Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 2:48 PM
Study NCT ID:
NCT00950833
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2009-07-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D011008', 'term': 'Pneumococcal 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}}, 'adverseEventsModule': {'timeFrame': 'Solicited symptoms: during the 4-day (Days 0-3) follow-up periods after vaccination. Unsolicited AEs: within the 31-day (Days 0-30) follow-up periods after vaccination. SAEs: during the entire study period (from Day 0 up to Month 10/12).', 'eventGroups': [{'id': 'EG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 96, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 86, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 190, 'seriousNumAtRisk': 223, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 167}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 127}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 101}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 98}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fever/(Axillary)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibody Concentrations Against Vaccine Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': 'Anti-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '1.42'}, {'value': '7.63', 'groupId': 'OG001', 'lowerLimit': '6.57', 'upperLimit': '8.86'}]}]}, {'title': 'Anti-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.52', 'groupId': 'OG000', 'lowerLimit': '3.96', 'upperLimit': '5.17'}, {'value': '12.95', 'groupId': 'OG001', 'lowerLimit': '11.37', 'upperLimit': '14.75'}]}]}, {'title': 'Anti-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.84'}, {'value': '9.76', 'groupId': 'OG001', 'lowerLimit': '8.44', 'upperLimit': '11.29'}]}]}, {'title': 'Anti-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.33'}, {'value': '7.67', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '8.78'}]}]}, {'title': 'Anti-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '1.19', 'upperLimit': '1.58'}, {'value': '6.51', 'groupId': 'OG001', 'lowerLimit': '5.69', 'upperLimit': '7.46'}]}]}, {'title': 'Anti-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '0.83'}, {'value': '9.75', 'groupId': 'OG001', 'lowerLimit': '8.46', 'upperLimit': '11.24'}]}]}, {'title': 'Anti-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.27'}, {'value': '23.07', 'groupId': 'OG001', 'lowerLimit': '20.03', 'upperLimit': '26.57'}]}]}, {'title': 'Anti-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.25', 'groupId': 'OG000', 'lowerLimit': '2.71', 'upperLimit': '3.9'}, {'value': '32.54', 'groupId': 'OG001', 'lowerLimit': '28.15', 'upperLimit': '37.61'}]}]}, {'title': 'Anti-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.31', 'groupId': 'OG000', 'lowerLimit': '3.59', 'upperLimit': '5.17'}, {'value': '39.84', 'groupId': 'OG001', 'lowerLimit': '34.12', 'upperLimit': '46.51'}]}]}, {'title': 'Anti-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.32'}, {'value': '9.24', 'groupId': 'OG001', 'lowerLimit': '7.86', 'upperLimit': '10.86'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-1', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.17', 'ciLowerLimit': '5.03', 'ciUpperLimit': '7.58', 'groupDescription': 'To demonstrate the immunological memory induced for anti-pneumococcal serotype 1 following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 1.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-4', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.86', 'ciLowerLimit': '2.38', 'ciUpperLimit': '3.45', 'groupDescription': 'To demonstrate the immunological memory for anti-pneumococcal serotype 4 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled SynflorixI+II Group over Synflorix Group) was higher than 1 for pneumococcal serotype 4.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-5', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.47', 'ciLowerLimit': '10.96', 'ciUpperLimit': '16.55', 'groupDescription': 'To demonstrate the immunological memory for anti-pneumococcal serotype 5 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-6B', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.81', 'ciLowerLimit': '22.54', 'ciUpperLimit': '36.81', 'groupDescription': 'To demonstrate the immunological memory for anti-pneumococcal serotype 6B induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 6B.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-7F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.75', 'ciLowerLimit': '3.9', 'ciUpperLimit': '5.78', 'groupDescription': 'To demonstrate the immunological memory for anti-pneumococcal serotype 7F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 7F.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-9V', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.1', 'ciLowerLimit': '11.21', 'ciUpperLimit': '17.75', 'groupDescription': 'To demonstrate the immunological memory for anti-pneumococcal serotype 9V induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 9V.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-14', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.92', 'ciLowerLimit': '17.51', 'ciUpperLimit': '30', 'groupDescription': 'To demonstrate the immunological memory for anti-pneumococcal serotype 14 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 14.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-18C', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.01', 'ciLowerLimit': '7.95', 'ciUpperLimit': '12.61', 'groupDescription': 'To demonstrate the immunological memory for anti-pneumococcal serotype 18C induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 18C.