Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00380393
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2006-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).', 'eventGroups': [{'id': 'EG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.', 'otherNumAtRisk': 447, 'deathsNumAtRisk': 447, 'otherNumAffected': 385, 'seriousNumAtRisk': 447, 'deathsNumAffected': 1, 'seriousNumAffected': 51}, {'id': 'EG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.', 'otherNumAtRisk': 447, 'deathsNumAtRisk': 447, 'otherNumAffected': 396, 'seriousNumAtRisk': 447, 'deathsNumAffected': 0, 'seriousNumAffected': 88}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 64, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 43, 'numAffected': 40}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 120, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 90, 'numAffected': 81}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 59, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 172, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 157, 'numAffected': 130}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 195, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 188, 'numAffected': 141}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 149, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 409, 'numAffected': 268}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 81, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 64, 'numAffected': 59}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 96, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 59, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sickle cell anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ventricular septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebral malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Extrapulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Plasmodium falciparum infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Schistosomiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tinea capitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Petroleum distillate poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Kwashiorkor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Marasmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malignant mesenchymoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Foreign body aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of First Case of Malaria Meeting the Primary Case Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'With estimate of VE adjusted for covariates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '244.77', 'groupId': 'OG000'}, {'value': '238.51', 'groupId': 'OG001'}]}]}, {'title': 'With estimate of VE unadjusted for covariates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '249.23', 'groupId': 'OG000'}, {'value': '242.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.9', 'ciLowerLimit': '28.1', 'ciUpperLimit': '69.1', 'estimateComment': 'Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.', 'groupDescription': 'Vaccine efficacy against P. falciparum', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '55.0', 'ciLowerLimit': '31.4', 'ciUpperLimit': '70.4', 'estimateComment': 'Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.', 'groupDescription': 'Vaccine efficacy against P. falciparum', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (\\>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.', 'unitOfMeasure': 'PYAR', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Frequency of First Case Malaria Meeting the Secondary Case Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'With estimate of VE adjusted for covariates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '244.72', 'groupId': 'OG000'}, {'value': '237.21', 'groupId': 'OG001'}]}]}, {'title': 'With estimate of VE unadjusted for covariates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '249.17', 'groupId': 'OG000'}, {'value': '240.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.6', 'ciLowerLimit': '31.2', 'ciUpperLimit': '70.0', 'estimateComment': 'Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.', 'groupDescription': 'Vaccine efficacy against P. falciparum.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.5', 'ciLowerLimit': '34.2', 'ciUpperLimit': '71.2', 'estimateComment': 'Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.', 'groupDescription': 'Vaccine efficacy against P. falciparum.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'The first case of malaria meeting the secondary case definition was defined as the first or only episodes with the presence of P.falciparum asexual parasitemia \\> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.', 'unitOfMeasure': 'PYAR', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Multiple Events of Malaria Meeting the Primary Case Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'With estimate of VE adjusted for covariates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '253.69', 'groupId': 'OG000'}, {'value': '255.36', 'groupId': 'OG001'}]}]}, {'title': 'With estimate of VE unadjusted for covariates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '258.15', 'groupId': 'OG000'}, {'value': '259.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '55.8', 'ciLowerLimit': '31.0', 'ciUpperLimit': '71.7', 'estimateComment': 'Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.', 'groupDescription': 'Vaccine efficacy against P. falciparum.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.9', 'ciLowerLimit': '34.3', 'ciUpperLimit': '73.0', 'estimateComment': 'Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.', 'groupDescription': 'Vaccine efficacy against P. falciparum.