Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-03 @ 2:44 PM
Study NCT ID:
NCT00985751
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2009-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D006192', 'term': 'Haemophilus 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'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial 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 local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).', 'eventGroups': [{'id': 'EG000', 'title': 'GSK 2189242A-LD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).", 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 47, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'GSK 2189242A-HD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).", 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 49, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Synflorix/GSK 2189242A-LD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 49, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Synflorix/GSK 2189242A-HD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 49, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Synflorix Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 49, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain Primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Redness Primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Swelling Primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain Booster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Redness Booster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Swelling Booster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drowsiness Primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Irritability Primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Loss of appetite Primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Temperature/Rectally Primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drowsiness Booster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Irritability Booster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Loss of appetite Booster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Temperature/Rectally Booster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis Primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis Booster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinitis Primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinitis Booster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Accidental exposure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Open wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Adenoidal hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ear haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pharyngo-tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Fever > 40.0°C (Rectal Temperature)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': 'Synflorix/GSK 2189242A Group', 'description': 'This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '5.32', 'groupDescription': "Fever \\>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (GSK 2189242A) combined with Synflorix™ vaccine (pooled groups) versus Synflorix™ vaccine (Synflorix/GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \\> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \\> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the Synflorix/GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \\>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination', 'description': 'The number of subjects with rectal temperature higher (\\>) than 40.0 degrees Celsius (°C) is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Fever > 40.0°C (Rectal Temperature)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': 'GSK 2189242A Group', 'description': 'This group included subjects from GSK 2189242A-LD and GSK 2189242A-HD groups for whom pooled analysis was conducted.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '5.32', 'groupDescription': "Fever \\>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine GSK 2189242A (pooled groups) versus Synflorix™ vaccine (GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \\> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \\> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \\>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be express'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination', 'description': 'The number of subjects with rectal temperature higher (\\>) than 40.0 degrees Celsius (°C) is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 2189242A-LD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG001', 'title': 'GSK 2189242A-HD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG002', 'title': 'Synflorix/GSK 2189242A-LD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Synflorix/GSK 2189242A-HD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG004', 'title': 'Synflorix Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'Any Pain Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Any Pain Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any Pain Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 2189242A-LD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG001', 'title': 'GSK 2189242A-HD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG002', 'title': 'Synflorix/GSK 2189242A-LD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Synflorix/GSK 2189242A-HD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG004', 'title': 'Synflorix Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'Any Drowsiness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Drowsiness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Drowsiness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Any Irritability Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, 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'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 2189242A-LD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG001', 'title': 'GSK 2189242A-HD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG002', 'title': 'Synflorix/GSK 2189242A-LD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Synflorix/GSK 2189242A-HD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG004', 'title': 'Synflorix Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day (Days 0-30) follow-up period after each primary dose', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 2189242A-LD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG001', 'title': 'GSK 2189242A-HD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG002', 'title': 'Synflorix/GSK 2189242A-LD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. 