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-19F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.25', 'ciLowerLimit': '7.29', 'ciUpperLimit': '11.74', 'groupDescription': 'To demonstrate the immunological memory for anti-pneumococcal serotype 19F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 19F.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio for anti-23F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.52', 'ciLowerLimit': '27.59', 'ciUpperLimit': '48.34', 'groupDescription': 'To demonstrate the immunological memory for anti-pneumococcal serotype 23F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 23F.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 7-10 days after the first vaccine dose', 'description': 'Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Vaccine Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': 'Anti-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.11'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.33'}]}]}, {'title': 'Anti-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.06'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.23'}]}]}, {'title': 'Anti-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.11'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.47'}]}]}, {'title': 'Anti-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.12'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '1.05'}]}]}, {'title': 'Anti-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.07'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.56'}]}]}, {'title': 'Anti-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.09'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.61'}]}]}, {'title': 'Anti-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.36'}, {'value': '1.21', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '1.5'}]}]}, {'title': 'Anti-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.11'}, {'value': '0.65', 'groupId': 'OG001', 'lowerLimit': '0.54', 'upperLimit': '0.79'}]}]}, {'title': 'Anti-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '0.59'}, {'value': '2.35', 'groupId': 'OG001', 'lowerLimit': '1.75', 'upperLimit': '3.15'}]}]}, {'title': 'Anti-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 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'OG001', 'lowerLimit': '10.6', 'upperLimit': '19.2'}]}]}, {'title': 'Opsono-18C, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9092.2', 'groupId': 'OG000', 'lowerLimit': '7381.2', 'upperLimit': '11199.9'}, {'value': '7413.8', 'groupId': 'OG001', 'lowerLimit': '6072.3', 'upperLimit': '9051.6'}]}]}, {'title': 'Opsono-19F, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '17.2'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '113.9'}]}]}, {'title': 'Opsono-19F, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '902.5', 'groupId': 'OG000', 'lowerLimit': '659.2', 'upperLimit': '1235.6'}, {'value': '6271.1', 'groupId': 'OG001', 'lowerLimit': '4814.8', 'upperLimit': '8168'}]}]}, {'title': 'Opsono-23F, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '220.6', 'groupId': 'OG000', 'lowerLimit': '132', 'upperLimit': '368.7'}, {'value': '462.7', 'groupId': 'OG001', 'lowerLimit': '292.9', 'upperLimit': '730.9'}]}]}, {'title': 'Opsono-23F, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5776.5', 'groupId': 'OG000', 'lowerLimit': '4686.8', 'upperLimit': '7119.5'}, {'value': '15613.5', 'groupId': 'OG001', 'lowerLimit': '12386.9', 'upperLimit': '19680.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': 'Anti-6A, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.13'}, {'value': '0.39', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.5'}]}]}, {'title': 'Anti-6A, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.25'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '2.01', 'upperLimit': '2.85'}]}]}, {'title': 'Anti-19A, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.28'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.67'}]}]}, {'title': 'Anti-19A, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '0.82'}, {'value': '6.75', 'groupId': 'OG001', 'lowerLimit': '5.41', 'upperLimit': '8.41'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': 'Opsono-6A, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '74'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '138.7'}]}]}, {'title': 'Opsono-6A, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '863.3', 'groupId': 'OG000', 'lowerLimit': '619.3', 'upperLimit': '1203.4'}, {'value': '2408.4', 'groupId': 'OG001', 'lowerLimit': '1815.7', 'upperLimit': '3194.5'}]}]}, {'title': 'Opsono-19A, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '13.4'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '21.6'}]}]}, {'title': 'Opsono-19A, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '880.5', 'groupId': 'OG000', 'lowerLimit': '622.7', 'upperLimit': '1245'}, {'value': '2104.9', 'groupId': 'OG001', 'lowerLimit': '1560.9', 'upperLimit': '2838.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (Opsono-16A and opsono-19A) ≥ the 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 data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Protein D (Anti-PD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': 'Anti-PD, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '105.6', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '119'}, {'value': '464.2', 'groupId': 'OG001', 'lowerLimit': '401.6', 'upperLimit': '536.5'}]}]}, {'title': 'Anti-PD, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '374.3', 'groupId': 'OG000', 'lowerLimit': '315.1', 'upperLimit': '444.6'}, {'value': '2673.7', 'groupId': 'OG001', 'lowerLimit': '2359.1', 'upperLimit': '3030.