Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-01 @ 2:25 PM
Study NCT ID:
NCT02458092
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2015-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B
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': {'email': 'notsyula@wrp-ksm.org', 'phone': '254-722-239-828', 'title': 'Nekoye Otsyula', 'organization': 'US Army Medical Research Unit - Kenya'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day 0 - 146', 'eventGroups': [{'id': 'EG000', 'title': '50 µg of FMP010 Antigen in 0.5 mL AS01B Adjuvant', 'description': '50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant given intramuscularly in the deltoid muscle of the non-dominant arm.\n\nPlasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rabies Vaccine Rabipur', 'description': 'Rabies Vaccine Rabipur given intramuscularly in the deltoid muscle of the non-dominant arm.\n\nRabipur: Rabipur is a licensed rabies vaccine.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abscesses on lower limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abscesses right medial malleolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute colitis (infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute gastroenteritis (amoebiasis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Allergic conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Allergic conjunctivitis (both eyes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Allergic cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Allergic skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthritis in both knee joints', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest pain (musculoskeletal)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chills and rigors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Conjunctivitis (both eyes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Conjunctivitis (left eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Decreased neutrophil count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Decreased white blood cell count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Drop in hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Drop in neutrophil count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Drop in platelet count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Elbow joint pain bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Elevated ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Entrocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eye strain both eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fullness of chest related heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fungal dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'General body aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'General body weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Generalized joint pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Generalized malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Giardiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Herpes labialis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hot flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hotness of body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Itchiness of ears (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Itchiness of injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lumbago', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lumbosacral back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Mild cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Mild drop in neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscular neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscular pain lower back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 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'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain at circumcision site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain both eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain left face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain on the left elbow joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain right shin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus of the interphalangeal spaces, both feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 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0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Right chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Right joint (hip) pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 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{'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Soft tissue injury left foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Soft tissue injury left heel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Soft tissue injury left shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Soft tissue injury right foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Soft tissue injury right hand', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Soft tissue injury right wrist joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sore mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Subjective fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Subjective weakness of the left upper limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Suidical ideations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tooth pain secodnary to dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tooth sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Weakness of left arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Adverse Events With Each Vaccination by Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant', 'description': 'Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. 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'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No experiences', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Immunization 1: Malaise', 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', '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': 'No experiences', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Immunization 1: Myalgia', 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 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{'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No experiences', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Immunization: Local redness', 'categories': [{'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': 'No experiences', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Immunization 1: Local swelling', 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', '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': 'No experiences', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Immunization 2: Fever', 'categories': [{'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': 'No experiences', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Immunization 2: Fatigue', 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Grade 