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The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG001', 'title': 'GSK 2189242A-HD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'OG002', 'title': 'Synflorix/GSK 2189242A-LD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Synflorix/GSK 2189242A-HD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'OG004', 'title': 'Synflorix Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'OPSONO-1, Post-Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '7.8'}, {'value': '71.8', 'groupId': 'OG002', 'lowerLimit': '40.9', 'upperLimit': '126.1'}, {'value': '48.2', 'groupId': 'OG003', 'lowerLimit': '26.5', 'upperLimit': '87.6'}, {'value': '90', 'groupId': 'OG004', 'lowerLimit': '52.9', 'upperLimit': '153'}]}]}, {'title': 'OPSONO-1, Pre-booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, 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'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '6.7'}, {'value': '99.3', 'groupId': 'OG002', 'lowerLimit': '62.1', 'upperLimit': '158.8'}, {'value': '110.4', 'groupId': 'OG003', 'lowerLimit': '73.1', 'upperLimit': '166.8'}, {'value': '160.7', 'groupId': 'OG004', 'lowerLimit': '113', 'upperLimit': '228.7'}]}]}, {'title': 'OPSONO-6B, Post-Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': 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'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '734.6', 'groupId': 'OG000', 'lowerLimit': '369.7', 'upperLimit': '1459.6'}, {'value': '807.4', 'groupId': 'OG001', 'lowerLimit': '445', 'upperLimit': '1465.2'}, {'value': '5703.7', 'groupId': 'OG002', 'lowerLimit': '4143.6', 'upperLimit': '7851.2'}, {'value': '4936.6', 'groupId': 'OG003', 'lowerLimit': '3320.7', 'upperLimit': '7338.7'}, {'value': '6154.4', 'groupId': 'OG004', 'lowerLimit': '4244.4', 'upperLimit': '8923.7'}]}]}, {'title': 'OPSONO-7F, Pre-booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '670.4', 'groupId': 'OG000', 'lowerLimit': '317.5', 'upperLimit': '1415.6'}, {'value': '462.3', 'groupId': 'OG001', 'lowerLimit': '187.5', 'upperLimit': '1139.8'}, {'value': '2450.1', 'groupId': 'OG002', 'lowerLimit': '1637.4', 'upperLimit': '3666.2'}, {'value': '2713.5', 'groupId': 'OG003', 'lowerLimit': '1836.1', 'upperLimit': '4010.1'}, {'value': '3844.5', 'groupId': 'OG004', 'lowerLimit': '2725.7', 'upperLimit': '5422.4'}]}]}, {'title': 'OPSONO-7F, Post-booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '936.8', 'groupId': 'OG000', 'lowerLimit': '510', 'upperLimit': '1720.7'}, {'value': '785.5', 'groupId': 'OG001', 'lowerLimit': '428', 'upperLimit': '1441.6'}, {'value': '4109.3', 'groupId': 'OG002', 'lowerLimit': '3086.9', 'upperLimit': '5470.3'}, {'value': '5730.4', 'groupId': 'OG003', 'lowerLimit': '4262', 'upperLimit': 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'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '90.9'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '127.8'}, {'value': '2911.6', 'groupId': 'OG002', 'lowerLimit': '1841.3', 'upperLimit': '4604'}, {'value': '3729.8', 'groupId': 'OG003', 'lowerLimit': '2693.2', 'upperLimit': '5165.4'}, {'value': '3094', 'groupId': 'OG004', 'lowerLimit': '2353.3', 'upperLimit': '4068'}]}]}, {'title': 'OPSONO-18C, Post-Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '15.1'}, {'value': '1398.3', 'groupId': 'OG002', 'lowerLimit': '810.6', 'upperLimit': '2412'}, {'value': '2538.4', 'groupId': 'OG003', 'lowerLimit': '1787.3', 'upperLimit': '3605'}, {'value': '1905.4', 'groupId': 'OG004', 'lowerLimit': '1271.4', 'upperLimit': '2855.6'}]}]}, {'title': 'OPSONO-18C, Pre-booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '8.3'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '6.8'}, {'value': '420.1', 'groupId': 'OG002', 'lowerLimit': '192.8', 'upperLimit': '915.3'}, {'value': '1041', 'groupId': 'OG003', 'lowerLimit': '699.6', 'upperLimit': '1548.9'}, {'value': '766.4', 'groupId': 'OG004', 'lowerLimit': '468.4', 'upperLimit': 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The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'FG001', 'title': 'GSK 2189242A-HD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'FG002', 'title': 'Synflorix/GSK 2189242A-LD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'FG003', 'title': 'Synflorix/GSK 2189242A-HD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'FG004', 'title': 'Synflorix Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '257', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK 2189242A-LD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'BG001', 'title': 'GSK 2189242A-HD Group', 'description': "Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate)."}, {'id': 'BG002', 'title': 'Synflorix/GSK 2189242A-LD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'BG003', 'title': 'Synflorix/GSK 2189242A-HD Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'BG004', 'title': 'Synflorix Group', 'description': 'Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '16.7', 'spread': '3.81', 'groupId': 'BG001'}, {'value': '17.1', 'spread': '4.03', 'groupId': 'BG002'}, {'value': '16.8', 'spread': '3.96', 'groupId': 'BG003'}, {'value': '16.3', 'spread': '4.18', 'groupId': 'BG004'}, {'value': '16.78', 'spread': '3.90', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '127', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '130', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White-Caucasian/European heritage', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '254', 'groupId': 'BG005'}]}]}, {'title': 'White-Arabic/North African heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2011-04-01', 'completionDateStruct': {'date': '2011-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2009-09-24', 'dispFirstSubmitQcDate': '2011-04-01', 'resultsFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2009-09-24', 'dispFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-11', 'studyFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Fever > 40.0°C (Rectal Temperature)', 'timeFrame': 'Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination', 'description': 'The number of subjects with rectal temperature higher (\\>) than 40.0 degrees Celsius (°C) is reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 31-day (Days 0-30) follow-up period after each primary dose', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 31-day (Days 0-30) follow-up period after the booster dose', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)', 'description': 'SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations', 'timeFrame': 'One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)', 'description': 'Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.'