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Memory B-cell Detection for Vaccine Polysaccharides (PS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.'}, {'id': 'OG002', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'title': '1 PS, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '288.6', 'spread': '352.5', 'groupId': 'OG000'}, {'value': '269.5', 'spread': '432.2', 'groupId': 'OG001'}, {'value': '254.8', 'spread': '368.4', 'groupId': 'OG002'}]}]}, {'title': '1 PS, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1488.8', 'spread': '1584.2', 'groupId': 'OG000'}, {'value': '1017.4', 'spread': '1309.9', 'groupId': 'OG001'}, {'value': '755.9', 'spread': '1017.4', 'groupId': 'OG002'}]}]}, {'title': '5 PS, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '139.4', 'spread': '214.7', 'groupId': 'OG000'}, {'value': '141.9', 'spread': '232.4', 'groupId': 'OG001'}, {'value': '81.5', 'spread': '109.2', 'groupId': 'OG002'}]}]}, {'title': '5 PS, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '233.5', 'spread': '235.7', 'groupId': 'OG000'}, {'value': '406.6', 'spread': '447.8', 'groupId': 'OG001'}, {'value': '152.6', 'spread': '231', 'groupId': 'OG002'}]}]}, {'title': '6B PS, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '372', 'spread': '545.5', 'groupId': 'OG000'}, {'value': '327.2', 'spread': '554.4', 'groupId': 'OG001'}, {'value': '639.9', 'spread': '846.5', 'groupId': 'OG002'}]}]}, {'title': '6B PS, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '629.1', 'spread': '773.2', 'groupId': 'OG000'}, {'value': '1265.8', 'spread': '1738.6', 'groupId': 'OG001'}, {'value': '526', 'spread': '648.6', 'groupId': 'OG002'}]}]}, {'title': '18C PS, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '537.7', 'spread': '641.8', 'groupId': 'OG000'}, {'value': '530.9', 'spread': '693.8', 'groupId': 'OG001'}, {'value': '135.2', 'spread': '200.6', 'groupId': 'OG002'}]}]}, {'title': '18C PS, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3839', 'spread': '5960.5', 'groupId': 'OG000'}, {'value': '8308.4', 'spread': '7166.9', 'groupId': 'OG001'}, {'value': '2053.8', 'spread': '2122.2', 'groupId': 'OG002'}]}]}, {'title': '19F PS, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '169.7', 'spread': '415.3', 'groupId': 'OG000'}, {'value': '149.1', 'spread': '194.4', 'groupId': 'OG001'}, {'value': '164.5', 'spread': '343.4', 'groupId': 'OG002'}]}]}, {'title': '19F PS, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1056.7', 'spread': '1334', 'groupId': 'OG000'}, {'value': '1092.4', 'spread': '1724.3', 'groupId': 'OG001'}, {'value': '708.2', 'spread': '1609.4', 'groupId': 'OG002'}]}]}, {'title': '23F PS, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '112.6', 'spread': '176.1', 'groupId': 'OG000'}, {'value': '285', 'spread': '484.3', 'groupId': 'OG001'}, {'value': '185.6', 'spread': '270.1', 'groupId': 'OG002'}]}]}, {'title': '23F PS, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '579.8', 'spread': '632.5', 'groupId': 'OG000'}, {'value': '1123.7', 'spread': '2095.4', 'groupId': 'OG001'}, {'value': '327.9', 'spread': '470.5', 'groupId': 'OG002'}]}]}, {'title': 'C-PS, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '475.9', 'spread': '682.3', 'groupId': 'OG000'}, {'value': '462.5', 'spread': '704.5', 'groupId': 'OG001'}, {'value': '469.9', 'spread': '639.2', 'groupId': 'OG002'}]}]}, {'title': 'C-PS, D7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '679.2', 'spread': '885.8', 'groupId': 'OG000'}, {'value': '915.5', 'spread': '1191.3', 'groupId': 'OG001'}, {'value': '762.6', 'spread': '1039.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'B-cell detection for the pneumococcal serotype specific polysaccharides (1, 5, 6B, 18C, 19F, 23F and C) was tabulated for a subset of subjects from each group. The results are expressed as the frequencies of antigen-specific memory B-cells within the total memory B-cell population.', 'unitOfMeasure': 'Memory B-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Vaccine Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'title': 'Anti-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG000', 'lowerLimit': '2.13', 'upperLimit': '2.54'}]}]}, {'title': 'Anti-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.26', 'groupId': 'OG000', 'lowerLimit': '5.73', 'upperLimit': '6.84'}]}]}, {'title': 'Anti-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.69', 'groupId': 'OG000', 'lowerLimit': '2.44', 'upperLimit': '2.96'}]}]}, {'title': 'Anti-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '0.97'}]}]}, {'title': 'Anti-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.63', 'groupId': 'OG000', 'lowerLimit': '3.33', 'upperLimit': '3.95'}]}]}, {'title': 'Anti-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '1.93'}]}]}, {'title': 'Anti-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.21', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '5.89'}]}]}, {'title': 'Anti-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.59', 'groupId': 'OG000', 'lowerLimit': '11.91', 'upperLimit': '15.51'}]}]}, {'title': 'Anti-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.83', 'groupId': 'OG000', 'lowerLimit': '10.35', 'upperLimit': '13.52'}]}]}, {'title': 'Anti-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '1.15'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs), expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'title': 'Opsono-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '125.6', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '150.1'}]}]}, {'title': 