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'Multiple episodes of malaria meeting the primary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \\> 25000 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of primary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.', 'unitOfMeasure': 'PYAR', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Multiple Events of Malaria Meeting the Secondary Case Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'With estimate of VE adjusted for covariates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '253.62', 'groupId': 'OG000'}, {'value': '255.06', 'groupId': 'OG001'}]}]}, {'title': 'With estimate of VE unadjusted for covariates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '258.07', 'groupId': 'OG000'}, {'value': '259.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.0', 'ciLowerLimit': '34.8', 'ciUpperLimit': '73.0', 'estimateComment': 'Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.', 'groupDescription': 'Vaccine efficacy against P. falciparum.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.5', 'ciLowerLimit': '37.1', 'ciUpperLimit': '73.9', 'estimateComment': 'Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.', 'groupDescription': 'Vaccine efficacy against P. falciparum.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'Multiple episodes of malaria meeting the secondary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \\> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of secondary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.', 'unitOfMeasure': 'PYAR', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Positive for P. Falciparum Parasitaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Density of Asexual P. Falciparum Parasite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '1020', 'groupId': 'OG000', 'lowerLimit': '135', 'upperLimit': '7720'}, {'value': '3486', 'groupId': 'OG001', 'lowerLimit': '557', 'upperLimit': '21813'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': "Estimates of asexual P. falciparum parasite density were made at the investigator's sites according to laboratory standard operating procedures. Parasite density was presented as a geometric mean (GMean), expressed in parasite per microliters (μL).", 'unitOfMeasure': 'parasites/μL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Haemoglobin Values at Cross-Sectional Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.32', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '10.37', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'Haemoglobin values are expressed in grams per deciliter (g/dL).', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Swelling 3 Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Swelling 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Swelling 3 Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Swelling 3 Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'Any Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were drowsiness, fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '349', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 30-day (Days 0-29) post-vaccination follow-up period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study period (Day 0 - Month 14)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'At Day 0', 'categories': [{'title': 'Normal', 'measurements': [{'value': '445', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At Month 3', 'categories': [{'title': 'Normal', 'measurements': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'At Cross-sectional Visit', 'categories': [{'title': 'Normal', 'measurements': [{'value': '391', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definitions for toxicity grading for hemoglobin were: Normal Hemoglobin = equal to or above (≥) 8.0 g/dL; Grade 1 Hemoglobin = under (\\<) 8.0 g/dL and above (\\>) 6.0 g/dL.; Grade 2 Hemoglobin = under (\\<) 6.0 g/dL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'At Day 0', 'categories': [{'title': 'Normal', 'measurements': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At Month 3', 'categories': [{'title': 'Normal', 'measurements': [{'value': '416', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'At Cross-sectional Visit', 'categories': [{'title': 'Normal', 'measurements': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definitions for toxicity grading for WBC were: Normal WBC = ≥ 4.0 x 10\\^3 cells per microliters (cells/μL) or \\< 17 x 10\\^3 cells /μL; Grade 1 WBC = 2.5 to 4.0 x 10\\^3 cells/μL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'At Day 0', 'categories': [{'title': 'Normal', 'measurements': [{'value': '445', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At Month 3', 'categories': [{'title': 'Normal', 'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'At Cross-sectional Visit', 'categories': [{'title': 'Normal', 'measurements': [{'value': '386', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definitions for toxicity grading for platelets were: Normal Platelets = ≥ 75 x 10\\^3 cells/μL; Grade 1 Platelets = 50 to 74 x 10\\^3 /μL; Grade 2 Platelets = 25 to 49 x 10\\^3 /μL; Grade 3 Platelets = \\< 25 x 10\\^3 /μL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'At Day 0', 'categories': [{'title': 'Normal', 'measurements': [{'value': '446', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At Month 3', 'categories': [{'title': 'Normal', 'measurements': [{'value': '413', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'At Cross-sectional Visit', 'categories': [{'title': 'Normal', 'measurements': [{'value': '393', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definition for toxicity grading for ALT were: Normal ALT = ≤ 60 international units per liter (IU/L); Grade 1 ALT = 1.1 to 2.5 x Upper Limit of Normal (ULN); Grade 2 ALT = 2.6 to 5.0 x ULN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'At Day 0', 'categories': [{'title': 'Normal', 'measurements': [{'value': '447', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At Month 3', 'categories': [{'title': 'Normal', 