Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-27 @ 4:40 AM
Study NCT ID:
NCT00609492
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2008-01-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, '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}, 'limitationsAndCaveats': {'description': 'None reported.'}}, 'adverseEventsModule': {'timeFrame': 'Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.', 'eventGroups': [{'id': 'EG000', 'title': 'Preterm Group', 'description': 'Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.', 'otherNumAtRisk': 116, 'otherNumAffected': 71, 'seriousNumAtRisk': 116, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.', 'otherNumAtRisk': 129, 'otherNumAffected': 98, 'seriousNumAtRisk': 129, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 67, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 65, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 55, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fever (rectal temperature measurement)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4-days (Day 0-3) after booster vaccination', 'description': 'Fever was measured as rectal temperature. Assessment of occurrences of fever \\> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4-days (Day 0-3) after booster vaccination', 'description': 'Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4-days (Day 0-3) after booster vaccination', 'description': 'Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 31-days (Day 0-30) after booster vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the active phase of the study (Month 0 to Month 1)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Anti-pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-1, Pre-booster [N=43;66;121]', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}]}, {'title': 'Anti-1, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-4, Pre-booster [N=43;69;123]', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}]}, {'title': 'Anti-4, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-5, Pre-booster [N=43;68;124]', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}, {'title': 'Anti-5, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6B, Pre-booster [N=43;67;124]', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6B, Post-booster [N=42;66;119]', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-7F, Pre-booster [N=43;65;123]', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}]}, {'title': 'Anti-7F, Post-booster [N=43;66;118]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Anti-9V, Pre-booster [N=43;69;123]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}]}, {'title': 'Anti-9V, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-14, Pre-booster [N=43;68;124]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}]}, {'title': 'Anti-14, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-18C, Pre-booster [N=43;68;125]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}]}, {'title': 'Anti-18C, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19F, Pre-booster [N=43;68;125]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19F, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-23F, Pre-booster [N=43;69;123]', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}, {'title': 'Anti-23F, Post-booster [N=42;66;119]', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-1, Pre-booster [N=43;66;121]', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Anti-1, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Anti-4, Pre-booster [N=43;69;123]', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}]}, {'title': 'Anti-4, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-5, Pre-booster [N=43;68;124]', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}, {'title': 'Anti-5, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6B, Pre-booster [N=43;67;124]', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6B, Post-booster [N=42;66;119]', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-7F, Pre-booster [N=43;65;123]', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}]}, {'title': 'Anti-7F, Post-booster [N=43;66;118]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Anti-9V, Pre-booster [N=43;69;123]', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}]}, {'title': 'Anti-9V, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-14, Pre-booster [N=43;68;124]', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}, {'title': 'Anti-14, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-18C, Pre-booster [N=43;68;125]', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}, {'title': 'Anti-18C, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19F, Pre-booster [N=43;68;125]', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19F, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Anti-23F, Pre-booster [N=43;69;123]', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}]}, {'title': 'Anti-23F, Post-booster [N=42;66;119]', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seroprotected subjects was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). 