Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2026-06-17 @ 7:46 PM
Study NCT ID:
NCT02207816
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2014-07-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'C000719547', 'term': 'RTS malaria vaccine'}, {'id': 'C410218', 'term': 'serogroup C meningococcal conjugate vaccine'}, {'id': 'C023768', 'term': 'halofantrine'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cc781166@gsk.com', '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': 'Serious Adverse Events (SAEs): during the entire follow-up period, from Year 0 to Year 3 (Starting January 2014 and ending December 2016).', 'description': 'Safety results include data for subjects who had a signed ICF for study Malaria-076 by the parent(s)/LAR(s), including SAE data from subjects who were not enrolled in study Malaria-076 but had a reason for non-participation (death) collected. Solicited and unsolicited AE(s) were not collected during this study.', 'eventGroups': [{'id': 'EG000', 'title': 'GSK257049 Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1051, 'otherNumAffected': 0, 'seriousNumAtRisk': 1051, 'deathsNumAffected': 5, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'GSK257049 Comparator Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1015, 'otherNumAffected': 0, 'seriousNumAtRisk': 1015, 'deathsNumAffected': 10, 'seriousNumAffected': 43}, {'id': 'EG002', 'title': 'VeroRab/Menjugate Comparator Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1033, 'otherNumAffected': 0, 'seriousNumAtRisk': 1033, 'deathsNumAffected': 7, 'seriousNumAffected': 52}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sickle cell anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 56, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Meningitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Meningitis meningococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Typhoid fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hemiplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1015, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Severe Malaria Meeting Case Definition 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '456', 'groupId': 'OG004'}, {'value': '442', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.001', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}, {'value': '0.002', 'groupId': 'OG002'}, {'value': '0.004', 'groupId': 'OG003'}, {'value': '0.003', 'groupId': 'OG004'}, {'value': '0.005', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.2235', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.38', 'ciLowerLimit': '-130', 'ciUpperLimit': '97.14', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.8972', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.57', 'ciLowerLimit': '-339', 'ciUpperLimit': '72.64', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.5333', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.58', 'ciLowerLimit': '-119', 'ciUpperLimit': '78.00', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.3523', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.20', 'ciLowerLimit': '-90.9', 'ciUpperLimit': '83.69', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}], 'paramType': 'NUMBER', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \\< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).', 'unitOfMeasure': 'events per person-year', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding study vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'PRIMARY', 'title': 'Incidence of Severe Malaria Meeting Case Definition 2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '456', 'groupId': 'OG004'}, {'value': '442', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.004', 'groupId': 'OG000'}, {'value': '0.007', 'groupId': 'OG001'}, {'value': '0.009', 'groupId': 'OG002'}, {'value': '0.007', 'groupId': 'OG003'}, {'value': '0.007', 'groupId': 'OG004'}, {'value': '0.011', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0930', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.68', 'ciLowerLimit': '-13.7', 'ciUpperLimit': '81.13', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.5035', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.33', 'ciLowerLimit': '-67.1', 'ciUpperLimit': '64.82', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.3504', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.08', 'ciLowerLimit': '-53.1', 'ciUpperLimit': '69.87', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.2704', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.57', 'ciLowerLimit': '-44.4', 'ciUpperLimit': '73.01', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}], 'paramType': 'NUMBER', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \\< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).', 'unitOfMeasure': 'events per person-year', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Incidence of Clinical Malaria Meeting Case Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '456', 'groupId': 'OG004'}, {'value': '442', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.079', 'groupId': 'OG000'}, {'value': '1.108', 'groupId': 'OG001'}, {'value': '1.016', 'groupId': 'OG002'}, {'value': '1.632', 'groupId': 'OG003'}, {'value': '1.563', 'groupId': 'OG004'}, {'value': '1.686', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.4434', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.26', 'ciLowerLimit': '-20.0', 'ciUpperLimit': '7.69', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model with over-dispersion parameter estimated from the random effect \\[Lievens, 2011\\].'