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[{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No experiences', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Immunization 2: Local redness', 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', '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': 'No experiences', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Immunization 2: Local swelling', 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', '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': 'No experiences', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Immunization 3: Fever', 'categories': [{'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': 'No experiences', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Immunization 3: 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Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Unsolicited Adverse Events at Specified Grades', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant', 'description': 'Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.'}, {'id': 'OG001', 'title': 'Rabies Vaccine Rabipur', 'description': 'Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After each vaccination (Day 0), 30 day f/u period post vaccination', 'description': 'Vaccinations were given at 0-, 1-, 2-month interval, number of subjects reporting unsolicited symptoms at specified grades over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination\n\nGrade 1 = Mild Grade 2 = Moderate Grade 3 = Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With the Occurrence of Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant', 'description': 'Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.'}, {'id': 'OG001', 'title': 'Rabies Vaccine Rabipur', 'description': 'Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 post vaccination', 'description': 'Vaccinations were given at 0-, 1-, 2-month interval, number of subjects with the occurrence of serious adverse events at days 0-7 post vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant', 'description': 'Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.'}], 'classes': [{'title': 'Subject 00423: Day0', 'categories': [{'measurements': [{'value': '44720.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 00423: Day14', 'categories': [{'measurements': [{'value': '54644.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 00423: Day28', 'categories': [{'measurements': [{'value': '51390.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 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'NA'}]}]}, {'title': 'Subject 00906: Day42', 'categories': [{'measurements': [{'value': '36532.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 00906: Day56', 'categories': [{'measurements': [{'value': '21780.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 00906: Day70', 'categories': [{'measurements': [{'value': '36438.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 00906: Day112', 'categories': [{'measurements': [{'value': '14994.0', 'comment': 'CI was not included in the tables 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'NA'}]}]}, {'title': 'Subject 02708: Day42', 'categories': [{'measurements': [{'value': '61350.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 02708: Day56', 'categories': [{'measurements': [{'value': '40838.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subect 02708: Day70', 'categories': [{'measurements': [{'value': '66650.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 02708: Day112', 'categories': [{'measurements': [{'value': '57170.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03401: Day0', 'categories': [{'measurements': [{'value': '2215.7', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03401: Day14', 'categories': [{'measurements': [{'value': '10186.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03401: Day28', 'categories': [{'measurements': [{'value': '6060.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03401: Day42', 'categories': [{'measurements': [{'value': '62353.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03401: Day56', 'categories': [{'measurements': [{'value': '30647.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03401: Day70', 'categories': [{'measurements': [{'value': '70680.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03401: Day112', 'categories': [{'measurements': [{'value': '45400.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03814: Day0', 'categories': [{'measurements': [{'value': '15190.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03814: Day14', 'categories': [{'measurements': [{'value': '45280.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03814: Day28', 'categories': [{'measurements': [{'value': '44100.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03814: Day42', 'categories': [{'measurements': [{'value': '83150.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03814: Day56', 'categories': [{'measurements': [{'value': '137740.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03814: Day70', 'categories': [{'measurements': [{'value': '80160.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 03814: Day112', 'categories': [{'measurements': [{'value': '99760.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 05029: Day0', 'categories': [{'measurements': [{'value': '4151.5', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 05029: Day14', 'categories': [{'measurements': [{'value': '15949.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 05029: Day28', 'categories': [{'measurements': [{'value': '21873.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 05029: Day42', 'categories': [{'measurements': [{'value': '92010.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 05029: Day56', 'categories': [{'measurements': [{'value': '58170.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 05029: Day70', 'categories': [{'measurements': [{'value': '74950.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 05029: Day112', 'categories': [{'measurements': [{'value': '41140.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06020: Day0', 'categories': [{'measurements': [{'value': '45960.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06020: Day14', 'categories': [{'measurements': [{'value': '45690.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06020: Day28', 'categories': [{'measurements': [{'value': '48483.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06020: Day42', 'categories': [{'measurements': [{'value': '65830.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06020: Day56', 'categories': [{'measurements': [{'value': '79880.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06020: Day70', 'categories': [{'measurements': [{'value': '68280.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06020: Day112', 'categories': [{'measurements': [{'value': '54958.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06627: Day0', 'categories': [{'measurements': [{'value': '3926.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06627: Day14', 'categories': [{'measurements': [{'value': '10662.