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booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-1, Pre-booster [N=43;66;121]', 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.2'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.18'}, {'value': '0.17', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.21'}]}]}, {'title': 'Anti-1, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '1.57', 'groupId': 'OG000', 'lowerLimit': '1.20', 'upperLimit': '2.05'}, {'value': '1.74', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '2.15'}, {'value': '1.98', 'groupId': 'OG002', 'lowerLimit': '1.66', 'upperLimit': '2.37'}]}]}, {'title': 'Anti-4, Pre-booster [N=43;69;123]', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.35'}, {'value': '0.24', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.30'}, {'value': '0.30', 'groupId': 'OG002', 'lowerLimit': '0.25', 'upperLimit': '0.35'}]}]}, {'title': 'Anti-4, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000', 'lowerLimit': '2.31', 'upperLimit': '3.85'}, {'value': '3.67', 'groupId': 'OG001', 'lowerLimit': '3.07', 'upperLimit': '4.39'}, {'value': '4.23', 'groupId': 'OG002', 'lowerLimit': '3.67', 'upperLimit': '4.88'}]}]}, {'title': 'Anti-5, Pre-booster [N=43;68;124]', 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.33'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '0.34'}, {'value': '0.40', 'groupId': 'OG002', 'lowerLimit': '0.34', 'upperLimit': '0.48'}]}]}, {'title': 'Anti-5, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '1.84', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '2.38'}, {'value': '2.38', 'groupId': 'OG001', 'lowerLimit': '1.93', 'upperLimit': '2.94'}, {'value': '2.58', 'groupId': 'OG002', 'lowerLimit': '2.20', 'upperLimit': '3.02'}]}]}, {'title': 'Anti-6B, Pre-booster [N=43;67;124]', 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '0.38'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.37'}, {'value': '0.37', 'groupId': 'OG002', 'lowerLimit': '0.31', 'upperLimit': '0.45'}]}]}, {'title': 'Anti-6B, Post-booster [N=42;66;119]', 'categories': [{'measurements': [{'value': '2.44', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '3.17'}, {'value': '2.46', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '3.06'}, {'value': '2.67', 'groupId': 'OG002', 'lowerLimit': '2.27', 'upperLimit': '3.13'}]}]}, {'title': 'Anti-7F, Pre-booster [N=43;65;123]', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '0.56'}, {'value': '0.46', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.58'}, {'value': '0.66', 'groupId': 'OG002', 'lowerLimit': '0.57', 'upperLimit': '0.77'}]}]}, {'title': 'Anti-7F, Post-booster [N=43;66;118]', 'categories': [{'measurements': [{'value': '3.11', 'groupId': 'OG000', 'lowerLimit': '2.48', 'upperLimit': '3.90'}, {'value': '4.16', 'groupId': 'OG001', 'lowerLimit': '3.52', 'upperLimit': '4.90'}, {'value': '3.93', 'groupId': 'OG002', 'lowerLimit': '3.45', 'upperLimit': '4.47'}]}]}, {'title': 'Anti-9V, Pre-booster [N=43;69;123]', 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '0.67'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '0.35', 'upperLimit': '0.52'}, {'value': '0.59', 'groupId': 'OG002', 'lowerLimit': '0.51', 'upperLimit': '0.69'}]}]}, {'title': 'Anti-9V, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '2.87', 'groupId': 'OG000', 'lowerLimit': '2.23', 'upperLimit': '3.70'}, {'value': '3.47', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '4.20'}, {'value': '4.17', 'groupId': 'OG002', 'lowerLimit': '3.60', 'upperLimit': '4.83'}]}]}, {'title': 'Anti-14, Pre-booster [N=43;68;124]', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '1.11'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.61'}, {'value': '0.68', 'groupId': 'OG002', 'lowerLimit': '0.55', 'upperLimit': '0.84'}]}]}, {'title': 'Anti-14, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '4.88', 'groupId': 'OG000', 'lowerLimit': '3.42', 'upperLimit': '6.98'}, {'value': '5.14', 'groupId': 'OG001', 'lowerLimit': '4.22', 'upperLimit': '6.25'}, {'value': '5.98', 'groupId': 'OG002', 'lowerLimit': '5.10', 'upperLimit': '7.02'}]}]}, {'title': 'Anti-18C, Pre-booster [N=43;68;125]', 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.80'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.45', 'upperLimit': '0.70'}, {'value': '0.60', 'groupId': 'OG002', 'lowerLimit': '0.49', 'upperLimit': '0.73'}]}]}, {'title': 'Anti-18C, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '9.51', 'groupId': 'OG000', 'lowerLimit': '7.36', 'upperLimit': '12.29'}, {'value': '13.20', 'groupId': 'OG001', 'lowerLimit': '10.97', 