 'Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Day 0 to Day 3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever \\[defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 31-day (Days 0-30) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to one month Post-Booster vaccination', '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': ['Prophylaxis diphtheria', 'Hib & meningococcal serogroup A & C disease'], 'conditions': ['Whole Cell Pertussis', 'Haemophilus Influenzae Type b', 'Hepatitis B', 'Diphtheria', 'Tetanus', 'Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin']}, 'referencesModule': {'availIpds': [{'id': '104727 (Booster - 15-24 mths)', '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': '104727 (Booster - 15-24 mths)', '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': '104727 (Booster - 15-24 mths)', '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': '104727 (Booster - 15-24 mths)', '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': '104727 (Booster - 15-24 mths)', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104727 (Booster - 15-24 mths)', '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': 'http://www.clinicaltrials.gov/ct/show/NCT00317161', 'label': 'Primary Study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.', 'detailedDescription': "This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '730 Days', 'minimumAge': '427 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy male or female between and including 15 and 24 months of age\n* Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)\n\nExclusion criteria:\n\n* Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).\n* History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition.\n* A family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or serious chronic illness.\n* History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.'}, 'identificationModule': {'nctId': 'NCT00136604', 'briefTitle': "Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals' Tritanrix-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix-HepB/Hib-MenAC", 'orgStudyIdInfo': {'id': '104727 (Booster - 15-24 mths)'}, 'secondaryIdInfos': [{'id': '104730'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACAC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.', 'interventionNames': ['Biological: Tritanrix-HepB/Hib-MenAC']}, {'type': 'EXPERIMENTAL', 'label': 'ACHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm', 'interventionNames': ['Biological: Mencevax ACWY', 'Biological: Tritanrix-HepB/Hiberix']}, {'type': 'EXPERIMENTAL', 'label': 'HibACPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm', 'interventionNames': ['Biological: Tritanrix-HepB/Hib-MenAC', 'Biological: Mencevax ACWY']}, {'type': 'EXPERIMENTAL', 'label': 'HibHibPS GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.', 'interventionNames': ['Biological: Mencevax ACWY', 'Biological: Tritanrix-HepB/Hiberix']}, {'type': 'EXPERIMENTAL', 'label': 'CC GROUP', 'description': 'Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.', 'interventionNames': ['Biological: Tritanrix-HepB/Hiberix', 'Biological: Meningitec']}], 'interventions': [{'name': 'Tritanrix-HepB/Hib-MenAC', 'type': 'BIOLOGICAL', 'description': 'Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine', 'armGroupLabels': ['ACAC GROUP', 'HibACPS GROUP']}, {'name': 'Mencevax ACWY', 'type': 'BIOLOGICAL', 'description': "GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine", 'armGroupLabels': ['ACHibPS GROUP', 'HibACPS GROUP', 'HibHibPS GROUP']}, {'name': 'Tritanrix-HepB/Hiberix', 'type': 'BIOLOGICAL', 'description': 'Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine', 'armGroupLabels': ['ACHibPS GROUP', 'CC GROUP', 'HibHibPS GROUP']}, {'name': 'Meningitec', 'type': 'BIOLOGICAL', 'description': "Wyeth's MenC CRM197 conjugated vaccine, Meningitec", 'armGroupLabels': ['CC GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '90110', 'city': 'Songkhla', 'country': 'Thailand', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}], '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'}}}}