'Opsono-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2451.2', 'groupId': 'OG000', 'lowerLimit': '2203.6', 'upperLimit': '2726.8'}]}]}, {'title': 'Opsono-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '69.1'}]}]}, {'title': 'Opsono-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1345', 'groupId': 'OG000', 'lowerLimit': '1066.8', 'upperLimit': '1695.7'}]}]}, {'title': 'Opsono-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6527.2', 'groupId': 'OG000', 'lowerLimit': '5836.5', 'upperLimit': '7299.6'}]}]}, {'title': 'Opsono-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6091.6', 'groupId': 'OG000', 'lowerLimit': '5328.7', 'upperLimit': '6963.8'}]}]}, {'title': 'Opsono-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4544.9', 'groupId': 'OG000', 'lowerLimit': '4030.2', 'upperLimit': '5125.4'}]}]}, {'title': 'Opsono-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3827.5', 'groupId': 'OG000', 'lowerLimit': '3367.5', 'upperLimit': '4350.4'}]}]}, {'title': 'Opsono-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1251', 'groupId': 'OG000', 'lowerLimit': '1045.6', 'upperLimit': '1496.8'}]}]}, {'title': 'Opsono-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4629.1', 'groupId': 'OG000', 'lowerLimit': '3890.6', 'upperLimit': '5507.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'title': 'Anti-6A', 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.6'}]}]}, {'title': 'Anti-19A', 'categories': [{'measurements': [{'value': '1.99', 'groupId': 'OG000', 'lowerLimit': '1.68', 'upperLimit': '2.36'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'title': 'Opsono-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '918.6', 'groupId': 'OG000', 'lowerLimit': '742.7', 'upperLimit': '1136.1'}]}]}, {'title': 'Opsono-19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '597.6', 'groupId': 'OG000', 'lowerLimit': '467.2', 'upperLimit': '764.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (opsono-16A and opsono-19A) ≥ the 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 data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Protein D (Anti-PD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'categories': [{'measurements': [{'value': '785.9', 'groupId': 'OG000', 'lowerLimit': '695.7', 'upperLimit': '887.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination.'}, {'type': 'SECONDARY', 'title': 'Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'title': 'rSBA-MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '325.5', 'groupId': 'OG000', 'lowerLimit': '243.9', 'upperLimit': '434.5'}]}]}, {'title': 'rSBA-MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '41.2', 'upperLimit': '98'}]}]}, {'title': 'rSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '372.2', 'groupId': 'OG000', 'lowerLimit': '270', 'upperLimit': '513'}]}]}, {'title': 'rSBA-MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '247.6', 'groupId': 'OG000', 'lowerLimit': '190.7', 'upperLimit': '321.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 25-36 months post-vaccination in previous 107137 (NCT00496015) study', 'description': 'The Neisseria meningitidis serogroups assessed using rabbit complement were: A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY), presented as geometric mean titers (GMTs). The seropositivity cut-off of the assay was an antibody titer ≥ 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for antibody persistence, which included all subjects with the vaccine administration documented, for whom assay results were available for antibodies against each considered antigen for the blood sample taken before the administration of Synflorix™ vaccine.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the primed groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'title': 'Any pain, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 pain, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Any redness, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 redness, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Any swelling, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 swelling, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Any pain, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 pain, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Any redness, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 redness, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Any swelling, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 swelling, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Any redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Any swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the unprimed group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.'}], 'classes': [{'title': 'Any drowsiness', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 drowsiness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related drowsiness', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Any loss of appetite', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 loss of appetite', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related loss of appetite', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any fever (Axillary)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 fever (Axillary)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related fever', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the primed groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'title': 'Any drowsiness, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 