'upperLimit': '15.89'}, {'value': '12.38', 'groupId': 'OG002', 'lowerLimit': '10.21', 'upperLimit': '15.00'}]}]}, {'title': 'Anti-19F, Pre-booster [N=43;68;125]', 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '1.30'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '1.46'}, {'value': '1.27', 'groupId': 'OG002', 'lowerLimit': '1.02', 'upperLimit': '1.59'}]}]}, {'title': 'Anti-19F, Post-booster [N=43;66;119]', 'categories': [{'measurements': [{'value': '6.83', 'groupId': 'OG000', 'lowerLimit': '5.24', 'upperLimit': '8.89'}, {'value': '9.78', 'groupId': 'OG001', 'lowerLimit': '8.19', 'upperLimit': '11.68'}, {'value': '9.72', 'groupId': 'OG002', 'lowerLimit': '8.38', 'upperLimit': '11.29'}]}]}, {'title': 'Anti-23F, Pre-booster [N=43;69;123]', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.36'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.38'}, {'value': '0.42', 'groupId': 'OG002', 'lowerLimit': '0.35', 'upperLimit': '0.51'}]}]}, {'title': 'Anti-23F, Post-booster [N=42;66;119]', 'categories': [{'measurements': [{'value': '2.70', 'groupId': 'OG000', 'lowerLimit': '1.91', 'upperLimit': '3.81'}, {'value': '3.45', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '4.06'}, {'value': '3.30', 'groupId': 'OG002', 'lowerLimit': '2.74', 'upperLimit': '3.99'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine 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10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-6A, Pre-booster [N=42;67;122]', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6A, Post-booster [N=42;66;118]', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19A, Pre-booster [N=43;67;121]', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19A, Post-booster [N=42;66;118]', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': 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months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-6A, Pre-booster [N=42;67;122]', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.17'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.16'}, {'value': '0.14', 'groupId': 'OG002', 'lowerLimit': '0.12', 'upperLimit': '0.18'}]}]}, {'title': 'Anti-6A, Post-booster [N=42;66;118]', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '1.05'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '1.07'}, {'value': '0.79', 'groupId': 'OG002', 'lowerLimit': '0.61', 'upperLimit': '1.02'}]}]}, {'title': 'Anti-19A, Pre-booster [N=43;67;121]', 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.24'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.22'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.12', 'upperLimit': '0.22'}]}]}, {'title': 'Anti-19A, Post-booster [N=42;66;118]', 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.40', 'upperLimit': '1.04'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '1.37'}, {'value': '1.10', 'groupId': 'OG002', 'lowerLimit': '0.82', 'upperLimit': '1.47'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Protein D Antibodies (Anti-PD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PD, Pre-booster [N=42;67;123]', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PD, Post-booster [N=43;66;118]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Protein D (Anti-PD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PD, Pre-booster [N=42;67;123]', 'categories': [{'measurements': [{'value': '478.3', 'groupId': 'OG000', 'lowerLimit': '361.4', 'upperLimit': '633.1'}, {'value': '340.0', 'groupId': 'OG001', 'lowerLimit': '258.1', 'upperLimit': '447.9'}, {'value': '383.7', 'groupId': 'OG002', 'lowerLimit': '317.6', 'upperLimit': '463.5'}]}]}, {'title': 'Anti-PD, Post-booster [N=43;66;118]', 'categories': [{'measurements': [{'value': '1892.9', 'groupId': 'OG000', 'lowerLimit': '1415.1', 'upperLimit': '2532.2'}, {'value': '1576.5', 'groupId': 'OG001', 'lowerLimit': '1232.7', 'upperLimit': '2016.1'}, {'value': '1533.6', 'groupId': 'OG002', 'lowerLimit': '1278.2', 'upperLimit': '1840.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-protein D (Anti-PD) antibody concentrations greater than or equal to (≥) 100 ELISA units per milliliter (EL.U/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-DT, Pre-booster [N=23;31;59]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Anti-DT, Post-booster [N=21;34;60]', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Anti-TT, Pre-booster [N=23;32;59]', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'Anti-TT, Post-booster [N=21;34;60]', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-DT, Pre-booster [N=23;31;59]', 'categories': [{'measurements': [{'value': '0.381', 'groupId': 'OG000', 'lowerLimit': '0.210', 'upperLimit': '0.689'}, {'value': '0.674', 'groupId': 'OG001', 'lowerLimit': '0.380', 'upperLimit': '1.196'}, {'value': '0.481', 'groupId': 'OG002', 'lowerLimit': '0.324', 'upperLimit': '0.716'}]}]}, {'title': 