Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:19 AM
Study NCT ID:
NCT01449812
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2011-10-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}, {'id': 'D004369', 'term': 'Pentetic Acid'}], 'ancestors': [{'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, '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 and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).', 'eventGroups': [{'id': 'EG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.', 'otherNumAtRisk': 272, 'deathsNumAtRisk': 272, 'otherNumAffected': 157, 'seriousNumAtRisk': 272, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 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'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'notes': 'This solicited local symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 279, 'numAffected': 76}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Redness', 'notes': 'This solicited local symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 279, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Swelling', 'notes': 'This solicited local symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 279, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Drowsiness', 'notes': 'This solicited general symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 279, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Irritability', 'notes': 'This solicited general symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 279, 'numAffected': 72}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Loss of appetite', 'notes': 'This solicited general symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 279, 'numAffected': 69}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fever', 'notes': 'This solicited general symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 105}, {'groupId': 'EG002', 'numAtRisk': 279, 'numAffected': 91}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}]}, {'title': 'Anti-T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.'}, {'type': 'PRIMARY', 'title': 'Anti-D and Anti-T Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.175', 'groupId': 'OG000', 'lowerLimit': '0.163', 'upperLimit': '0.188'}, {'value': '0.189', 'groupId': 'OG001', 'lowerLimit': '0.176', 'upperLimit': '0.202'}, {'value': '0.154', 'groupId': 'OG002', 'lowerLimit': '0.142', 'upperLimit': '0.166'}]}]}, {'title': 'Anti-T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.423', 'upperLimit': '0.478'}, {'value': '0.509', 'groupId': 'OG001', 'lowerLimit': '0.481', 'upperLimit': '0.54'}, {'value': '0.38', 'groupId': 'OG002', 'lowerLimit': '0.359', 'upperLimit': '0.404'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.'}, {'type': 'PRIMARY', 'title': 'Anti-PRP Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.275', 'groupId': 'OG000', 'lowerLimit': '1.856', 'upperLimit': '2.788'}, {'value': '2.674', 'groupId': 'OG001', 'lowerLimit': '2.193', 'upperLimit': '3.26'}, {'value': '2.413', 'groupId': 'OG002', 'lowerLimit': '2.006', 'upperLimit': '2.904'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Polio Type 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-polio 1', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}]}, {'title': 'Anti-polio 2', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}]}, {'title': 'Anti-polio 3', 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.'}, {'type': 'PRIMARY', 'title': 'Anti-polio Type 1, 2 and 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-polio 1', 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '83.7'}, {'value': '95.7', 'groupId': 'OG001', 'lowerLimit': '82.5', 'upperLimit': '111'}, {'value': '77.2', 'groupId': 'OG002', 'lowerLimit': '67', 'upperLimit': '89'}]}]}, {'title': 'Anti-polio 2', 'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '70'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '53.5', 'upperLimit': '75.5'}, {'value': '42.6', 'groupId': 'OG002', 'lowerLimit': '35.7', 'upperLimit': '50.8'}]}]}, {'title': 'Anti-polio 3', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000', 'lowerLimit': '60.1', 'upperLimit': '84.7'}, {'value': '79.9', 'groupId': 'OG001', 'lowerLimit': '66.4', 'upperLimit': '96.2'}, {'value': '60.6', 'groupId': 'OG002', 'lowerLimit': '51.2', 'upperLimit': '71.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.'}, {'type': 'PRIMARY', 'title': 'Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.'}, {'type': 'PRIMARY', 'title': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '11.1'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '13.1'}, {'value': '10.4', 'groupId': 'OG002', 'lowerLimit': '9.6', 'upperLimit': '11.2'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '11.9', 'upperLimit': '13.7'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '15.2'}, {'value': '12.4', 'groupId': 'OG002', 'lowerLimit': '11.5', 'upperLimit': '13.4'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '9.7'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '10.1'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '8.5', 'upperLimit': '9.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}]}, {'title': 'Anti-T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}]}, {'title': 'Anti-T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Anti-D and Anti-T Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.174', 'groupId': 'OG000', 'lowerLimit': '0.162', 'upperLimit': '0.187'}, {'value': '0.189', 'groupId': 'OG001', 'lowerLimit': '0.176', 'upperLimit': '0.202'}, {'value': '0.154', 'groupId': 'OG002', 'lowerLimit': '0.142', 'upperLimit': '0.166'}]}]}, {'title': 'Anti-T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.455', 'groupId': 'OG000', 'lowerLimit': '0.429', 'upperLimit': '0.483'}, {'value': '0.511', 'groupId': 'OG001', 'lowerLimit': '0.482', 'upperLimit': '0.542'}, {'value': '0.38', 'groupId': 'OG002', 'lowerLimit': '0.357', 'upperLimit': '0.403'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Anti-D and Anti-T Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.341', 'groupId': 'OG000', 'lowerLimit': '1.239', 'upperLimit': '1.451'}, {'value': '1.504', 'groupId': 'OG001', 'lowerLimit': '1.377', 'upperLimit': '1.643'}, {'value': '1.227', 