drowsiness, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related drowsiness, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Related irritability, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Any loss of appetite, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 loss of appetite, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Related loss of appetite, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Any fever (Axillary), D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 fever (Axillary), D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related fever, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Any drowsiness, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 drowsiness, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related drowsiness, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related irritability, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Any loss of appetite, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 loss of appetite, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related loss of appetite, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Any fever (Axillary), D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 fever (Axillary), D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related fever, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Any drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Related drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Related irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Any loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Related loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Any fever (Axillary), Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 fever (Axillary), Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Related fever, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the unprimed group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.'}, {'id': 'OG002', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 31 days (Days 0-30) after each vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.'}, {'id': 'OG002', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Month 10 or Month 12)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': '31-44 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': '40-48 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'Positive cultures of S. pneumoniae Synflorix™ vaccine serotypes identified in the nasopharynx were recorded.', 'unitOfMeasure': 'Swabs associated to specified bacteria', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.'}, {'type': 'SECONDARY', 'title': 'Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': '31-44 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '40-48 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'Positive cultures of S. pneumoniae cross- reactive serotypes identified in the nasopharynx were recorded.', 'unitOfMeasure': 'Swabs associated to specified bacteria', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.'}, {'type': 'SECONDARY', 'title': 'Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': '31-44 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': '40-48 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'Positive cultures of S. pneumoniae non- Synflorix™ vaccine, non-cross-reactive serotypes identified in the nasopharynx were recorded.', 'unitOfMeasure': 'Swabs associated to specified bacteria', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.'}, {'type': 'SECONDARY', 'title': 'Number of Nasopharyngeal Swabs With Haemophilus Influenzae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': '31-44 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': '40-48 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'Positive cultures of H. influenzae identified in the nasopharynx were recorded.', 'unitOfMeasure': 'Swabs associated to specified bacteria', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': '31-44 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '40-48 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'The number of subjects with new acquisition of S. pneumoniae (Synflorix™ vaccine serotypes) detected in nasopharyngeal swabs was recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': '31-44 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '40-48 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'The number of subjects with new acquisition of S. pneumoniae (cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': '31-44 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': '40-48 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'The number of subjects with new acquisition of S. pneumoniae (non-vaccine and non-cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'OG001', 'title': 'Pooled Synflorix I+II Group', 'description': 'For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.'}], 'classes': [{'title': '31-44 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': '40-48 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'The number of subjects with new acquisition of H. influenzae detected in nasopharyngeal swabs was recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.'}, {'id': 'FG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.'}, {'id': 'FG002', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '223'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Out of the 466 subjects enrolled in the study, 5 subjects were not included in the Total effective cohort as they did not meet eligibility criteria. Out of the 461 subjects enrolled in the Total effective cohort, 18 subjects were not included in the Total vaccinated cohort as these subjects withdrew before the first vaccination visit (Visit 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}, {'value': '443', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.'