}, {'pValue': '0.2634', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.10', 'ciLowerLimit': '-23.9', 'ciUpperLimit': '5.70', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model with over-dispersion parameter estimated from the random effect \\[Lievens, 2011\\].'}, {'pValue': '0.9278', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '-13.7', 'ciUpperLimit': '13.13', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model with over-dispersion parameter estimated from the random effect \\[Lievens, 2011\\].'}, {'pValue': '0.4189', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.32', 'ciLowerLimit': '-8.12', 'ciUpperLimit': '17.09', 'groupDescription': 'Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model with over-dispersion parameter estimated from the random effect \\[Lievens, 2011\\].'}], 'paramType': 'NUMBER', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.', 'unitOfMeasure': 'events per person-year', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '456', 'groupId': 'OG004'}, {'value': '442', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.1302', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.10', 'ciLowerLimit': '-32.2', 'ciUpperLimit': '82.90', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6897', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.90', 'ciLowerLimit': '-96.9', 'ciUpperLimit': '65.90', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5299', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.90', 'ciLowerLimit': '-82.9', 'ciUpperLimit': '70.90', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5307', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.40', 'ciLowerLimit': '-84.1', 'ciUpperLimit': '70.70', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '456', 'groupId': 'OG004'}, {'value': '442', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.1853', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.20', 'ciLowerLimit': '-45.0', 'ciUpperLimit': '81.80', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3828', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.00', 'ciLowerLimit': '-69.3', 'ciUpperLimit': '76.60', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4112', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.20', 'ciLowerLimit': '-66.5', 'ciUpperLimit': '72.70', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4121', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.80', 'ciLowerLimit': '-67.6', 'ciUpperLimit': '72.50', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Prevalent Parasitemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '561', 'groupId': 'OG002'}, {'value': '436', 'groupId': 'OG003'}, {'value': '435', 'groupId': 'OG004'}, {'value': '420', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'title': 'Prevalent parasitemia, Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '176', 'groupId': 'OG004'}, {'value': '169', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}]}, {'title': 'Prevalent parasitemia, Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '561', 'groupId': 'OG002'}, {'value': '436', 'groupId': 'OG003'}, {'value': '435', 'groupId': 'OG004'}, {'value': '420', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}, {'value': '123', 'groupId': 'OG005'}]}]}, {'title': 'Prevalent parasitemia, Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}, {'value': '549', 'groupId': 'OG002'}, {'value': '434', 'groupId': 'OG003'}, {'value': '408', 'groupId': 'OG004'}, {'value': '411', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.80', 'ciLowerLimit': '15.70', 'ciUpperLimit': '58.80', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine effiicacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.70', 'ciLowerLimit': '17.40', 'ciUpperLimit': '60.80', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0883', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.00', 'ciLowerLimit': '-6.60', 'ciUpperLimit': '33.90', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1889', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.00', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '31.70', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0770', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.40', 'ciLowerLimit': '-5.90', 'ciUpperLimit': '34.00', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-25.8', 'ciUpperLimit': '20.70', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1624', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.80', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '46.90', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9112', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.30', 'ciLowerLimit': '-47.6', 'ciUpperLimit': '29.00', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4023', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.20', 'ciLowerLimit': '-18.0', 'ciUpperLimit': '30.10', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7091', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.40', 'ciLowerLimit': '-34.5', 'ciUpperLimit': '18.90', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9361', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.40', 'ciLowerLimit': '-34.7', 'ciUpperLimit': '23.60', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6280', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.80', 'ciLowerLimit': '-42.0', 'ciUpperLimit': '19.60', 'groupDescription': 'Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Years 1, 2 and 3', 