}, {'measure': 'Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations', 'timeFrame': 'One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)', 'description': 'Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes', 'timeFrame': 'One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)', 'description': 'Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.'}, {'measure': 'Antibody Concentrations to Protein D (Anti-PD)', 'timeFrame': 'One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)', 'description': 'Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).'}, {'measure': 'Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity', 'timeFrame': 'One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)', 'description': 'Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.'}]}, 'conditionsModule': {'keywords': ['immunogenicity', 'toddlers', 'Pneumococcal vaccine', 'Haemophilus influenzae', 'safety', 'Streptococcus pneumoniae', 'Streptococcus Pneumoniae Vaccines'], 'conditions': ['Infections, Streptococcal']}, 'referencesModule': {'availIpds': [{'id': '113171', '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': '113171', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113171', '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': '113171', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113171', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '24699466', 'type': 'BACKGROUND', 'citation': 'Prymula R, Pazdiora P, Traskine M, Ruggeberg JU, Borys D. Safety and immunogenicity of an investigational vaccine containing two common pneumococcal proteins in toddlers: a phase II randomized clinical trial. Vaccine. 2014 May 23;32(25):3025-34. doi: 10.1016/j.vaccine.2014.03.066. Epub 2014 Apr 1.'}], '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': "This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature \\>40.0°C)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol\n* Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.\n* Written informed consent obtained from the parents/LAR(s) of the subject.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.\n* Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).\n* Previous vaccination against S. pneumoniae since birth.\n* History of any hypersensitivity reaction following any previous vaccination.\n* Eczema and any history of allergy\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.\n* A family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or any chronic illness.\n* History of any neurologic disorders or seizures.\n* Acute disease and/or fever at the time of enrolment.\n* Fever is defined as temperature \\>= 37.5°C on oral or axillary setting, or \\>= 38.0°C on rectal setting.\n* Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.\n* Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.\n* Child in care.'}, 'identificationModule': {'nctId': 'NCT00985751', 'briefTitle': 'Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Children Aged 12-23 Months at the Time of First Vaccination.", 'orgStudyIdInfo': {'id': '113171'}, 'secondaryIdInfos': [{'id': '2009-012701-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Biological: Pneumococcal vaccine GSK2189242A (formulation 1)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Biological: Pneumococcal vaccine GSK2189242A (formulation 2)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'interventionNames': ['Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'interventionNames': ['Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'interventionNames': ['Biological: Pneumococcal vaccine GSK1024850A']}], 'interventions': [{'name': 'Pneumococcal vaccine GSK2189242A (formulation 1)', 'type': 'BIOLOGICAL', 'description': 'Three doses will be administered intramuscularly, at Month 0, 2 and 6.', 'armGroupLabels': ['Group 1']}, {'name': 'Pneumococcal vaccine GSK2189242A (formulation 2)', 'type': 'BIOLOGICAL', 'description': 'Three doses will be administered intramuscularly, at Month 0, 2 and 6', 'armGroupLabels': ['Group 2']}, {'name': 'Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)', 'type': 'BIOLOGICAL', 'description': 'Three doses will be administered intramuscularly, at Month 0, 2 and 6', 'armGroupLabels': ['Group 3']}, {'name': 'Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)', 'type': 'BIOLOGICAL', 'description': 'Three doses will be administered intramuscularly, at Month 0, 2 and 6', 'armGroupLabels': ['Group 4']}, {'name': 'Pneumococcal vaccine GSK1024850A', 'type': 'BIOLOGICAL', 'description': 'Three doses will be administered intramuscularly, at Month 0, 2 and 6', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43003', 'city': 'Chomutov', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.46048, 'lon': 13.41779}}, {'zip': '405 01', 'city': 'Děčín', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.78215, 'lon': 14.21478}}, {'zip': '547 01', 'city': 'Náchod', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.4167, 'lon': 16.16289}}, {'zip': '25070', 'city': 'Odolena Voda', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.23341, 'lon': 14.41078}}, {'zip': '70868', 'city': 'Ostrava - Poruba', 'country': 'Czechia', 'facility': 'GSK Investigational Site'}, {'zip': '532 03', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '305 99', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '140 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '1600', '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': {'url': 'https://www.clinicalstudydatarequest.com/Posting.aspx?ID=4501', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}