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06627: Day28', 'categories': [{'measurements': [{'value': '8919.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06627: Day42', 'categories': [{'measurements': [{'value': '12677.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06627: Day56', 'categories': [{'measurements': [{'value': '10673.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06627: Day70', 'categories': [{'measurements': [{'value': '12201.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 06627: Day112', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 07722: Day0', 'categories': [{'measurements': [{'value': '399.6', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 07722: Day14', 'categories': [{'measurements': [{'value': '1500.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 07722: Day28', 'categories': [{'measurements': [{'value': '970.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 07722: Day42', 'categories': [{'measurements': [{'value': '55140.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 07722: Day56', 'categories': [{'measurements': [{'value': '39952.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 07722: Day70', 'categories': [{'measurements': [{'value': '127770.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 07722: Day112', 'categories': [{'measurements': [{'value': '40950.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08904: Day0', 'categories': [{'measurements': [{'value': '1751.8', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08904: Day14', 'categories': [{'measurements': [{'value': '2656.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08904: Day28', 'categories': [{'measurements': [{'value': '2176.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08904: Day42', 'categories': [{'measurements': [{'value': '19760.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08904: Day56', 'categories': [{'measurements': [{'value': '11798.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08904: Day70', 'categories': [{'measurements': [{'value': '16158.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08904: Day112', 'categories': [{'measurements': [{'value': '13393.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09105: Day0', 'categories': [{'measurements': [{'value': '37.7', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09105: Day14', 'categories': [{'measurements': [{'value': '567.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09105: Day28', 'categories': [{'measurements': [{'value': '1318.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09105: Day42', 'categories': [{'measurements': [{'value': '132810.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09105: Day56', 'categories': [{'measurements': [{'value': '37366.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09105: Day70', 'categories': [{'measurements': [{'value': '121030.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09105: Day112', 'categories': [{'measurements': [{'value': '30260.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09621: Day0', 'categories': [{'measurements': [{'value': '6147.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09621: Day14', 'categories': [{'measurements': [{'value': '15889.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09621: Day28', 'categories': [{'measurements': [{'value': '15213.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09621: Day42', 'categories': [{'measurements': [{'value': '32252.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09621: Day56', 'categories': [{'measurements': [{'value': '19676.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09621: Day70', 'categories': [{'measurements': [{'value': '53608.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09621: Day112', 'categories': [{'measurements': [{'value': '26482.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09913: Day0', 'categories': [{'measurements': [{'value': '29480.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09913: Day14', 'categories': [{'measurements': [{'value': '32260.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09913: Day28', 'categories': [{'measurements': [{'value': '27302.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09913: Day42', 'categories': [{'measurements': [{'value': '80040.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09913: Day56', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09913: Day72', 'categories': [{'measurements': [{'value': '76470.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09913: Day112', 'categories': [{'measurements': [{'value': '114600.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10015: Day0', 'categories': [{'measurements': [{'value': '2007.5', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10015: Day14', 'categories': [{'measurements': [{'value': '6241.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10015: Day28', 'categories': [{'measurements': [{'value': '6617.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10015: Day42', 'categories': [{'measurements': [{'value': '53650.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10015: Day56', 'categories': [{'measurements': [{'value': '311250.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10015: Day70', 'categories': [{'measurements': [{'value': '205460.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10015: Day112', 'categories': [{'measurements': [{'value': '149250.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10916: Day0', 'categories': [{'measurements': [{'value': '28200.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10916: Day14', 'categories': [{'measurements': [{'value': '53252.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10916: Day28', 'categories': [{'measurements': [{'value': '61407.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10916: Day42', 'categories': [{'measurements': [{'value': '68040.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10916: Day56', 'categories': [{'measurements': [{'value': '71610.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10916: Day70', 'categories': [{'measurements': [{'value': '60950.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10916: Day112', 'categories': [{'measurements': [{'value': '81650.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12217: Day0', 'categories': [{'measurements': [{'value': '6603.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12217: Day14', 'categories': [{'measurements': [{'value': '11804.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12217: Day28', 'categories': [{'measurements': [{'value': '10355.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12217: Day42', 'categories': [{'measurements': [{'value': '48342.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12217: Day56', 'categories': [{'measurements': [{'value': '24537.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12217: Day70', 'categories': [{'measurements': [{'value': '78190.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12217: Day112', 'categories': [{'measurements': [{'value': '45929.