Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT00358332
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2006-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase I Pediatric FMP2.1/AS02A Trial in Mali
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011819', 'term': 'Rabies Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cplowe@medicine.umaryland.edu', 'phone': '410-706-3082', 'title': 'Christopher V. Plowe', 'organization': 'University of Maryland School of Medicine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.', 'description': 'The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event', 'eventGroups': [{'id': 'EG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.', 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.', 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dental discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 18, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Oral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Tooth loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 14, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Giardiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Herpetic stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hymenolepiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Infection parasitic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 20, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 25, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 25, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Mumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 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'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site swelling - - post dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia - post dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'title': 'Drowsiness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Irritability/Fussiness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Loss of Appetite', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Feverishness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 Days following any vaccination', 'description': 'The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome includes all enrolled subjects.'}, {'type': 'PRIMARY', 'title': 'Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of vaccination and 30 subsequent days.', 'description': 'The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome includes all enrolled subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Spontaneously Reporting Any Serious Adverse Event.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year after the last vaccination.', 'description': 'Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome includes all enrolled subjects.'}, {'type': 'SECONDARY', 'title': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.73', 'groupId': 'OG000', 'lowerLimit': '1.99', 'upperLimit': '3.47'}, {'value': '2.70', 'groupId': 'OG001', 'lowerLimit': '2.22', 'upperLimit': '3.17'}, {'value': '3.04', 'groupId': 'OG002', 'lowerLimit': '2.65', 'upperLimit': '3.42'}, {'value': '2.66', 'groupId': 'OG003', 'lowerLimit': '2.18', 'upperLimit': '3.14'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.', 'unitOfMeasure': 'log anti-FMP2.1 titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.'}, {'type': 'PRIMARY', 'title': 'Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'title': 'Site Pain', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 Days following any vaccination', 'description': 'The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome includes all enrolled subjects.'}, {'type': 'SECONDARY', 'title': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.09', 'groupId': 'OG000', 'lowerLimit': '3.78', 'upperLimit': '4.41'}, {'value': '4.20', 'groupId': 'OG001', 'lowerLimit': '4.04', 'upperLimit': '4.36'}, {'value': '4.31', 'groupId': 'OG002', 'lowerLimit': '4.18', 'upperLimit': '4.44'}, {'value': '2.57', 'groupId': 'OG003', 'lowerLimit': '2.05', 'upperLimit': '3.09'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30 +/- 7 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.', 'unitOfMeasure': 'log anti-FMP2.1 titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.'}, {'type': 'SECONDARY', 'title': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.78', 'groupId': 'OG000', 'lowerLimit': '4.61', 'upperLimit': '4.96'}, {'value': '4.98', 'groupId': 'OG001', 'lowerLimit': '4.84', 'upperLimit': '5.11'}, {'value': '4.97', 'groupId': 'OG002', 'lowerLimit': '4.89', 'upperLimit': '5.05'}, {'value': '2.53', 'groupId': 'OG003', 'lowerLimit': '2.03', 'upperLimit': '3.03'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 60 +/- 7 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.', 'unitOfMeasure': 'log anti-FMP2.1 titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.'