'description': 'Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (\\>) 0 parasites/µL, identified at an annual visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '562', 'groupId': 'OG002'}, {'value': '437', 'groupId': 'OG003'}, {'value': '436', 'groupId': 'OG004'}, {'value': '421', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'title': 'Prevalent severe anemia, Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '176', 'groupId': 'OG004'}, {'value': '169', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Prevalent severe anemia, Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '562', 'groupId': 'OG002'}, {'value': '437', 'groupId': 'OG003'}, {'value': '436', 'groupId': 'OG004'}, {'value': '421', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Prevalent severe anemia, Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}, {'value': '550', 'groupId': 'OG002'}, {'value': '434', 'groupId': 'OG003'}, {'value': '408', 'groupId': 'OG004'}, {'value': '411', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.4987', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.0', 'ciLowerLimit': '-3779', 'ciUpperLimit': '100.0', 'groupDescription': 'Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '-4051', 'ciUpperLimit': '100.0', 'groupDescription': 'Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Years 1, 2 and 3', 'description': 'Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (\\<) 5.0 grams per deciliter (g/dL), identified at an annual visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '562', 'groupId': 'OG002'}, {'value': '437', 'groupId': 'OG003'}, {'value': '436', 'groupId': 'OG004'}, {'value': '421', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'title': 'Prevalent moderate anemia, Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '176', 'groupId': 'OG004'}, {'value': '169', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}, {'title': 'Prevalent moderate anemia, Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '562', 'groupId': 'OG002'}, {'value': '437', 'groupId': 'OG003'}, {'value': '436', 'groupId': 'OG004'}, {'value': '421', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Prevalent moderate anemia, Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}, {'value': '550', 'groupId': 'OG002'}, {'value': '434', 'groupId': 'OG003'}, {'value': '408', 'groupId': 'OG004'}, {'value': '411', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.1025', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-254.60', 'ciLowerLimit': '-3399', 'ciUpperLimit': '32.50', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0284', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-398.60', 'ciLowerLimit': '-4642', 'ciUpperLimit': '-3.20', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3543', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.70', 'ciLowerLimit': '-78.8', 'ciUpperLimit': '79.20', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.20', 'ciLowerLimit': '-151', 'ciUpperLimit': '63.20', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3809', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.00', 'ciLowerLimit': '-120', 'ciUpperLimit': '88.00', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5490', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.10', 'ciLowerLimit': '-140', 'ciUpperLimit': '86.90', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3239', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.30', 'ciLowerLimit': '-249', 'ciUpperLimit': '36.20', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2184', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.60', 'ciLowerLimit': '-54.5', 'ciUpperLimit': '84.10', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0724', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-116.80', 'ciLowerLimit': '-476', 'ciUpperLimit': '10.30', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2055', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-81.00', 'ciLowerLimit': '-393', 'ciUpperLimit': '27.90', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8138', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.40', 'ciLowerLimit': '-245', 'ciUpperLimit': '57.90', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7887', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.40', 'ciLowerLimit': '-148', 'ciUpperLimit': '78.40', 'groupDescription': 'Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Years 1, 2 and 3', 'description': 'Prevalent moderate anemia (PMA) was defined as a documented hemoglobin \\< 8.0 g/dL, identified at an annual visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Incidence of Severe Malaria Meeting Case Definition 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}, {'value': '839', 'groupId': 'OG002'}, {'value': '637', 'groupId': 'OG003'}, {'value': '635', 'groupId': 'OG004'}, {'value': '633', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.009', 'groupId': 'OG000'}, {'value': '0.016', 'groupId': 'OG001'}, {'value': '0.015', 'groupId': 'OG002'}, {'value': '0.014', 'groupId': 'OG003'}, {'value': '0.013', 'groupId': 'OG004'}, {'value': '0.02', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0077', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.50', 'ciLowerLimit': '12.84', 'ciUpperLimit': '59.39', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.7922', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.52', 'ciLowerLimit': '-45.3', 'ciUpperLimit': '24.80', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.0802', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.03', 'ciLowerLimit': '-4.22', 'ciUpperLimit': '51.67', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.0387', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.87', 'ciLowerLimit': '2.13', 'ciUpperLimit': '55.32', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)', 'description': 'Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \\< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).', 'unitOfMeasure': 'events per person-year', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.'