Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT00586612
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2007-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}], 'ancestors': [{'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}]}}, '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': 'For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination.', 'description': 'Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.', 'eventGroups': [{'id': 'EG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.', 'otherNumAtRisk': 163, 'otherNumAffected': 153, 'seriousNumAtRisk': 163, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.', 'otherNumAtRisk': 150, 'otherNumAffected': 144, 'seriousNumAtRisk': 150, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'notes': 'Within 4 days after primary vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 100}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Redness', 'notes': 'Within 4 days after primary vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 123}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Swelling', 'notes': 'Within 4 days after primary vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 113}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Drowsiness', 'notes': 'Within 4 days after primary vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fever', 'notes': 'Within 4 days after primary vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 85}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Irritability/fussiness', 'notes': 'Within 4 days after primary vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 105}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Loss of appetite', 'notes': 'Within 4 days after primary vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 100}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'notes': 'Within 4 days after booster dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 98}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Redness', 'notes': 'Within 4 days after booster dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 109}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Swelling', 'notes': 'Within 4-days after booster vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Drowsiness', 'notes': 'Within 4 days after booster vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fever', 'notes': 'Within 4 days after booster vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Irritability/fussiness', 'notes': 'Within 4 days after booster vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 69}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Loss of appetite', 'notes': 'Within 4 days after booster vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Meningococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the third vaccination', 'description': 'Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available data.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the third vaccination', 'description': 'rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 0.15 µg/mL', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': '≥ 1.0 µg/mL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the third vaccination', 'description': 'Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 1:8', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '≥ 1:32', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '≥ 1:128', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 1:32', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': '≥ 1:128', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the third vaccination', 'description': 'rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 0.3 µg/mL', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': '≥ 2.0 µg/mL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 0.3 µg/mL', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}, {'title': '≥ 2.0 µg/mL', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the third dose', 'description': 'Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 10 mIU/mL', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': '≥ 100 mIU/mL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 10 mIU/mL', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': '≥ 100 mIU/mL', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the third dose', 'description': 'Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PRP (n=140, 138)', 'categories': [{'measurements': [{'value': '0.116', 'groupId': 'OG000', 'lowerLimit': '0.101', 'upperLimit': '0.133'}, {'value': '0.140', 'groupId': 'OG001', 'lowerLimit': '0.117', 'upperLimit': '0.167'}]}]}, {'title': 'Anti-PSC (n=142, 137)', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.22'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '0.30'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'micrograms per milliliter (µg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PRP (n= 140, 142)', 'categories': [{'measurements': [{'value': '10.437', 'groupId': 'OG000', 'lowerLimit': '8.398', 'upperLimit': '12.970'}, {'value': '10.473', 'groupId': 'OG001', 'lowerLimit': '8.547', 'upperLimit': '12.833'}]}]}, {'title': 'Anti-PSC (n= 140, 141)', 'categories': [{'measurements': [{'value': '6.34', 'groupId': 'OG000', 'lowerLimit': '5.57', 'upperLimit': '7.22'}, {'value': '7.46', 'groupId': 'OG001', 'lowerLimit': '6.67', 'upperLimit': '8.34'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the third dose', 'description': 'Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'micrograms per milliliter (µg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.79', 'groupId': 'OG000', 'lowerLimit': '19.82', 'upperLimit': '31.00'}, {'value': '16.67', 'groupId': 'OG001', 'lowerLimit': '13.52', 'upperLimit': '20.56'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '372.30', 'groupId': 'OG000', 'lowerLimit': '299.98', 'upperLimit': '462.04'}, {'value': '586.58', 'groupId': 'OG001', 'lowerLimit': '473.80', 'upperLimit': '726.21'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the third dose', 'description': 'Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '5.5'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '6.