}, {'type': 'SECONDARY', 'title': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.93', 'groupId': 'OG000', 'lowerLimit': '4.75', 'upperLimit': '5.11'}, {'value': '5.22', 'groupId': 'OG001', 'lowerLimit': '5.06', 'upperLimit': '5.37'}, {'value': '5.05', 'groupId': 'OG002', 'lowerLimit': '4.91', 'upperLimit': '5.19'}, {'value': '2.41', 'groupId': 'OG003', 'lowerLimit': '1.98', 'upperLimit': '2.84'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 90 +/- 10 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.', 'unitOfMeasure': 'log anti-FMP2.1 titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.'}, {'type': 'SECONDARY', 'title': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.53', 'groupId': 'OG000', 'lowerLimit': '4.33', 'upperLimit': '4.73'}, {'value': '4.73', 'groupId': 'OG001', 'lowerLimit': '4.60', 'upperLimit': '4.86'}, {'value': '4.57', 'groupId': 'OG002', 'lowerLimit': '4.42', 'upperLimit': '4.72'}, {'value': '2.15', 'groupId': 'OG003', 'lowerLimit': '1.75', 'upperLimit': '2.54'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 180 +/- 14 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.', 'unitOfMeasure': 'log anti-FMP2.1 titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.'}, {'type': 'SECONDARY', 'title': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.25', 'groupId': 'OG000', 'lowerLimit': '4.05', 'upperLimit': '4.45'}, {'value': '4.43', 'groupId': 'OG001', 'lowerLimit': '4.29', 'upperLimit': '4.58'}, {'value': '4.51', 'groupId': 'OG002', 'lowerLimit': '4.33', 'upperLimit': '4.70'}, {'value': '2.13', 'groupId': 'OG003', 'lowerLimit': '1.78', 'upperLimit': '2.48'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 272 +/- 14 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.', 'unitOfMeasure': 'log anti-FMP2.1 titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.'}, {'type': 'SECONDARY', 'title': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'OG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.36', 'groupId': 'OG000', 'lowerLimit': '4.16', 'upperLimit': '4.56'}, {'value': '4.68', 'groupId': 'OG001', 'lowerLimit': '4.46', 'upperLimit': '4.91'}, {'value': '4.42', 'groupId': 'OG002', 'lowerLimit': '4.27', 'upperLimit': '4.57'}, {'value': '2.56', 'groupId': 'OG003', 'lowerLimit': '2.20', 'upperLimit': '2.92'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 364 +/- 14 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.', 'unitOfMeasure': 'log anti-FMP2.1 titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point is available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'FG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'FG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'FG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Parents in Bandiagara Mali were made aware of the study by a radio announcement and voluntarily brought their children to the Bandiagara Malaria Project (BMP) clinic on the campus of the Bandiagara District Hospital in Bandiagara, Mali. The first subject was enrolled on November 3, 2006 and the final subject was enrolled on December 12, 2006.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'FMP2.1/AS02A 10 Mcg', 'description': 'Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'BG001', 'title': 'FMP2.1/AS02A 25 Mcg', 'description': 'Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'BG002', 'title': 'FMP2.1/AS02A 50 Mcg', 'description': 'Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'BG003', 'title': 'RabAvert(R)', 'description': 'Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '3.6', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '3.2', 'spread': '1.9', 'groupId': 'BG003'}, {'value': '3.4', 'spread': '1.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mali', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-18', 'studyFirstSubmitDate': '2006-07-27', 'resultsFirstSubmitDate': '2008-12-09', 'studyFirstSubmitQcDate': '2006-07-27', 'lastUpdatePostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-02-04', 'studyFirstPostDateStruct': {'date': '2006-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.', 'timeFrame': '7 Days following any vaccination', 'description': 'The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.'}, {'measure': 'Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60.', 'timeFrame': 'Day of vaccination and 30 subsequent days.', 'description': 'The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.'}, {'measure': 'Number of Subjects Spontaneously Reporting Any Serious Adverse Event.', 'timeFrame': '1 year after the last vaccination.', 'description': 'Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.'}, {'measure': 'Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.', 'timeFrame': '7 Days following any vaccination', 'description': 'The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.'