'Anti-DT, Post-booster [N=21;34;60]', 'categories': [{'measurements': [{'value': '6.252', 'groupId': 'OG000', 'lowerLimit': '4.572', 'upperLimit': '8.551'}, {'value': '9.982', 'groupId': 'OG001', 'lowerLimit': '7.392', 'upperLimit': '13.478'}, {'value': '6.730', 'groupId': 'OG002', 'lowerLimit': '5.254', 'upperLimit': '8.620'}]}]}, {'title': 'Anti-TT, Pre-booster [N=23;32;59]', 'categories': [{'measurements': [{'value': '0.821', 'groupId': 'OG000', 'lowerLimit': '0.591', 'upperLimit': '1.141'}, {'value': '0.726', 'groupId': 'OG001', 'lowerLimit': '0.601', 'upperLimit': '0.877'}, {'value': '0.918', 'groupId': 'OG002', 'lowerLimit': '0.711', 'upperLimit': '1.184'}]}]}, {'title': 'Anti-TT, Post-booster [N=21;34;60]', 'categories': [{'measurements': [{'value': '12.374', 'groupId': 'OG000', 'lowerLimit': '9.629', 'upperLimit': '15.903'}, {'value': '14.392', 'groupId': 'OG001', 'lowerLimit': '11.717', 'upperLimit': '17.676'}, {'value': '13.026', 'groupId': 'OG002', 'lowerLimit': '11.176', 'upperLimit': '15.183'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-diphtheria toxoid (Anti-DT) and anti-tetanus toxoid (Anti-TT) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PRP, Pre-booster [N=23;32;59]', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRP, Post-booster [N=20;34;59]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PRP, Pre-booster [N=23;32;59]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRP, Post-booster [N=20;34;59]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PRP, Pre-booster [N=23;32;59]', 'categories': [{'measurements': [{'value': '0.376', 'groupId': 'OG000', 'lowerLimit': '0.196', 'upperLimit': '0.719'}, {'value': '0.509', 'groupId': 'OG001', 'lowerLimit': '0.312', 'upperLimit': '0.832'}, {'value': '0.577', 'groupId': 'OG002', 'lowerLimit': '0.372', 'upperLimit': '0.896'}]}]}, {'title': 'Anti-PRP, Post-booster [N=20;34;59]', 'categories': [{'measurements': [{'value': '33.731', 'groupId': 'OG000', 'lowerLimit': '17.907', 'upperLimit': '63.540'}, {'value': '36.902', 'groupId': 'OG001', 'lowerLimit': '25.148', 'upperLimit': '54.148'}, {'value': '38.713', 'groupId': 'OG002', 'lowerLimit': '27.736', 'upperLimit': '54.034'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg /mL) and ≥ 1.0 µg/mL. Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PT, Pre-booster [N=22;32;58]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PT, Post-booster [N=21;34;59]', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA, Pre-booster [N=20;27;47]', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA, Post-booster [N=21;34;59]', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN, Pre-booster [N=23;32;59]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN, Post-booster [N=21;34;60]', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PT, Pre-booster [N=22;32;58]', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '9.8'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '4.7'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '4.4', 'upperLimit': '6.9'}]}]}, {'title': 'Anti-PT, Post-booster [N=21;34;59]', 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '49.5'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '24.2', 'upperLimit': '44.2'}, {'value': '45.1', 'groupId': 'OG002', 'lowerLimit': '37.0', 'upperLimit': '54.9'}]}]}, {'title': 'Anti-FHA, Pre-booster [N=20;27;47]', 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '84.2'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '20.1'}, {'value': '17.0', 'groupId': 'OG002', 'lowerLimit': '12.4', 'upperLimit': '23.3'}]}]}, {'title': 'Anti-FHA, Post-booster [N=21;34;59]', 'categories': [{'measurements': [{'value': '250.3', 'groupId': 'OG000', 'lowerLimit': '162.4', 'upperLimit': '385.8'}, {'value': '275.3', 'groupId': 'OG001', 'lowerLimit': '207.0', 'upperLimit': '366.1'}, {'value': '229.0', 'groupId': 'OG002', 'lowerLimit': '188.1', 'upperLimit': '278.9'}]}]}, {'title': 'Anti-PRN, Pre-booster [N=23;32;59]', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '29.9'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '14.2'}, {'value': '11.3', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '14.8'}]}]}, {'title': 'Anti-PRN, Post-booster [N=21;34;60]', 'categories': [{'measurements': [{'value': '259.7', 'groupId': 'OG000', 'lowerLimit': '151.5', 'upperLimit': '445.2'}, {'value': '286.5', 'groupId': 'OG001', 'lowerLimit': '192.6', 'upperLimit': '426.0'}, {'value': '264.5', 'groupId': 'OG002', 'lowerLimit': '200.2', 'upperLimit': '349.