}, {'type': 'SECONDARY', 'title': 'Incidence of Severe Malaria Meeting Case Definition 2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}, {'value': '839', 'groupId': 'OG002'}, {'value': '637', 'groupId': 'OG003'}, {'value': '635', 'groupId': 'OG004'}, {'value': '633', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.015', 'groupId': 'OG000'}, {'value': '0.021', 'groupId': 'OG001'}, {'value': '0.023', 'groupId': 'OG002'}, {'value': '0.019', 'groupId': 'OG003'}, {'value': '0.019', 'groupId': 'OG004'}, {'value': '0.028', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.69', 'ciLowerLimit': '14.60', 'ciUpperLimit': '53.07', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.4430', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.14', 'ciLowerLimit': '-18.1', 'ciUpperLimit': '31.64', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.0245', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.99', 'ciLowerLimit': '4.67', 'ciUpperLimit': '50.04', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}, {'pValue': '0.0122', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.24', 'ciLowerLimit': '8.74', 'ciUpperLimit': '52.61', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model without random effect \\[Lievens, 2011\\].'}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)', 'description': 'Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \\< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).', 'unitOfMeasure': 'events per person-year', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.'}, {'type': 'SECONDARY', 'title': 'Incidence of Clinical Malaria Meeting Case Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}, {'value': '839', 'groupId': 'OG002'}, {'value': '637', 'groupId': 'OG003'}, {'value': '635', 'groupId': 'OG004'}, {'value': '633', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.277', 'groupId': 'OG000'}, {'value': '1.348', 'groupId': 'OG001'}, {'value': '1.555', 'groupId': 'OG002'}, {'value': '1.662', 'groupId': 'OG003'}, {'value': '1.723', 'groupId': 'OG004'}, {'value': '1.921', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.67', 'ciLowerLimit': '15.93', 'ciUpperLimit': '30.71', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model with over-dispersion parameter estimated from the random effect \\[Lievens, 2011\\].'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.15', 'ciLowerLimit': '10.81', 'ciUpperLimit': '26.71', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[5-17M\\] Group over the total number of events/follow-up time in the VeroRab Comparator \\[5-17M\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model with over-dispersion parameter estimated from the random effect \\[Lievens, 2011\\].'}, {'pValue': '0.0009', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.55', 'ciLowerLimit': '6.72', 'ciUpperLimit': '23.54', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model with over-dispersion parameter estimated from the random effect \\[Lievens, 2011\\].'}, {'pValue': '0.0056', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.15', 'ciLowerLimit': '4.05', 'ciUpperLimit': '21.39', 'groupDescription': 'Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \\[6-12W\\] Group over the total number of events/follow-up time in the Menjugate Comparator \\[6-12W\\] Group).', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model with over-dispersion parameter estimated from the random effect \\[Lievens, 2011\\].'}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)', 'description': 'Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.', 'unitOfMeasure': 'events per subject-year', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}, {'value': '839', 'groupId': 'OG002'}, {'value': '637', 'groupId': 'OG003'}, {'value': '635', 'groupId': 'OG004'}, {'value': '633', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0053', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.50', 'ciLowerLimit': '10.00', 'ciUpperLimit': '54.00', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4255', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.70', 'ciLowerLimit': '-20.0', 'ciUpperLimit': '35.20', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0479', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.20', 'ciLowerLimit': '-2.40', 'ciUpperLimit': '51.40', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2346', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.10', 'ciLowerLimit': '-16.9', 'ciUpperLimit': '42.80', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)', 'description': 'Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}, {'value': '839', 'groupId': 'OG002'}, {'value': '637', 'groupId': 'OG003'}, {'value': '635', 'groupId': 'OG004'}, {'value': '633', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '75', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0051', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.90', 'ciLowerLimit': '10.30', 