}], 'secondaryOutcomes': [{'measure': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0', 'timeFrame': 'Day 0', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.'}, {'measure': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30', 'timeFrame': 'Day 30 +/- 7 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.'}, {'measure': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60', 'timeFrame': 'Day 60 +/- 7 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.'}, {'measure': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90', 'timeFrame': 'Day 90 +/- 10 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.'}, {'measure': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180', 'timeFrame': 'Day 180 +/- 14 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.'}, {'measure': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272.', 'timeFrame': 'Day 272 +/- 14 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.'}, {'measure': 'Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364', 'timeFrame': 'Day 364 +/- 14 days', 'description': 'This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.'}]}, 'conditionsModule': {'keywords': ['malaria, vaccine, Mali, children'], 'conditions': ['Plasmodium Falciparum Malaria']}, 'referencesModule': {'references': [{'pmid': '20140214', 'type': 'RESULT', 'citation': 'Thera MA, Doumbo OK, Coulibaly D, Laurens MB, Kone AK, Guindo AB, Traore K, Sissoko M, Diallo DA, Diarra I, Kouriba B, Daou M, Dolo A, Baby M, Sissoko MS, Sagara I, Niangaly A, Traore I, Olotu A, Godeaux O, Leach A, Dubois MC, Ballou WR, Cohen J, Thompson D, Dube T, Soisson L, Diggs CL, Takala SL, Lyke KE, House B, Lanar DE, Dutta S, Heppner DG, Plowe CV. Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial. PLoS One. 2010 Feb 4;5(2):e9041. doi: 10.1371/journal.pone.0009041.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to test the safety and dosages of a malaria vaccine in 100 children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine when it is given to people who are regularly exposed to malaria and it will provide information regarding optimal vaccine dosage. This study will compare 3 injections of different vaccine doses to a rabies vaccine that is already approved. During the study, the child's health will be checked in the clinic and during home visits. Children may participate for about 14 months, and blood will be taken from each child throughout the study. If the child becomes sick from malaria, he/she will be treated. Information from this study may be used to develop a malaria vaccine that will help control the disease.", 'detailedDescription': 'This study is a randomized, controlled, dose-escalation, phase I trial of the FMP2.1/AS02A malaria vaccine, using rabies vaccine as a control. This study is linked to DMID protocol 07-0003. The primary objective of this study is to evaluate the safety and reactogenicity of FMP2.1/AS02A in children naturally exposed to P. falciparum malaria infection. The secondary objective is to measure the magnitude and duration of antibody response to FMP2.1 by enzyme-linked immunosorbent assay (ELISA). One hundred healthy children aged 1-6 years in Bandiagara, Mali, will be randomized to 1 of 3 possible groups. Twenty subjects will be enrolled in cohort 1 and 40 subjects each in cohorts 2 and 3. Children within each cohort will be randomized in a 3:1 ratio to receive 10, 25 or 50 micrograms of FMP2.1 (in cohorts 1, 2 and 3, respectively) adjuvanted with a proportionate volume of the AS02A, or rabies vaccine. Thus a total of 75 children will receive the malaria vaccine and 25 the rabies vaccine. Immunizations will be given on days 0, 30 and 60 in a staggered fashion, with the first administrations of the 25 and 50 microgram dose levels of FMP2.1 following the first administration of the 10 and 25 microgram dose levels, respectively, by 2-3 weeks. Solicited adverse events will be recorded on the days of immunization and days 1, 2, 3 and 7 after each immunization, and unsolicited adverse events will be recorded for 30 days after each immunization. Children will be followed for 1 year after the last immunization. Sera will be collected for anti-FMP2.1 antibody titers on the days of immunization and 14 days after each immunization as well as 3, 6, 9 and 12 months after the first immunization. Each child will participate in the study for up to 414 days, which includes the screening period. The primary outcome measures include: occurrence of solicited symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3 and 7 after vaccination), occurrence of unsolicited symptoms after each vaccination during a 30-day surveillance period (day of vaccination and 30 subsequent days); and occurrence of serious adverse events throughout the study period. The secondary outcome measure is titers and activity of anti-FMP2.1 antibody at each time point where serology samples are analyzed, measured by ELISA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1-6 years inclusive at the time of screening.