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U /mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-PT, S- [N=11;21;27]', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PT, S+ [N=9;11;27]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA, S- [N=1;3;4]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA, S+ [N=17;24;39]', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN, S- [N=2;4;11]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN, S+ [N=19;28;45]', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Vaccine response was defined as antibody concentrations ≥ 5 EL.U/mL at post-booster, for initially seronegative subjects (S-) (with concentrations \\< 5 EL.U/mL) and for initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL), antibody concentrations at post-booster ≥ 2 fold the pre-vaccination antibody concentration.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-Polio 1, Pre-booster [N=17;29;53]', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Anti-Polio 1, Post-booster [N=3;8;20]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Anti-Polio 2, Pre-booster [N=17;29;53]', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Anti-Polio 2, Post-booster [N=3;8;20]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Anti-Polio 3, Pre-booster [N=17;29;53]', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Anti-Polio 3, Post-booster [N=3;8;20]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Titers Against Anti-polio Type 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'Anti-Polio 1, Pre-booster [N=17;29;53]', 'categories': [{'measurements': [{'value': '52.3', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '87.6'}, {'value': '34.8', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '62.7'}, {'value': '54.7', 'groupId': 'OG002', 'lowerLimit': '37.7', 'upperLimit': '79.3'}]}]}, {'title': 'Anti-Polio 1, Post-booster [N=3;8;20]', 'categories': [{'measurements': [{'value': '512.0', 'groupId': 'OG000', 'lowerLimit': '115.3', 'upperLimit': '2274.0'}, {'value': '1386.7', 'groupId': 'OG001', 'lowerLimit': '456.6', 'upperLimit': '4210.9'}, {'value': '1327.9', 'groupId': 'OG002', 'lowerLimit': '795.4', 'upperLimit': '2217.1'}]}]}, {'title': 'Anti-Polio 2, Pre-booster [N=17;29;53]', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '37.4', 'upperLimit': '113.7'}, {'value': '47.3', 'groupId': 'OG001', 'lowerLimit': '26.2', 'upperLimit': '85.3'}, {'value': '50.9', 'groupId': 'OG002', 'lowerLimit': '33.7', 'upperLimit': '76.7'}]}]}, {'title': 'Anti-Polio 2, Post-booster [N=3;8;20]', 'categories': [{'measurements': [{'value': '1290.1', 'groupId': 'OG000', 'lowerLimit': '147.8', 'upperLimit': '11259.3'}, {'value': '2048.0', 'groupId': 'OG001', 'lowerLimit': '759.7', 'upperLimit': '5520.9'}, {'value': '1116.9', 'groupId': 'OG002', 'lowerLimit': '600.9', 'upperLimit': '2076.1'}]}]}, {'title': 'Anti-Polio 3, Pre-booster [N=17;29;53]', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '53.2'}, {'value': '31.3', 'groupId': 'OG001', 'lowerLimit': '16.8', 'upperLimit': '58.4'}, {'value': '84.3', 'groupId': 'OG002', 'lowerLimit': '59.0', 'upperLimit': '120.4'}]}]}, {'title': 'Anti-Polio 3, Post-booster [N=3;8;20]', 'categories': [{'measurements': [{'value': '574.7', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '9148.9'}, {'value': '1448.1', 'groupId': 'OG001', 'lowerLimit': '464.0', 'upperLimit': '4519.2'}, {'value': '1692.5', 'groupId': 'OG002', 'lowerLimit': '1147.7', 'upperLimit': '2495.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seroprotection status was defined as the anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers greater than or equal to (≥) the cut-off value of 8, presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '246.8'}, {'value': '117.2', 'groupId': 'OG001', 'lowerLimit': '117.2', 'upperLimit': '117.2'}, {'value': '37.2', 'groupId': 'OG002', 'lowerLimit': '15.6', 'upperLimit': '88.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seroprotection status was defined as the Anti-HBs antibody concentrations greater than or equal to (≥) 10 milli international units per milliliter (mIU/mL), presented as geometric mean concentrations (GMCs).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'OPA Anti-1, [N=37;52;99]', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-4, [N=36;55;100]', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-5, [N=34;50;93]', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-6B, [N=35;51;98]', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-7F, [N=37;49;99]', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-9V, [N=38;47;100]', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-14, [N=36;52;99]', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-18C, [N=37;50;100]', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-19F, [N=36;52;96]', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-23F, [N=37;54;99]', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'OPA Anti-1, [N=37;52;99]', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '74.1', 'upperLimit': '210.8'}, {'value': '143.6', 'groupId': 'OG001', 'lowerLimit': '93.1', 'upperLimit': '221.3'}, {'value': '170.9', 'groupId': 'OG002', 