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'rSBA-MenC titers are given as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '1055.9', 'groupId': 'OG000', 'lowerLimit': '859.1', 'upperLimit': '1297.7'}, {'value': '1346.2', 'groupId': 'OG001', 'lowerLimit': '1130.4', 'upperLimit': '1603.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the third dose', 'description': 'rSBA-MenC titers are given as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day follow-up period after any primary vaccination dose', 'description': 'Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary Total Vaccinated Cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'Drowsiness', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Irritability/fussiness', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day follow-up period after any primary vaccination dose', 'description': 'Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary Total Vaccinated Cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 31 days after each primary vaccination', 'description': 'Unsolicited AE covers any AE 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.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary Total Vaccinated Cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the entire primary vaccination phase', 'description': 'SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Primary Total Vaccinated Cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'Pre-booster (n= 133; 130)', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Post-booster (n= 132; 134)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'Pre-booster (n= 133; 130)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Post-booster (n= 132; 134)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 1:8 pre-booster (n= 134; 134)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': '≥ 1:8 post-booster (n= 133; 137)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': '≥ 1:32 pre-booster (n= 134; 134)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': '≥ 1:32 post-booster (n= 133; 137)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': '≥ 1:128 pre-booster (n= 134; 134)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': '≥ 1:128 post-booster (n= 133; 137)', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 0.3 µg/mL pre-booster (n= 130; 127)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': '≥ 0.3 µg/mL post-booster (n= 117; 129)', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': '≥ 2.0 µg/mL pre-booster (n= 130; 127)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '≥ 2.0 µg/mL post-booster (n= 117; 129)', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': '≥ 10 mIU/mL pre-booster', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': '≥ 100 mIU/mL pre-booster', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Month 14) the booster vaccination', 'description': 'Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.\n\nNote: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.'}, {'type': 'SECONDARY', 'title': 'Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'anti-PRP pre-booster (n= 133; 130)', 'categories': [{'measurements': [{'value': '0.706', 'groupId': 'OG000', 'lowerLimit': '0.565', 'upperLimit': '0.881'}, {'value': '0.777', 'groupId': 'OG001', 'lowerLimit': '0.622', 'upperLimit': '0.972'}]}]}, {'title': 'anti-PRP post-booster (n= 132; 134)', 'categories': [{'measurements': [{'value': '50.343', 'groupId': 'OG000', 'lowerLimit': '41.627', 'upperLimit': '60.884'}, {'value': '54.625', 'groupId': 'OG001', 'lowerLimit': '45.325', 'upperLimit': '65.834'}]}]}, {'title': 'anti-PSC pre-booster (n= 130; 127)', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.51'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.47', 'upperLimit': '0.67'}]}]}, {'title': 'anti-PSC post-booster (n= 117; 129)', 'categories': [{'measurements': [{'value': '10.06', 'groupId': 'OG000', 'lowerLimit': '8.14', 'upperLimit': '12.45'}, {'value': '11.31', 'groupId': 'OG001', 'lowerLimit': '9.60', 'upperLimit': '13.31'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'micrograms per milliliter (µg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.'}, {'type': 'SECONDARY', 'title': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '75.6', 'upperLimit': '121.5'}, {'value': '145.6', 'groupId': 'OG001', 'lowerLimit': '112.1', 'upperLimit': '189.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Month 14) the booster vaccination', 'description': 'Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL).\n\nNote: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.'}, {'type': 'SECONDARY', 'title': 'Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'Pre-booster (n= 134; 134)', 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '56.3', 'upperLimit': '111.8'}, {'value': '147.8', 'groupId': 'OG001', 'lowerLimit': '110.9', 'upperLimit': '197.1'}]}]}, {'title': 'Post-booster (n= 133; 137)', 'categories': [{'measurements': [{'value': '4883.1', 'groupId': 'OG000', 'lowerLimit': '3783.1', 'upperLimit': '6302.9'}, {'value': '5288.8', 'groupId': 'OG001', 'lowerLimit': '4244.9', 'upperLimit': '6589.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'rSBA-MenC titers are given as geometric mean titers (GMTs).', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Symptoms (Local and General)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Drowsiness', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day follow-up period following booster vaccination', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 31 days after the booster vaccination (month 15)', 'description': 'Unsolicited AE covers any AE 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.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'classes': [{'title': 'Period 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)', 'description': 'SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.\n\nPeriod 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14).