'ciUpperLimit': '54.40', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3340', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.00', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '37.10', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0511', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.50', 'ciLowerLimit': '-2.90', 'ciUpperLimit': '50.50', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Meenjugate Comparator \\[6-12W\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1729', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.30', 'ciLowerLimit': '-13.5', 'ciUpperLimit': '44.20', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Meenjugate Comparator \\[6-12W\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'description': 'Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '456', 'groupId': 'OG004'}, {'value': '442', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': "Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Fatal Malaria Meeting Case Definition 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '456', 'groupId': 'OG004'}, {'value': '442', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': "Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Fatal Malaria Meeting Case Definition 2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '456', 'groupId': 'OG004'}, {'value': '442', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.6244', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.10', 'ciLowerLimit': '-859', 'ciUpperLimit': '99.20', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.70', 'ciLowerLimit': '-1358', 'ciUpperLimit': '92.30', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6244', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-188.90', 'ciLowerLimit': '-15000', 'ciUpperLimit': '76.80', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.10', 'ciLowerLimit': '-7509', 'ciUpperLimit': '98.80', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group) over the entire follow-up period (from Year 0 to Year 3).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': "Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Cerebral Malaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}, {'value': '839', 'groupId': 'OG002'}, {'value': '637', 'groupId': 'OG003'}, {'value': '635', 'groupId': 'OG004'}, {'value': '633', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.6869', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-98.80', 'ciLowerLimit': '-2098', 'ciUpperLimit': '71.50', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0213', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-406.00', 'ciLowerLimit': '-4650', 'ciUpperLimit': '-7.80', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'description': "Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Fatal Malaria Meeting Case Definition 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}, {'value': '839', 'groupId': 'OG002'}, {'value': '637', 'groupId': 'OG003'}, {'value': '635', 'groupId': 'OG004'}, {'value': '633', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-98.80', 'ciLowerLimit': '-12000', 'ciUpperLimit': '89.60', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2154', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-304.80', 'ciLowerLimit': '-20000', 'ciUpperLimit': '59.90', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'description': "Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Fatal Malaria Meeting Case Definition 2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}, {'value': '839', 'groupId': 'OG002'}, {'value': '637', 'groupId': 'OG003'}, {'value': '635', 'groupId': 'OG004'}, {'value': '633', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.30', 'ciLowerLimit': '-526', 'ciUpperLimit': '73.30', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3834', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-77.10', 'ciLowerLimit': '-725', 'ciUpperLimit': '55.00', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[5-17M\\] Group over the proportion in VeroRab Comparator \\[5-17M\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3740', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-297.50', 'ciLowerLimit': '-19000', 'ciUpperLimit': '60.70', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1240', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-498.10', 'ciLowerLimit': '-27000', 'ciUpperLimit': '27.40', 'groupDescription': 'Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \\[6-12W\\] Group over the proportion in Menjugate Comparator \\[6-12W\\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'statisticalMethod': 'Two-sided Fisher Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'description': "Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '457', 'groupId': 'OG003'}, {'value': '455', 'groupId': 'OG004'}, {'value': '440', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'title': 'Any SAE(s)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}]}, {'title': 'Related SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Malaria SAE(s)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}]}, {'title': 'Fatal SAE(s)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as \'malaria\', \'Plasmodium falciparum infection\' or \'cerebral malaria". A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '457', 'groupId': 'OG003'}, {'value': '455', 'groupId': 'OG004'}, {'value': '440', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Meningitis SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}, {'value': '457', 'groupId': 'OG003'}, {'value': '455', 'groupId': 'OG004'}, {'value': '440', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'title': 'Meningitis meningococcal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Meningitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Meningitis bacterial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': "For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '153', 'groupId': 'OG004'}, {'value': '129', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG001', 'title': 'GSK257049 Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG002', 'title': 'VeroRab Comparator [5-17M] Group', 'description': 'Male or female children between and including 5 to 17 months of age \\[5-17M\\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.'