\n* Residing in Bandiagara town.\n* Appear to be in generally good health based on clinical and laboratory investigation.\n* Separate written informed consent obtained from the parent/guardian before screening and study start, respectively.\n* Available to participate in follow-up for the duration of study (14 months).\n\nExclusion Criteria:\n\n* Previous vaccination with an investigational vaccine or a rabies vaccine.\n* Use of a investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids.\n* Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.\n* Confirmed or suspected autoimmune disease.\n* History of allergic reactions or anaphylaxis to immunizations or to any vaccine component.\n* History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care.\n* History of allergy to tetracycline, doxycycline, nickel or Imidazole.\n* History of splenectomy.\n* Laboratory evidence of liver disease (alanine aminotransferase \\[ALT\\] greater than the upper limit of normal of the testing laboratory = 49.6 U/L).\n* Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory = 0.5 mg/dL (44.2 micromol/L), or more than trace protein or blood on urine dipstick testing).\n* Laboratory evidence of hematologic disease (absolute leukocyte count \\<5,300/mm\\^3 or \\>15,300/mm\\^3, absolute lymphocyte count \\<2,300 mm\\^3, platelet count \\<133,000/mm\\^3, or hemoglobin \\<9.0 g/dL).\n* Chronic skin condition that could interfere with vaccine site reactogenicity assessment.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period.\n* Simultaneous participation in any other interventional clinical trial.\n* Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, severe malnutrition, or any other clinical findings that in the opinion of the Principal Investigator (PI) may increase the risk of participating in the study.\n* Other condition that in the opinion of the PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.'}, 'identificationModule': {'nctId': 'NCT00358332', 'briefTitle': 'Phase I Pediatric FMP2.1/AS02A Trial in Mali', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': "Randomized, Controlled, Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of WRAIR's AMA-1 Malaria Vaccine (FMP2.1) Adjuvanted in GSKBio's AS02A Vs. Rabies Vaccine in 1-6 Year Old Children in Bandiagara, Mali", 'orgStudyIdInfo': {'id': '05-0146'}, 'secondaryIdInfos': [{'id': 'U19AI065683', 'link': 'https://reporter.nih.gov/quickSearch/U19AI065683', 'type': 'NIH'}, {'id': '2U01AI065683-06', 'link': 'https://reporter.nih.gov/quickSearch/2U01AI065683-06', 'type': 'NIH'}, {'id': 'GSKBio: Malaria 051 (106874)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine.', 'description': '20 children will be randomized to receive either the 10 mcg dose of FMP2.1/AS02A (n=15) or rabies vaccine (n=5) on study days 0, 30 +/- 7, and 60 +/- 7.', 'interventionNames': ['Biological: FMP2.1/AS02A', 'Biological: Rabies vaccine (RabAvert)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine.', 'description': '40 children will be randomized to receive either the 25 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7.', 'interventionNames': ['Biological: FMP2.1/AS02A', 'Biological: Rabies vaccine (RabAvert)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine.', 'description': '40 children will be randomized to receive either the 50 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7.', 'interventionNames': ['Biological: FMP2.1/AS02A', 'Biological: Rabies vaccine (RabAvert)']}], 'interventions': [{'name': 'FMP2.1/AS02A', 'type': 'BIOLOGICAL', 'description': 'FMP2.1 will be reconstituted in AS02A adjuvant. Dosages: 10, 25, or 50 mcg of FMP2.1 or 0.1, 0.25 or 0.5 mL of FMP2.1/AS02A administered by intramuscular injection.', 'armGroupLabels': ['Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine.', 'Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine.', 'Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine.']}, {'name': 'Rabies vaccine (RabAvert)', 'type': 'BIOLOGICAL', 'description': 'RabAvert, white, freeze-dried vaccine for reconstitution with diluent. Dosage: 1.0 mL of rabies vaccine.', 'armGroupLabels': ['Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine.', 'Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine.', 'Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bamako', 'country': 'Mali', 'facility': 'University of Bamako, Malaria Research and Training Center', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Walter Reed Army Institute of Research (WRAIR)', 'class': 'FED'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Director, ORA', 'oldOrganization': 'HHS/NIAID/DMID'}}}}