'lowerLimit': '124.6', 'upperLimit': '234.3'}]}]}, {'title': 'OPA Anti-4, [N=36;55;100]', 'categories': [{'measurements': [{'value': '971.8', 'groupId': 'OG000', 'lowerLimit': '623.7', 'upperLimit': '1514.1'}, {'value': '1307.2', 'groupId': 'OG001', 'lowerLimit': '1070.0', 'upperLimit': '1596.9'}, {'value': '1479.3', 'groupId': 'OG002', 'lowerLimit': '1259.6', 'upperLimit': '1737.3'}]}]}, {'title': 'OPA Anti-5, [N=34;50;93]', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '106.4'}, {'value': '120.0', 'groupId': 'OG001', 'lowerLimit': '81.2', 'upperLimit': '177.1'}, {'value': '176.9', 'groupId': 'OG002', 'lowerLimit': '138.1', 'upperLimit': '226.5'}]}]}, {'title': 'OPA Anti-6B, [N=35;51;98]', 'categories': [{'measurements': [{'value': '659.0', 'groupId': 'OG000', 'lowerLimit': '353.9', 'upperLimit': '1227.3'}, {'value': '459.1', 'groupId': 'OG001', 'lowerLimit': '286.7', 'upperLimit': '735.3'}, {'value': '635.0', 'groupId': 'OG002', 'lowerLimit': '437.3', 'upperLimit': '922.1'}]}]}, {'title': 'OPA Anti-7F, [N=37;49;99]', 'categories': [{'measurements': [{'value': '6008.9', 'groupId': 'OG000', 'lowerLimit': '4318.7', 'upperLimit': '8360.5'}, {'value': '4851.1', 'groupId': 'OG001', 'lowerLimit': '3954.4', 'upperLimit': '5951.1'}, {'value': '4372.6', 'groupId': 'OG002', 'lowerLimit': '3658.8', 'upperLimit': '5225.5'}]}]}, {'title': 'OPA Anti-9V, [N=38;47;100]', 'categories': [{'measurements': [{'value': '1666.4', 'groupId': 'OG000', 'lowerLimit': '1218.1', 'upperLimit': '2279.6'}, {'value': '2192.5', 'groupId': 'OG001', 'lowerLimit': '1724.3', 'upperLimit': '2787.8'}, {'value': '1798.8', 'groupId': 'OG002', 'lowerLimit': '1522.8', 'upperLimit': '2124.7'}]}]}, {'title': 'OPA Anti-14, [N=36;52;99]', 'categories': [{'measurements': [{'value': '1489.5', 'groupId': 'OG000', 'lowerLimit': '980.7', 'upperLimit': '2262.3'}, {'value': '1895.3', 'groupId': 'OG001', 'lowerLimit': '1477.3', 'upperLimit': '2431.7'}, {'value': '1342.7', 'groupId': 'OG002', 'lowerLimit': '1095.4', 'upperLimit': '1646.0'}]}]}, {'title': 'OPA Anti-18C, [N=37;50;100]', 'categories': [{'measurements': [{'value': '1656.0', 'groupId': 'OG000', 'lowerLimit': '1005.6', 'upperLimit': '2727.0'}, {'value': '1672.4', 'groupId': 'OG001', 'lowerLimit': '1154.4', 'upperLimit': '2422.9'}, {'value': '1561.9', 'groupId': 'OG002', 'lowerLimit': '1251.2', 'upperLimit': '1949.8'}]}]}, {'title': 'OPA Anti-19F, [N=36;52;96]', 'categories': [{'measurements': [{'value': '379.3', 'groupId': 'OG000', 'lowerLimit': '241.3', 'upperLimit': '596.2'}, {'value': '486.3', 'groupId': 'OG001', 'lowerLimit': '327.9', 'upperLimit': '721.3'}, {'value': '626.8', 'groupId': 'OG002', 'lowerLimit': '473.1', 'upperLimit': '830.3'}]}]}, {'title': 'OPA Anti-23F, [N=37;54;99]', 'categories': [{'measurements': [{'value': '2881.8', 'groupId': 'OG000', 'lowerLimit': '1956.7', 'upperLimit': '4244.3'}, {'value': '2510.2', 'groupId': 'OG001', 'lowerLimit': '2076.2', 'upperLimit': '3035.0'}, {'value': '3208.6', 'groupId': 'OG002', 'lowerLimit': '2667.3', 'upperLimit': '3859.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'OPA Anti-6A, [N=34;50;95]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}, {'title': 'OPA Anti-19A, [N=38;52;95]', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'OG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'classes': [{'title': 'OPA Anti-6A, [N=34;50;95]', 'categories': [{'measurements': [{'value': '270.6', 'groupId': 'OG000', 'lowerLimit': '152.9', 'upperLimit': '478.6'}, {'value': '218.2', 'groupId': 'OG001', 'lowerLimit': '137.4', 'upperLimit': '346.6'}, {'value': '207.4', 'groupId': 'OG002', 'lowerLimit': '136.8', 'upperLimit': '314.4'}]}]}, {'title': 'OPA Anti-19A, [N=38;52;95]', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '63.6'}, {'value': '41.4', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '77.8'}, {'value': '51.7', 'groupId': 'OG002', 'lowerLimit': '32.1', 'upperLimit': '83.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'FG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'FG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'BG001', 'title': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'BG002', 'title': 'Full Term Group', 'description': 'Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'spread': '0.63', 'groupId': 'BG000'}, {'value': '17.2', 'spread': '0.68', 'groupId': 'BG001'}, {'value': '16.6', 'spread': '0.73', 'groupId': 'BG002'}, {'value': '16.81', 'spread': '0.74', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], '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': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2009-09-09', 'completionDateStruct': {'date': '2009-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-30', 'studyFirstSubmitDate': '2008-01-25', 'dispFirstSubmitQcDate': '2009-09-09', 'resultsFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2008-01-25', 