'measurements': [{'value': '415', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'At Cross-sectional Visit', 'categories': [{'title': 'Normal', 'measurements': [{'value': '397', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definition for toxicity grading for creatinine were: Normal Creatinine = ≤ 60 micromols per liter (μmol/L); Grade 1 Creatinine = 1.1 to 1.5 x ULN; Grade 2 Creatinine = 1.6 to 3.0 x ULN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'At Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.3'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.3'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '539.6', 'groupId': 'OG000', 'lowerLimit': '500.7', 'upperLimit': '581.6'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.3'}]}]}, {'title': 'At Cross-sectional Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000', 'lowerLimit': '65.7', 'upperLimit': '78.6'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'At Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155.4', 'groupId': 'OG000', 'lowerLimit': '134.6', 'upperLimit': '179.5'}, {'value': '187.4', 'groupId': 'OG001', 'lowerLimit': '161.8', 'upperLimit': '217.0'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46776.3', 'groupId': 'OG000', 'lowerLimit': '39018.3', 'upperLimit': '56076.8'}, {'value': '168.0', 'groupId': 'OG001', 'lowerLimit': '145.6', 'upperLimit': '193.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 and at Month 3', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'CD4-IFN-γ', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '55'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '56'}]}]}, {'title': 'CD4-IL-2', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '166'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '212'}]}]}, {'title': 'CD4-TNF-α', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '218'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '238'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Prior to vaccination (Day 0)', 'description': 'T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \\[IL-2\\], tumor-necrosis factor-alpha \\[TNF-α\\] and interferon-gamma \\[IFN-γ\\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).', 'unitOfMeasure': 'cells/million', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'CD8-IFN-γ', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '56'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '90'}]}]}, {'title': 'CD8-IL-2', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000', 'lowerLimit': '117', 'upperLimit': '417'}, {'value': '222', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '395'}]}]}, {'title': 'CD8-TNF-α', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '254'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '203'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Prior to vaccination (Day 0)', 'description': 'T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \\[IL-2\\], tumor-necrosis factor-alpha \\[TNF-α\\] and interferon-gamma \\[IFN-γ\\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).', 'unitOfMeasure': 'cells/million', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'CD4-IFN-γ', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '94'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '79'}]}]}, {'title': 'CD4-IL-2', 'categories': [{'measurements': [{'value': '648', 'groupId': 'OG000', 'lowerLimit': '359', 'upperLimit': '1342'}, {'value': '139', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '463'}]}]}, {'title': 'CD4-TNF-α', 'categories': [{'measurements': [{'value': '416', 'groupId': 'OG000', 'lowerLimit': '225', 'upperLimit': '755'}, {'value': '172', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '460'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Month 3', 'description': 'T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \\[IL-2\\], tumor-necrosis factor-alpha \\[TNF-α\\] and interferon-gamma \\[IFN-γ\\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).', 'unitOfMeasure': 'cells/million', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'classes': [{'title': 'CD8-IFN-γ', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '158'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '160'}]}]}, {'title': 'CD8-IL-2', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000', 'lowerLimit': '131', 'upperLimit': '428'}, {'value': '219', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '459'}]}]}, {'title': 'CD8-TNF-α', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000', 'lowerLimit': '104', 'upperLimit': '407'}, {'value': '185', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '390'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Month 3', 'description': 'T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \\[IL-2\\], tumor-necrosis factor-alpha \\[TNF-α\\] and interferon-gamma \\[IFN-γ\\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).', 'unitOfMeasure': 'cells/million', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'FG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}], 'periods': [{'title': 'Month 8 (Cross-sectional Visit)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '447'}, {'groupId': 'FG001', 'numSubjects': '447'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '398'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Month 14', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '447'}, {'groupId': 'FG001', 'numSubjects': '447'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}, {'groupId': 'FG001', 'numSubjects': '391'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '894', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'BG001', 'title': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '894', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '11.4', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '11.4', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '894', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 894}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'dispFirstSubmitDate': '2009-09-03', 'completionDateStruct': {'date': '2008-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-04', 'studyFirstSubmitDate': '2006-09-25', 'dispFirstSubmitQcDate': '2009-09-03', 'resultsFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2006-09-25', 'dispFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-04', 'studyFirstPostDateStruct': {'date': '2006-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of First Case of Malaria Meeting the Primary Case Definition', 'timeFrame': 'Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (\\>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.'