'groupId': 'OG002', 'lowerLimit': '1.134', 'upperLimit': '1.326'}]}]}, {'title': 'Anti-T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.862', 'groupId': 'OG000', 'lowerLimit': '4.614', 'upperLimit': '5.124'}, {'value': '4.927', 'groupId': 'OG001', 'lowerLimit': '4.693', 'upperLimit': '5.173'}, {'value': '4.371', 'groupId': 'OG002', 'lowerLimit': '4.161', 'upperLimit': '4.591'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against PRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Anti-PRP Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.308', 'groupId': 'OG000', 'lowerLimit': '1.878', 'upperLimit': '2.836'}, {'value': '2.743', 'groupId': 'OG001', 'lowerLimit': '2.245', 'upperLimit': '3.352'}, {'value': '2.407', 'groupId': 'OG002', 'lowerLimit': '1.993', 'upperLimit': '2.908'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Anti-PRP Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.178', 'groupId': 'OG000', 'lowerLimit': '30.617', 'upperLimit': '40.418'}, {'value': '49.023', 'groupId': 'OG001', 'lowerLimit': '43.649', 'upperLimit': '55.058'}, {'value': '27.682', 'groupId': 'OG002', 'lowerLimit': '24.251', 'upperLimit': '31.598'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-Polio 1', 'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}]}, {'title': 'Anti-Polio 2', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}]}, {'title': 'Anti-Polio 3', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster 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ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Anti-polio Type 1, 2 and 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age 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DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-Polio 1', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '83.7'}, {'value': '96.3', 'groupId': 'OG001', 'lowerLimit': '82.8', 'upperLimit': '112'}, {'value': '75.9', 'groupId': 'OG002', 'lowerLimit': '65.7', 'upperLimit': '87.6'}]}]}, {'title': 'Anti-Polio 2', 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '46.2', 'upperLimit': '69'}, {'value': '64.1', 'groupId': 'OG001', 'lowerLimit': '53.8', 'upperLimit': '76.4'}, {'value': '41.9', 'groupId': 'OG002', 'lowerLimit': '35', 'upperLimit': '50'}]}]}, {'title': 'Anti-Polio 3', 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000', 'lowerLimit': '61.1', 'upperLimit': '86.3'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '65.8', 'upperLimit': '95.8'}, {'value': '60.3', 'groupId': 'OG002', 'lowerLimit': '50.8', 'upperLimit': '71.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Anti-polio Type 1, 2 and 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-Polio 1', 'categories': [{'measurements': [{'value': '3512.2', 'groupId': 'OG000', 'lowerLimit': '3159.7', 'upperLimit': '3904.1'}, {'value': '3410.9', 'groupId': 'OG001', 'lowerLimit': '3081.7', 'upperLimit': '3775.4'}, {'value': '3386.8', 'groupId': 'OG002', 'lowerLimit': '3078', 'upperLimit': '3726.6'}]}]}, {'title': 'Anti-Polio 2', 'categories': [{'measurements': [{'value': '1931.2', 'groupId': 'OG000', 'lowerLimit': '1721.7', 'upperLimit': '2166.2'}, {'value': '2237.9', 'groupId': 'OG001', 'lowerLimit': '2001.6', 'upperLimit': '2502.1'}, {'value': '1886.1', 'groupId': 'OG002', 'lowerLimit': '1679.6', 'upperLimit': '2117.9'}]}]}, {'title': 'Anti-Polio 3', 'categories': [{'measurements': [{'value': '5237.8', 'groupId': 'OG000', 'lowerLimit': '4671.8', 'upperLimit': '5872.3'}, {'value': '5438.5', 'groupId': 'OG001', 'lowerLimit': '4846.8', 'upperLimit': '6102.4'}, {'value': '5141.2', 'groupId': 'OG002', 'lowerLimit': '4650.1', 'upperLimit': '5684.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '255', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '11.1'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '13.1'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '11.2'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '13.6'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '15.2'}, {'value': '12.3', 'groupId': 'OG002', 'lowerLimit': '11.4', 'upperLimit': '13.3'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '9.6'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '10.2'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '8.5', 'upperLimit': '9.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '138.5', 'groupId': 'OG000', 'lowerLimit': '132', 'upperLimit': '145.3'}, {'value': '146.2', 'groupId': 'OG001', 'lowerLimit': '139.7', 'upperLimit': '153'}, {'value': '126.8', 'groupId': 'OG002', 'lowerLimit': '120.4', 'upperLimit': '133.5'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '124.6', 'groupId': 'OG000', 'lowerLimit': '119.2', 'upperLimit': '130.2'}, {'value': '124', 'groupId': 'OG001', 'lowerLimit': '119.2', 'upperLimit': '129'}, {'value': '120.8', 'groupId': 'OG002', 'lowerLimit': '115.3', 'upperLimit': '126.6'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '55.6', 'upperLimit': '59.1'}, {'value': '59.9', 'groupId': 'OG001', 'lowerLimit': '58.1', 'upperLimit': '61.8'}, {'value': '57.2', 'groupId': 'OG002', 'lowerLimit': '55.3', 'upperLimit': '59.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations \\< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}], '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 and fever \\[defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], '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 analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Month 0 up to Month 1)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'FG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '273'}, {'groupId': 'FG002', 'numSubjects': '280'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '273'}, {'groupId': 'FG002', 'numSubjects': '279'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '6 subjects did not receive vaccination.', 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}, {'value': '825', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Infanrix+Hib/Poliorix 1 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'BG001', 'title': 'Infanrix+Hib/Poliorix 2 Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '0.93', 'groupId': 'BG000'}, {'value': '19.4', 'spread': '0.91', 'groupId': 'BG001'}, {'value': '19.5', 'spread': '0.97', 'groupId': 'BG002'}, {'value': '19.47', 'spread': '0.