}, {'id': 'OG003', 'title': 'GSK257049 [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG004', 'title': 'GSK257049 Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}, {'id': 'OG005', 'title': 'Menjugate Comparator [6-12W] Group', 'description': 'Male or female infants between and including 6 to 12 weeks of age \\[6-12W\\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.'}], 'classes': [{'title': 'At Month 3 of Malaria-055', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '153', 'groupId': 'OG004'}, {'value': '129', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '671.8', 'groupId': 'OG000', 'lowerLimit': '601.1', 'upperLimit': '750.7'}, {'value': '599.3', 'groupId': 'OG001', 'lowerLimit': '534.0', 'upperLimit': '672.5'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '0.3'}, {'value': '152.9', 'groupId': 'OG003', 'lowerLimit': '121.4', 'upperLimit': '192.4'}, {'value': '169.0', 'groupId': 'OG004', 'lowerLimit': '135.9', 'upperLimit': '210.0'}, {'value': '0.3', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '0.3'}]}]}, {'title': 'At Month 20 of Malaria-055', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '144', 'groupId': 'OG004'}, {'value': '128', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '46.5'}, {'value': '40.3', 'groupId': 'OG001', 'lowerLimit': '33.8', 'upperLimit': '48.2'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.3'}, {'value': '4.2', 'groupId': 'OG003', 'lowerLimit': '3.2', 'upperLimit': '5.6'}, {'value': '5.5', 'groupId': 'OG004', 'lowerLimit': '4.2', 'upperLimit': '7.2'}, {'value': '0.3', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '0.3'}]}]}, {'title': 'At Month 21 of Malaria-055', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '126', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '368.6', 'groupId': 'OG000', 'lowerLimit': '329.1', 'upperLimit': '412.9'}, {'value': '38.8', 'groupId': 'OG001', 'lowerLimit': '32.5', 'upperLimit': '46.2'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.3'}, {'value': '149.3', 'groupId': 'OG003', 'lowerLimit': '119.4', 'upperLimit': '186.6'}, {'value': '5.3', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '6.9'}, {'value': '0.3', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '0.4'}]}]}, {'title': 'At Month 32 of Malaria-055', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}, {'value': '142', 'groupId': 'OG004'}, {'value': '125', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '63.3'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '17.6', 'upperLimit': '25.2'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.3'}, {'value': '11.7', 'groupId': 'OG003', 'lowerLimit': '8.6', 'upperLimit': '16.0'}, {'value': '3.6', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '4.6'}, {'value': '0.4', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '0.4'}]}]}, {'title': 'At Year 1 of Malaria-076', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '27.5'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '18.5'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.5'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '3.8', 'upperLimit': '9.1'}, {'value': '2.5', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '3.2'}, {'value': '1.4', 'groupId': 'OG005', 'lowerLimit': '1.1', 'upperLimit': '1.7'}]}]}, {'title': 'At Year 2 of Malaria-076', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '130', 'groupId': 'OG004'}, {'value': '127', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '17.6'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '8.2'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '1.4'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '6.8'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '2.9'}, {'value': '1.2', 'groupId': 'OG005', 'lowerLimit': '1.1', 'upperLimit': '1.3'}]}]}, {'title': 'At Year 3 of Malaria-076', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}, {'value': '127', 'groupId': 'OG004'}, {'value': '124', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '13.4'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '6.0'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '1.4'}, {'value': '3.9', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '4.9'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '2.6'}, {'value': '1.2', 'groupId': 'OG005', 'lowerLimit': '1.1', 'upperLimit': '1.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)', 'description': 'Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK257049 Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.'}, {'id': 'FG001', 'title': 'GSK257049 Comparator Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.'