}, {'id': 'BG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.'}, {'id': 'BG002', 'title': 'Synflorix III Group', 'description': 'Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'spread': '1.53', 'groupId': 'BG000'}, {'value': '39.1', 'spread': '1.54', 'groupId': 'BG001'}, {'value': '37.7', 'spread': '3.36', 'groupId': 'BG002'}, {'value': '38.4', 'spread': '2.71', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '236', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White - Caucasian / European heritage', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}, {'value': '433', 'groupId': 'BG003'}]}]}, {'title': 'White - Arabic / North African heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', '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': 466}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'dispFirstSubmitDate': '2010-12-07', 'completionDateStruct': {'date': '2010-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2009-07-30', 'dispFirstSubmitQcDate': '2010-12-07', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2009-07-30', 'dispFirstPostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-25', 'studyFirstPostDateStruct': {'date': '2009-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Concentrations Against Vaccine Pneumococcal Serotypes', 'timeFrame': 'At 7-10 days after the first vaccine dose', 'description': 'Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.'}], 'secondaryOutcomes': [{'measure': 'Antibody Concentrations Against Vaccine Pneumococcal Serotypes', 'timeFrame': 'Prior to the first study vaccine dose (At Day 0)', 'description': 'Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition ELISA, presented as GMCs and expressed in μg/mL. The seropositivity cut-off value of the assay was an antibody concentration ≥ 0.05 μg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).'}, {'measure': 'Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (Opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).'}, {'measure': 'Antibody Concentrations Against Protein D (Anti-PD)', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.'}, {'measure': 'Memory B-cell Detection for Vaccine Polysaccharides (PS)', 'timeFrame': 'Prior to (Day 0) and 7-10 days after the first vaccine dose', 'description': 'B-cell detection for the pneumococcal serotype specific polysaccharides (1, 5, 6B, 18C, 19F, 23F and C) was tabulated for a subset of subjects from each group. The results are expressed as the frequencies of antigen-specific memory B-cells within the total memory B-cell population.'}, {'measure': 'Antibody Concentrations Against Vaccine Pneumococcal Serotypes', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs), expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).'}, {'measure': 'Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).'}, {'measure': 'Antibody Concentrations Against Protein D (Anti-PD)', 'timeFrame': 'At Month 12, one month after the second vaccine dose', 'description': 'Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.'}, {'measure': 'Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men)', 'timeFrame': 'At 25-36 months post-vaccination in previous 107137 (NCT00496015) study', 'description': 'The Neisseria meningitidis serogroups assessed using rabbit complement were: A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY), presented as geometric mean titers (GMTs). The seropositivity cut-off of the assay was an antibody titer ≥ 8.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the primed groups.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the unprimed group.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the primed groups.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the unprimed group.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 31 days (Days 0-30) after each vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period (from Day 0 up to Month 10 or Month 12)', '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 Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes)', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'Positive cultures of S. pneumoniae Synflorix™ vaccine serotypes identified in the nasopharynx were recorded.'}, {'measure': 'Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'Positive cultures of S. pneumoniae cross- reactive serotypes identified in the nasopharynx were recorded.'}, {'measure': 'Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'Positive cultures of S. pneumoniae non- Synflorix™ vaccine, non-cross-reactive serotypes identified in the nasopharynx were recorded.'}, {'measure': 'Number of Nasopharyngeal Swabs With Haemophilus Influenzae', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'Positive cultures of H. influenzae identified in the nasopharynx were recorded.'}, {'measure': 'Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'The number of subjects with new acquisition of S. pneumoniae (Synflorix™ vaccine serotypes) detected in nasopharyngeal swabs was recorded.'}, {'measure': 'Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'The number of subjects with new acquisition of S. pneumoniae (cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.'}, {'measure': 'Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'The number of subjects with new acquisition of S. pneumoniae (non-vaccine and non-cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.'