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '377', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '448', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian-Chinese heritage', 'categories': [{'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}, {'value': '825', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 831}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'dispFirstSubmitDate': '2012-07-24', 'completionDateStruct': {'date': '2012-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2011-10-06', 'dispFirstSubmitQcDate': '2012-07-24', 'resultsFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2011-10-06', 'dispFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-12', 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).'}, {'measure': 'Anti-D and Anti-T Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Polio Type 1, 2 and 3', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.'}, {'measure': 'Anti-polio Type 1, 2 and 3 Antibody Titers', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.'}, {'measure': 'Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).'}, {'measure': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.'}, {'measure': 'Anti-D and Anti-T Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.'}, {'measure': 'Anti-D and Anti-T Antibody Concentrations', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.'}, {'measure': 'Number of Seroprotected Subjects Against PRP', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.'}, {'measure': 'Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.'}, {'measure': 'Number of Seroprotected Subjects Against Polio Type 1, 2 and 3', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.'}, {'measure': 'Anti-polio Type 1, 2 and 3 Antibody Titers', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.'}, {'measure': 'Anti-polio Type 1, 2 and 3 Antibody Titers', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.'}, {'measure': 'Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).'}, {'measure': 'Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.'}, {'measure': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Day 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.'}, {'measure': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.'}, {'measure': 'Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations \\< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Any Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.'}, {'measure': 'Number of Subjects With Any Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \\[defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade and relationship to 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': 'During the entire study period (from Month 0 up to Month 1)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}]}, 'conditionsModule': {'keywords': ['combination vaccine', 'booster vaccination'], 'conditions': ['Acellular Pertussis', 'Tetanus', 'Diphtheria', 'Haemophilus Influenzae Type b']}, 'descriptionModule': {'briefSummary': "The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.\n\nThis protocol posting deals with objectives \\& outcome measures of the booster phase. The objectives \\& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.\n* Subjects who completed the full three-dose primary vaccination course in study NCT01086423.\n* Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol\n* Written informed consent obtained from the parent(s)/LAR(s) of the subject.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n\nExclusion Criteria:\n\n* Child in care\n* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the study vaccine, or planned use during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.\n* Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period.\n* Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.\n* Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423.\n* Serious chronic illness.\n* Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.\n* Occurrence of any of the following adverse events after a previous administration of a DTP vaccine.\n* Encephalopathy\n* Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.\n* Collapse or shock-like state within 48 hours of vaccination.\n* Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.\n* Seizures with or without fever occurring within 3 days of vaccination.\n\nThe following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:\n\n* Acute disease and/or fever at the time of enrolment.'}, 'identificationModule': {'nctId': 'NCT01449812', 'briefTitle': "Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers", 'orgStudyIdInfo': {'id': '114386'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INFANRIX+HIB/POLIORIX 1 GROUP', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.', 'interventionNames': ['Biological: Infanrix+Hib™', 'Biological: Poliorix™']}, {'type': 'EXPERIMENTAL', 'label': 'INFANRIX+HIB/POLIORIX 2 GROUP', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.', 'interventionNames': ['Biological: Infanrix+Hib™', 'Biological: Poliorix™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL GROUP', 'description': 'Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.', 'interventionNames': ['Biological: Infanrix+Hib™', 'Biological: Poliorix™']}], 'interventions': [{'name': 'Infanrix+Hib™', 'type': 'BIOLOGICAL', 'otherNames': ['DTPa /Hib'], 'description': 'Intramuscular, one dose', 'armGroupLabels': ['CONTROL GROUP', 'INFANRIX+HIB/POLIORIX 1 GROUP', 'INFANRIX+HIB/POLIORIX 2 GROUP']}, {'name': 'Poliorix™', 'type': 'BIOLOGICAL', 'otherNames': ['IPV'], 'description': 'Intramuscular, one dose', 'armGroupLabels': ['CONTROL GROUP', 'INFANRIX+HIB/POLIORIX 1 GROUP', 'INFANRIX+HIB/POLIORIX 2 GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '543002', 'city': 'Wuzhou', 'state': 'Guangxi', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.48054, 'lon': 111.28848}}, {'zip': '543100', 'city': 'Wuzhou', 'state': 'Guangxi', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.48054, 'lon': 111.28848}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}