}, {'id': 'FG002', 'title': 'VeroRab/Menjugate Comparator Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1046'}, {'groupId': 'FG001', 'numSubjects': '1010'}, {'groupId': 'FG002', 'numSubjects': '1028'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '995'}, {'groupId': 'FG001', 'numSubjects': '924'}, {'groupId': 'FG002', 'numSubjects': '961'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '67'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Eligibility Criteria Not Fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Migrated/Moved From Study Area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The randomization that was performed in the primary study NCT00866619 was kept for this extension, in which subjects from 3 sites were enrolled. Subjects remained in the same groups as the ones of the primary study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1046', 'groupId': 'BG000'}, {'value': '1010', 'groupId': 'BG001'}, {'value': '1028', 'groupId': 'BG002'}, {'value': '3084', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK257049 Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.'}, {'id': 'BG001', 'title': 'GSK257049 Comparator Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.'}, {'id': 'BG002', 'title': 'VeroRab/Menjugate Comparator Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.25', 'spread': '0.99', 'groupId': 'BG000'}, {'value': '5.23', 'spread': '0.99', 'groupId': 'BG001'}, {'value': '5.26', 'spread': '0.97', 'groupId': 'BG002'}, {'value': '5.25', 'spread': '0.98', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '517', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '515', 'groupId': 'BG002'}, {'value': '1512', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '529', 'groupId': 'BG000'}, {'value': '530', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}, {'value': '1572', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African Heritage/African American', 'categories': [{'measurements': [{'value': '1046', 'groupId': 'BG000'}, {'value': '1010', 'groupId': 'BG001'}, {'value': '1028', 'groupId': 'BG002'}, {'value': '3084', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-15', 'size': 2471742, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-01-29T03:25', 'hasProtocol': True}, {'date': '2015-10-12', 'size': 3188027, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-29T03:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3084}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2014-07-31', 'resultsFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2014-07-31', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-04', 'studyFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Severe Malaria Meeting Case Definition 1', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \\< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).'}, {'measure': 'Incidence of Severe Malaria Meeting Case Definition 2.', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \\< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).'}], 'secondaryOutcomes': [{'measure': 'Incidence of Clinical Malaria Meeting Case Definition', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.'}, {'measure': 'Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).'}, {'measure': 'Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.'}, {'measure': 'Number of Subjects With Prevalent Parasitemia', 'timeFrame': 'At Years 1, 2 and 3', 'description': 'Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (\\>) 0 parasites/µL, identified at an annual visit.'}, {'measure': 'Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL)', 'timeFrame': 'At Years 1, 2 and 3', 'description': 'Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (\\<) 5.0 grams per deciliter (g/dL), identified at an annual visit.'}, {'measure': 'Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL)', 'timeFrame': 'At Years 1, 2 and 3', 'description': 'Prevalent moderate anemia (PMA) was defined as a documented hemoglobin \\< 8.0 g/dL, identified at an annual visit.'}, {'measure': 'Incidence of Severe Malaria Meeting Case Definition 1.', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)', 'description': 'Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \\< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).'}, {'measure': 'Incidence of Severe Malaria Meeting Case Definition 2.', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)', 'description': 'Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \\< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).'}, {'measure': 'Incidence of Clinical Malaria Meeting Case Definition', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)', 'description': 'Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.'}, {'measure': 'Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)', 'description': 'Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).'}, {'measure': 'Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'description': 'Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.'}, {'measure': 'Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': "Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term."}, {'measure': 'Number of Subjects With Fatal Malaria Meeting Case Definition 1.', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': "Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma)."}, {'measure': 'Number of Subjects With Fatal Malaria Meeting Case Definition 2.', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': "Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome."}, {'measure': 'Number of Subjects With Cerebral Malaria', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'description': "Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term."