}], 'secondaryOutcomes': [{'measure': 'Frequency of First Case Malaria Meeting the Secondary Case Definition', 'timeFrame': 'Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'The first case of malaria meeting the secondary case definition was defined as the first or only episodes with the presence of P.falciparum asexual parasitemia \\> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.'}, {'measure': 'Multiple Events of Malaria Meeting the Primary Case Definition', 'timeFrame': 'Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'Multiple episodes of malaria meeting the primary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \\> 25000 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of primary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.'}, {'measure': 'Multiple Events of Malaria Meeting the Secondary Case Definition', 'timeFrame': 'Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'Multiple episodes of malaria meeting the secondary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \\> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of secondary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.'}, {'measure': 'Number of Subjects Positive for P. Falciparum Parasitaemia', 'timeFrame': 'At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)'}, {'measure': 'Geometric Mean Density of Asexual P. Falciparum Parasite', 'timeFrame': 'At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': "Estimates of asexual P. falciparum parasite density were made at the investigator's sites according to laboratory standard operating procedures. Parasite density was presented as a geometric mean (GMean), expressed in parasite per microliters (μL)."}, {'measure': 'Haemoglobin Values at Cross-Sectional Visit', 'timeFrame': 'At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)', 'description': 'Haemoglobin values are expressed in grams per deciliter (g/dL).'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were drowsiness, fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within the 30-day (Days 0-29) post-vaccination follow-up period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'Throughout the study period (Day 0 - Month 14)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definitions for toxicity grading for hemoglobin were: Normal Hemoglobin = equal to or above (≥) 8.0 g/dL; Grade 1 Hemoglobin = under (\\<) 8.0 g/dL and above (\\>) 6.0 g/dL.; Grade 2 Hemoglobin = under (\\<) 6.0 g/dL.'}, {'measure': 'Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definitions for toxicity grading for WBC were: Normal WBC = ≥ 4.0 x 10\\^3 cells per microliters (cells/μL) or \\< 17 x 10\\^3 cells /μL; Grade 1 WBC = 2.5 to 4.0 x 10\\^3 cells/μL.'}, {'measure': 'Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definitions for toxicity grading for platelets were: Normal Platelets = ≥ 75 x 10\\^3 cells/μL; Grade 1 Platelets = 50 to 74 x 10\\^3 /μL; Grade 2 Platelets = 25 to 49 x 10\\^3 /μL; Grade 3 Platelets = \\< 25 x 10\\^3 /μL.'}, {'measure': 'Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definition for toxicity grading for ALT were: Normal ALT = ≤ 60 international units per liter (IU/L); Grade 1 ALT = 1.1 to 2.5 x Upper Limit of Normal (ULN); Grade 2 ALT = 2.6 to 5.0 x ULN.'}, {'measure': 'Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Definition for toxicity grading for creatinine were: Normal Creatinine = ≤ 60 micromols per liter (μmol/L); Grade 1 Creatinine = 1.1 to 1.5 x ULN; Grade 2 Creatinine = 1.6 to 3.0 x ULN.'}, {'measure': 'Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS)', 'timeFrame': 'At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).'}, {'measure': 'Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs)', 'timeFrame': 'At Day 0 and at Month 3', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).'}, {'measure': 'Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells', 'timeFrame': 'Prior to vaccination (Day 0)', 'description': 'T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \\[IL-2\\], tumor-necrosis factor-alpha \\[TNF-α\\] and interferon-gamma \\[IFN-γ\\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).'}, {'measure': 'Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells', 'timeFrame': 'Prior to vaccination (Day 0)', 'description': 'T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \\[IL-2\\], tumor-necrosis factor-alpha \\[TNF-α\\] and interferon-gamma \\[IFN-γ\\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).'}, {'measure': 'Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells', 'timeFrame': 'At Month 3', 'description': 'T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \\[IL-2\\], tumor-necrosis factor-alpha \\[TNF-α\\] and interferon-gamma \\[IFN-γ\\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).'}, {'measure': 'Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells', 'timeFrame': 'At Month 3', 'description': 'T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \\[IL-2\\], tumor-necrosis factor-alpha \\[TNF-α\\] and interferon-gamma \\[IFN-γ\\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).'