\n\nPeriod 2 is defined as the administration of the booster dose until the end of the study (Month 15).', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'FG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}], 'periods': [{'title': 'Primary Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Booster Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Preterm Group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'BG001', 'title': 'Full-term Group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '1.15', 'groupId': 'BG000'}, {'value': '8.8', 'spread': '0.79', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '0.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 313}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2008-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2007-12-21', 'resultsFirstSubmitDate': '2009-12-17', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-12-17', 'studyFirstPostDateStruct': {'date': '2008-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)', 'timeFrame': 'One month after the third vaccination', 'description': 'Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.'}, {'measure': 'Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8', 'timeFrame': 'One month after the third vaccination', 'description': 'rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.'}, {'measure': 'Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter', 'timeFrame': 'One month after the third vaccination', 'description': 'Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).'}, {'measure': 'Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.'}, {'measure': 'Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values', 'timeFrame': 'One month after the third vaccination', 'description': 'rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.'}, {'measure': 'Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.'}, {'measure': 'Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values', 'timeFrame': 'One month after the third dose', 'description': 'Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.'}, {'measure': 'Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.'}, {'measure': 'Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values', 'timeFrame': 'One month after the third dose', 'description': 'Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.'}, {'measure': 'Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).'}, {'measure': 'Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration', 'timeFrame': 'One month after the third dose', 'description': 'Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).'}, {'measure': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration', 'timeFrame': 'One month after the third dose', 'description': 'Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer', 'timeFrame': 'Before vaccination (at Day 0)', 'description': 'rSBA-MenC titers are given as geometric mean titers (GMTs).'}, {'measure': 'Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer', 'timeFrame': 'One month after the third dose', 'description': 'rSBA-MenC titers are given as geometric mean titers (GMTs).'}, {'measure': 'Number of Subjects Reporting Solicited Local Symptoms', 'timeFrame': 'During the 4-day follow-up period after any primary vaccination dose', 'description': 'Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.'}, {'measure': 'Number of Subjects Reporting Solicited General Symptoms', 'timeFrame': 'During the 4-day follow-up period after any primary vaccination dose', 'description': 'Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 31 days after each primary vaccination', 'description': 'Unsolicited AE covers any AE 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.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs)', 'timeFrame': 'Throughout the entire primary vaccination phase', 'description': 'SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.'}, {'measure': 'Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL)', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).'}, {'measure': 'Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL)', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).'}, {'measure': 'Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.'}, {'measure': 'Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.'}, {'measure': 'Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values', 'timeFrame': 'Prior to (Month 14) the booster vaccination', 'description': 'Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.\n\nNote: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component.'}, {'measure': 'Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).'}, {'measure': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration', 'timeFrame': 'Prior to (Month 14) the booster vaccination', 'description': 'Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL).\n\nNote: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component.'}, {'measure': 'Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer', 'timeFrame': 'Prior to (Month 14) and one month after the booster vaccination (Month 15)', 'description': 'rSBA-MenC titers are given as geometric mean titers (GMTs).'}, {'measure': 'Number of Subjects Reporting Solicited Symptoms (Local and General)', 'timeFrame': 'During the 4-day follow-up period following booster vaccination', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 31 days after the booster vaccination (month 15)', 'description': 'Unsolicited AE covers any AE 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.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs)', 'timeFrame': '31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)', 'description': 'SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.\n\nPeriod 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14).\n\nPeriod 2 is defined as the administration of the booster dose until the end of the study (Month 15).'