}, {'measure': 'Number of Subjects With Fatal Malaria Meeting Case Definition 1.', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'description': "Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma)."}, {'measure': 'Number of Subjects With Fatal Malaria Meeting Case Definition 2.', 'timeFrame': 'From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).', 'description': "Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome."}, {'measure': 'Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as \'malaria\', \'Plasmodium falciparum infection\' or \'cerebral malaria". A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization.'}, {'measure': 'Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': 'Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules.'}, {'measure': 'Number of Subjects With Meningitis SAEs', 'timeFrame': 'From Year 0 to Year 3 (Starting January 2014 and ending December 2016)', 'description': "For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'."}, {'measure': 'Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)', 'timeFrame': 'At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)', 'description': 'Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points.'}]}, 'conditionsModule': {'keywords': ['Infants', 'Efficacy', 'Children', 'Malaria', 'Plasmodium falciparum', 'Safety', 'Surveillance', 'Immunogenicity', 'RTS,S/AS01E', 'Africa'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '31300331', 'type': 'BACKGROUND', 'citation': "Tinto H, Otieno W, Gesase S, Sorgho H, Otieno L, Liheluka E, Valea I, Sing'oei V, Malabeja A, Valia D, Wangwe A, Gvozdenovic E, Guerra Mendoza Y, Jongert E, Lievens M, Roman F, Schuerman L, Lusingu J. Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial. Lancet Infect Dis. 2019 Aug;19(8):821-832. doi: 10.1016/S1473-3099(19)30300-7. Epub 2019 Jul 9."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '42 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects' parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.\n* Written informed consent obtained from the parent(s)/LAR(s) of the subject.\n\nExclusion Criteria:\n\n* Child in care.\n* Use of any investigational or non-registered product or planned use during the study period."}, 'identificationModule': {'nctId': 'NCT02207816', 'briefTitle': "An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Extension to Study MALARIA-055 PRI (NCT00866619) for Evaluation of Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine (SB257049) in Infants and Children in Africa", 'orgStudyIdInfo': {'id': '200599'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK257049 Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.', 'interventionNames': ['Procedure: Blood sampling', 'Biological: Malaria Vaccine 257049 (MALARIA-055 PRI)', 'Biological: TritanrixHepB/Hib (MALARIA-055 PRI)', 'Biological: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GSK257049 Comparator Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.', 'interventionNames': ['Procedure: Blood sampling', 'Biological: Malaria Vaccine 257049 (MALARIA-055 PRI)', 'Biological: Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)', 'Biological: TritanrixHepB/Hib (MALARIA-055 PRI)', 'Biological: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VeroRab/Menjugate Comparator Group', 'description': 'Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.', 'interventionNames': ['Procedure: Blood sampling', 'Biological: Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)', 'Biological: Cell-culture rabies vaccine (MALARIA-055 PRI)', 'Biological: TritanrixHepB/Hib (MALARIA-055 PRI)', 'Biological: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)']}], 'interventions': [{'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.', 'armGroupLabels': ['GSK257049 Comparator Group', 'GSK257049 Group', 'VeroRab/Menjugate Comparator Group']}, {'name': 'Malaria Vaccine 257049 (MALARIA-055 PRI)', 'type': 'BIOLOGICAL', 'description': 'Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).', 'armGroupLabels': ['GSK257049 Comparator Group', 'GSK257049 Group']}, {'name': 'Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)', 'type': 'BIOLOGICAL', 'otherNames': ['Menjugate'], 'description': 'Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).', 'armGroupLabels': ['GSK257049 Comparator Group', 'VeroRab/Menjugate Comparator Group']}, {'name': 'Cell-culture rabies vaccine (MALARIA-055 PRI)', 'type': 'BIOLOGICAL', 'otherNames': ['VeroRab'], 'description': 'Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).', 'armGroupLabels': ['VeroRab/Menjugate Comparator Group']}, {'name': 'TritanrixHepB/Hib (MALARIA-055 PRI)', 'type': 'BIOLOGICAL', 'description': 'Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).', 'armGroupLabels': ['GSK257049 Comparator Group', 'GSK257049 Group', 'VeroRab/Menjugate Comparator Group']}, {'name': 'Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)', 'type': 'BIOLOGICAL', 'description': 'Administered orally, during the MALARIA-055 study (NCT00866619).', 'armGroupLabels': ['GSK257049 Comparator Group', 'GSK257049 Group', 'VeroRab/Menjugate Comparator Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'city': 'Kisumu', 'country': 'Kenya', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Tanga', 'country': 'Tanzania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -5.06893, 'lon': 39.09875}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=20045', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}