}]}, 'conditionsModule': {'keywords': ['Malaria', 'Plasmodium', 'RTS', 'S/AS01', 'Falciparum'], 'conditions': ['Malaria']}, 'referencesModule': {'availIpds': [{'id': '106464', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '106464', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '106464', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '106464', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '106464', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '106464', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '19064627', 'type': 'BACKGROUND', 'citation': 'Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, Mshamu S, Lang T, Gould J, Dubois MC, Demoitie MA, Stallaert JF, Vansadia P, Carter T, Njuguna P, Awuondo KO, Malabeja A, Abdul O, Gesase S, Mturi N, Drakeley CJ, Savarese B, Villafana T, Ballou WR, Cohen J, Riley EM, Lemnge MM, Marsh K, von Seidlein L. Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. N Engl J Med. 2008 Dec 11;359(24):2521-32. doi: 10.1056/NEJMoa0807381. Epub 2008 Dec 8.'}, {'pmid': '24030880', 'type': 'BACKGROUND', 'citation': 'Lang TA, Gould J, von Seidlein L, Lusingu JP, Mshamu S, Ismael S, Liheluka E, Kamuya D, Mwachiro D, Olotu A, Njuguna P, Bejon P, Marsh V, Molyneux C. Approaching the community about screening children for a multicentre malaria vaccine trial. Int Health. 2012 Mar;4(1):47-54. doi: 10.1016/j.inhe.2011.10.003.'}, {'pmid': '21124768', 'type': 'BACKGROUND', 'citation': 'Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, Olivier A, Benns S, Olomi R, Msham S, Lang T, Gould J, Hallez K, Guerra Y, Njuguna P, Awuondo KO, Malabeja A, Abdul O, Gesase S, Dekker D, Malle L, Ismael S, Mturi N, Drakeley CJ, Savarese B, Villafana T, Ballou WR, Cohen J, Riley EM, Lemnge MM, Marsh K, Bejon P, von Seidlein L. Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian Children. PLoS One. 2010 Nov 29;5(11):e14090. doi: 10.1371/journal.pone.0014090.'}, {'pmid': '21237715', 'type': 'BACKGROUND', 'citation': 'Olotu A, Lusingu J, Leach A, Lievens M, Vekemans J, Msham S, Lang T, Gould J, Dubois MC, Jongert E, Vansadia P, Carter T, Njuguna P, Awuondo KO, Malabeja A, Abdul O, Gesase S, Mturi N, Drakeley CJ, Savarese B, Villafana T, Lapierre D, Ballou WR, Cohen J, Lemnge MM, Peshu N, Marsh K, Riley EM, von Seidlein L, Bejon P. Efficacy of RTS,S/AS01E malaria vaccine and exploratory analysis on anti-circumsporozoite antibody titres and protection in children aged 5-17 months in Kenya and Tanzania: a randomised controlled trial. Lancet Infect Dis. 2011 Feb;11(2):102-9. doi: 10.1016/S1473-3099(10)70262-0. Epub 2011 Jan 13.'}, {'pmid': '25506706', 'type': 'DERIVED', 'citation': 'Olotu A, Clement F, Jongert E, Vekemans J, Njuguna P, Ndungu FM, Marsh K, Leroux-Roels G, Bejon P. Avidity of anti-circumsporozoite antibodies following vaccination with RTS,S/AS01E in young children. PLoS One. 2014 Dec 15;9(12):e115126. doi: 10.1371/journal.pone.0115126. eCollection 2014.'}, {'pmid': '23962071', 'type': 'DERIVED', 'citation': 'Warimwe GM, Fletcher HA, Olotu A, Agnandji ST, Hill AV, Marsh K, Bejon P. Peripheral blood monocyte-to-lymphocyte ratio at study enrollment predicts efficacy of the RTS,S malaria vaccine: analysis of pooled phase II clinical trial data. BMC Med. 2013 Aug 21;11:184. doi: 10.1186/1741-7015-11-184.'}, {'pmid': '22504653', 'type': 'DERIVED', 'citation': 'Horowitz A, Hafalla JC, King E, Lusingu J, Dekker D, Leach A, Moris P, Cohen J, Vekemans J, Villafana T, Corran PH, Bejon P, Drakeley CJ, von Seidlein L, Riley EM. Antigen-specific IL-2 secretion correlates with NK cell responses after immunization of Tanzanian children with the RTS,S/AS01 malaria vaccine. J Immunol. 2012 May 15;188(10):5054-62. doi: 10.4049/jimmunol.1102710. Epub 2012 Apr 13.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Months', 'minimumAge': '5 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female child of between 5 months and 17 months of age at the time of first vaccination.\n* Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child..\n* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.\n\nExclusion Criteria:\n\n* Acute disease at the time of enrolment.\n* Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.\n* Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.\n* Planned administration/administration of a vaccine not foreseen by the study within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled diphtheria, pertussis or measles vaccine.\n* Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose\n* Previous participation in any other malaria vaccine trial.\n* Simultaneous participation in any other clinical trial.\n* Same sex twin.\n* History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.'}, 'identificationModule': {'nctId': 'NCT00380393', 'briefTitle': 'Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS,S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya', 'orgStudyIdInfo': {'id': '106464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK257049 Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.', 'interventionNames': ['Biological: GSK malaria vaccine 257049 Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rabipur Group', 'description': 'Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.', 'interventionNames': ["Biological: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine"]}], 'interventions': [{'name': 'GSK malaria vaccine 257049 Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['RTS', 'S/AS01E vaccine'], 'description': '3 dose intramuscular injection', 'armGroupLabels': ['GSK257049 Group']}, {'name': "Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine", 'type': 'BIOLOGICAL', 'description': '3 dose intramuscular injection', 'armGroupLabels': ['Rabipur Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80108', 'city': 'Kilifi', 'country': 'Kenya', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -3.63045, 'lon': 39.84992}}, {'city': 'Amani, Tanga', 'country': 'Tanzania', 'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}