}]}, 'conditionsModule': {'keywords': ['Conjugate vaccine', 'Persistence', 'Hib vaccine', 'Combination vaccine', 'Meningococcal vaccine', 'Safety', 'Preterm/full-term infants', 'Immunogenicity'], 'conditions': ['Haemophilus Influenzae Type b', 'Neisseria Meningitidis']}, 'referencesModule': {'availIpds': [{'id': '110215', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register. The results of this study are summarised with 110217 on the GSK Clinical Study Register.'}, {'id': '110215', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110215', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110215', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110215', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110215', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110215', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity \\& safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) \\& Wyeth's 7-valent pneumococcal conjugate vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in the second year of life (16-18 months of age). The control is a group of full-term infants receiving the same vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.", 'detailedDescription': 'This multicenter study is open \\& consists of a primary \\& a booster phase. The study has 2 treatment groups (Preterm \\& Full-term) that will receive the same vaccinations; the Full-term group will be the active control. Four blood samples will be collected from all subjects for immunogenicity analyses; 2 in the primary phase at prior to the first vaccination and one month after the third vaccination and 2 in the booster phase at prior to booster dose and one month after booster dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '8 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects must satisfy the following criteria at study entry:\n\n* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.\n* A male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.\n* Written informed consent obtained from the parent or guardian of the subject.\n\nAll preterm subjects must satisfy the following criteria at study entry:\n\n* Born after a gestation period of less than or equal to 36 weeks (≤258 days).\n* Medically stable, i.e. do not require significant medical support or ongoing management for debilitating disease and have demonstrated a clinical course of sustained recovery.\n\nAll full-term subjects must satisfy the following criteria at study entry:\n\n* Born after a gestation period between and including 37 and 42 weeks (≥259 days and ≤294 days).\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine until the last study visit, except measles-mumps-rubella (MMR) and varicella vaccines which may be given according to local immunisation practices and except rotavirus oral vaccine which is allowed at anytime during the study after hospital discharge as per prescribing information.\n* Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C and or Streptococcus pneumoniae disease, with the exception of hepatitis B vaccine or BCG vaccine given in the first month of life according to the national recommendations (although BCG and hepatitis B vaccines should have been given outside a 30-day window from the first administration of study vaccines).\n* History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.\n* A family history of congenital or hereditary immunodeficiency.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).\n* Major congenital defects or serious chronic illness.\n* History of any neurologic disorders or seizures.\n* Acute disease at the time of enrolment.\n* Administration of immunoglobulins (with the exception of monoclonal antibodies against respiratory syncytial virus \\[RSV\\]) and/or any blood products within one month (30 days) preceding the first dose of study vaccines.\n* Planned administration of immunoglobulins and/or any blood products during the active phase of the study.\n\nSpecific criteria for the booster part of the study (to be checked at Visit 5, study month 14):\n\n* History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease.\n* Previous vaccination, except the study vaccines and hepatitis birth dose, against diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease.\n* Previous booster vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and/or S. pneumoniae disease.'}, 'identificationModule': {'nctId': 'NCT00586612', 'briefTitle': 'Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity & Safety Study in Preterm & Full-term Infants of GSK Biologicals' Hib-MenC Vaccine, Menitorix™ Co-administered With Infanrix™ Penta & Prevenar™ at 2, 4, 6 Months & as a Booster With Infanrix™ IPV & Prevenar™ at 16-18 Months", 'orgStudyIdInfo': {'id': '110215'}, 'secondaryIdInfos': [{'id': '110217', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preterm group', 'description': 'Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.', 'interventionNames': ['Biological: Menitorix™', 'Biological: Infanrix™ penta', 'Biological: Prevenar™', 'Biological: Infanrix™ IPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Full-term group', 'description': 'Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.', 'interventionNames': ['Biological: Menitorix™', 'Biological: Infanrix™ penta', 'Biological: Prevenar™', 'Biological: Infanrix™ IPV']}], 'interventions': [{'name': 'Menitorix™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.', 'armGroupLabels': ['Full-term group', 'Preterm group']}, {'name': 'Infanrix™ penta', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 doses in the primary study', 'armGroupLabels': ['Full-term group', 'Preterm group']}, {'name': 'Prevenar™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.', 'armGroupLabels': ['Full-term group', 'Preterm group']}, {'name': 'Infanrix™ IPV', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 1 dose in the Booster study.', 'armGroupLabels': ['Full-term group', 'Preterm group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '09005', 'city': 'Burgos', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '28905', 'city': 'Getafe', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28047', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '28935', 'city': 'Móstoles/Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}