'dispFirstPostDateStruct': {'date': '2009-09-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-01', 'studyFirstPostDateStruct': {'date': '2008-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)', 'timeFrame': 'Within 4-days (Day 0-3) after booster vaccination', 'description': 'Fever was measured as rectal temperature. Assessment of occurrences of fever \\> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'Within 4-days (Day 0-3) after booster vaccination', 'description': 'Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited General Symptoms', 'timeFrame': 'Within 4-days (Day 0-3) after booster vaccination', 'description': 'Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 31-days (Day 0-30) after booster vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'Throughout the active phase of the study (Month 0 to Month 1)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Seropositive Subjects for Anti-pneumococcal Serotypes', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).'}, {'measure': 'Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seroprotected subjects was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The anti-pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotypes', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).'}, {'measure': 'Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).'}, {'measure': 'Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).'}, {'measure': 'Number of Seropositive Subjects for Protein D Antibodies (Anti-PD)', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL).'}, {'measure': 'Antibody Concentrations Against Protein D (Anti-PD)', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-protein D (Anti-PD) antibody concentrations greater than or equal to (≥) 100 ELISA units per milliliter (EL.U/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).'}, {'measure': 'Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL).'}, {'measure': 'Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-diphtheria toxoid (Anti-DT) and anti-tetanus toxoid (Anti-TT) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).'}, {'measure': 'Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP)', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL).'}, {'measure': 'Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL).'}, {'measure': 'Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP)', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg /mL) and ≥ 1.0 µg/mL. Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).'}, {'measure': 'Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL).'}, {'measure': 'Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U /mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).'}, {'measure': 'Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Vaccine response was defined as antibody concentrations ≥ 5 EL.U/mL at post-booster, for initially seronegative subjects (S-) (with concentrations \\< 5 EL.U/mL) and for initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL), antibody concentrations at post-booster ≥ 2 fold the pre-vaccination antibody concentration.'}, {'measure': 'Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3)', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8.'}, {'measure': 'Antibody Titers Against Anti-polio Type 1, 2 and 3', 'timeFrame': 'Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seroprotection status was defined as the anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers greater than or equal to (≥) the cut-off value of 8, presented as geometric mean titers (GMTs).'}, {'measure': 'Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs)', 'timeFrame': 'Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seroprotection status was defined as the Anti-HBs antibody concentrations greater than or equal to (≥) 10 milli international units per milliliter (mIU/mL), presented as geometric mean concentrations (GMCs).'}, {'measure': 'Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.'}, {'measure': 'Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).'}, {'measure': 'Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8.'}, {'measure': 'Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'timeFrame': 'One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine', 'description': 'Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).'}]}, 'conditionsModule': {'conditions': ['Infections, Streptococcal', 'Streptococcus Pneumoniae Vaccines']}, 'referencesModule': {'availIpds': [{'id': '109621', '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': '109621', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109621', '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': '109621', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109621', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109621', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109621', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '21727108', 'type': 'BACKGROUND', 'citation': 'Omenaca F, Merino JM, Tejedor JC, Constantopoulos A, Papaevangelou V, Kafetzis D, Tsirka A, Athanassiadou F, Anagnostakou M, Francois N, Borys D, Schuerman L. Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. Pediatrics. 2011 Aug;128(2):e290-8. doi: 10.1542/peds.2010-1184. Epub 2011 Jul 4.'}, {'type': 'BACKGROUND', 'citation': 'Omenaca F et al. Booster vaccination of preterm-born children with 10-valent pneumococcal non-typeable haemophilus influenzae protein D-conjugate vaccine (PHiD-CV): antibody responses and safety. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Beunos Aires, Argentina, 18-22 November 2009.'}, {'type': 'BACKGROUND', 'citation': 'Omenaca F et al. Immunogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) following primary and booster vaccination in preterm-born children. Abstract presented at Excellence In Paediatrics. Florence, Italy, 3-6 December 2009.'}], '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 study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. This protocol posting deals with objectives \\& outcome measures of the booster phase. The objectives \\& outcome measures of the primary phase are presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '16 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.\n* A male or female between, and including, 16-18 months of age at the time of the booster vaccination.\n* A male or female who previously participated in study 107737 and received three doses of pneumococcal conjugate vaccine.\n* Written informed consent obtained from the parent or guardian of the subject.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n\nExclusion Criteria:\n\n* Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).\n* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine.\n* Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2).\n* Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 107737\n* History of or intercurrent diphtheria, tetanus, hepatitis B, pertussis, polio, Haemophilus influenzae type b disease.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* History of seizures or progressive neurological disease\n* Acute disease at the time of enrolment.\n* Febrile illness defined as oral, axillary or tympanic temperature \\< 37.5°C / rectal temperature \\< 38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.\n* A family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or serious chronic illness.\n* Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.'}, 'identificationModule': {'nctId': 'NCT00609492', 'briefTitle': 'Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Safety, Reactogenicity and Immunogenicity Following Booster Dose of GSK Biologicals´ Pneumococcal Conjugate Vaccine When Co-administered With a Booster Dose of Infanrix-IPV/Hib in Preterm Born Children at 16-18 Months of Age', 'orgStudyIdInfo': {'id': '109621'}, 'secondaryIdInfos': [{'id': '2007-000596-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preterm I Group', 'description': 'Children born after a gestation period of 27-30 weeks', 'interventionNames': ['Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)', 'Biological: Infanrix™-IPV/Hib']}, {'type': 'EXPERIMENTAL', 'label': 'Preterm II Group', 'description': 'Children born after a gestation period of 31-36 weeks', 'interventionNames': ['Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)', 'Biological: Infanrix™-IPV/Hib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Full term Group', 'description': 'Children born after a gestation period of more than 36 weeks', 'interventionNames': ['Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)', 'Biological: Infanrix™-IPV/Hib']}], 'interventions': [{'name': 'GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)', 'type': 'BIOLOGICAL', 'description': 'Single dose, intramuscular injection', 'armGroupLabels': ['Full term Group', 'Preterm I Group', 'Preterm II Group']}, {'name': 'Infanrix™-IPV/Hib', 'type': 'BIOLOGICAL', 'description': 'Single dose, intramuscular injection', 'armGroupLabels': ['Full term Group', 'Preterm I Group', 'Preterm II Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115 27', 'city': 'Athens', 'country': 'Greece', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '452 21', 'city': 'Ioannina', 'country': 'Greece', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'zip': '54636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '09005', 'city': 'Burgos', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '28047', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28935', 'city': 'Móstoles/Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=255', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}