}, {'measure': 'Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs', 'timeFrame': 'At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age', 'description': 'The number of subjects with new acquisition of H. influenzae detected in nasopharyngeal swabs was recorded.'}]}, 'conditionsModule': {'keywords': ['Catch-up vaccination', 'Pneumococcal vaccine', 'Immune memory', 'Nasopharyngeal carriage', 'Immunogenicity', 'Pneumococcal disease', 'Safety'], 'conditions': ['Infections, Streptococcal']}, 'referencesModule': {'availIpds': [{'id': '112801', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112801', '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': '112801', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112801', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112801', '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': '112801', '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': '112801', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '23391599', 'type': 'BACKGROUND', 'citation': 'Prymula R, Habib A, Francois N, Borys D, Schuerman L. Immunological memory and nasopharyngeal carriage in 4-year-old children previously primed and boosted with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with or without concomitant prophylactic paracetamol. Vaccine. 2013 Apr 12;31(16):2080-8. doi: 10.1016/j.vaccine.2013.01.044. Epub 2013 Feb 5.'}, {'type': 'BACKGROUND', 'citation': 'Prymula R et al. Immune memory 2-3 years after vaccination with pneumococcal non-typeable Heamophilus influenzae protein-D conjugate vaccine (PHiD-CV), with or without prophylactic paracetamol. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.'}, {'type': 'BACKGROUND', 'citation': 'Prymula R et al. Long-term effect of 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) on nasopharyngeal bacterial carriage in Czech children. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.'}, {'type': 'BACKGROUND', 'citation': 'Silfverdal SA et al. Immunogenicity and reactogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) during the fourth year of life. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.'}], '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 objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.\n\nThis protocol posting deals with objectives \\& outcome measures of the extension phase. The objectives \\& outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives \\& outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).", 'detailedDescription': 'This protocol posting has been updated according to Protocol Amendment 1, July 2009'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '44 Months', 'minimumAge': '31 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, 31 and 34 months of age at the time of the enrolment.\n* Subjects who previously participated in study NCT00496015\n* For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.\n* For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.\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* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* History of seizures or progressive neurological disease.\n* Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.\n* Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.\n* A family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or serious chronic illness.\n* Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).\n* Administration of any pneumococcal vaccine since the end of study NCT00496015.'}, 'identificationModule': {'nctId': 'NCT00950833', 'briefTitle': 'Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children', 'orgStudyIdInfo': {'id': '112801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AP-AP Group', 'description': 'subjects from the AP-AP group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015, receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment', 'interventionNames': ['Biological: Pneumococcal vaccine GSK1024850A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NAP-pre Group', 'description': 'subjects from the NAP-pre group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015 receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment', 'interventionNames': ['Biological: Pneumococcal vaccine GSK1024850A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unprimed Group', 'description': 'Age-matched subjects from the unprimed group of the NCT00496015 study, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A', 'interventionNames': ['Biological: Pneumococcal vaccine GSK1024850A']}], 'interventions': [{'name': 'Pneumococcal vaccine GSK1024850A', 'type': 'BIOLOGICAL', 'description': '1 or 2 intramuscular injections', 'armGroupLabels': ['AP-AP Group', 'NAP-pre Group', 'Unprimed Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '628 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '500 01', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '377 01', 'city': 'Jindřichův Hradec', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.14404, 'lon': 15.00301}}, {'zip': '547 01', 'city': 'Náchod', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.4167, 'lon': 16.16289}}, {'zip': '70800', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '532 03', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '150 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '160 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '190 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '669 00', 'city': 'Znojmo', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.8555, 'lon': 16.0488}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}