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12518: Day0', 'categories': [{'measurements': [{'value': '2051.6', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12518: Day14', 'categories': [{'measurements': [{'value': '4403.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12518: Day28', 'categories': [{'measurements': [{'value': '2214.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12518: Day42', 'categories': [{'measurements': [{'value': '78680.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12518: Day56', 'categories': [{'measurements': [{'value': '27675.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12518: Day70', 'categories': [{'measurements': [{'value': '126160.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12518: Day112', 'categories': [{'measurements': [{'value': '38900.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12612: Day0', 'categories': [{'measurements': [{'value': '1852.4', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12612: Day14', 'categories': [{'measurements': [{'value': '1545.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12612: Day28', 'categories': [{'measurements': [{'value': '979.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12612: Day42', 'categories': [{'measurements': [{'value': '7536.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12612: Day56', 'categories': [{'measurements': [{'value': '4067.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12612: Day70', 'categories': [{'measurements': [{'value': '23216.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12612: Day112', 'categories': [{'measurements': [{'value': '11960.0', 'comment': 'CCI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 13209: Day0', 'categories': [{'measurements': [{'value': '940.8', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 13209: Day14', 'categories': [{'measurements': [{'value': '2506.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 13209: Day28', 'categories': [{'measurements': [{'value': '2988.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 13209: Day42', 'categories': [{'measurements': [{'value': '153550.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 13209: Day 56', 'categories': [{'measurements': [{'value': '900000.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 13209: Day70', 'categories': [{'measurements': [{'value': '110650.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 13209: Day112', 'categories': [{'measurements': [{'value': '38390.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112', 'description': "Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) (not presented in results), at each time point at which blood samples are taken for serology.\n\nPeak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.", 'unitOfMeasure': 'Geometric Mean Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rabies Vaccine Rabipur', 'description': 'Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.'}], 'classes': [{'title': 'Subject 01603: Day0', 'categories': [{'measurements': [{'value': '20580.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01603: Day14', 'categories': [{'measurements': [{'value': '23707.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01603: Day28', 'categories': [{'measurements': [{'value': '22537.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01603: Day42', 'categories': [{'measurements': [{'value': '24090.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01603: Day56', 'categories': [{'measurements': [{'value': '42005.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01603: Day70', 'categories': [{'measurements': [{'value': '43723.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01603: Day112', 'categories': [{'measurements': [{'value': '32104.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01702: Day0', 'categories': [{'measurements': [{'value': '71.5', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01702: Day14', 'categories': [{'measurements': [{'value': '84.3', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01702: Day28', 'categories': [{'measurements': [{'value': '53.2', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01702: Day42', 'categories': [{'measurements': [{'value': '57.8', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01702: Day56', 'categories': [{'measurements': [{'value': '65.1', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01702: Day70', 'categories': [{'measurements': [{'value': '73.6', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 01702: Day112', 'categories': [{'measurements': [{'value': '42.1', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04026: Day0', 'categories': [{'measurements': [{'value': '122.6', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04026: Day14', 'categories': [{'measurements': [{'value': '103.2', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04026: Day28', 'categories': [{'measurements': [{'value': '109.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04026: Day42', 'categories': [{'measurements': [{'value': '77.5', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04026: Day56', 'categories': [{'measurements': [{'value': '1000.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04026: Day70', 'categories': [{'measurements': [{'value': '544.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04026: Day112', 'categories': [{'measurements': [{'value': '125.8', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04328: Day0', 'categories': [{'measurements': [{'value': '5226.3', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04328: Day14', 'categories': [{'measurements': [{'value': '3782.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04328: Day28', 'categories': [{'measurements': [{'value': '4560.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04328: Day42', 'categories': [{'measurements': [{'value': '3788.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04328: Day56', 'categories': [{'measurements': [{'value': '2914.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04328: Day70', 'categories': [{'measurements': [{'value': '1920.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 04328: Day112', 'categories': [{'measurements': [{'value': '1802.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08725: Day0', 'categories': [{'measurements': [{'value': '27240.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08725: Day14', 'categories': [{'measurements': [{'value': '29477.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08725: Day28', 'categories': [{'measurements': [{'value': '26786.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08725: Day42', 'categories': [{'measurements': [{'value': '17866.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08725: Day56', 'categories': [{'measurements': [{'value': '13819.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08725: Day70', 'categories': [{'measurements': [{'value': '9601.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 08725: Day112', 'categories': [{'measurements': [{'value': '9898.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09211: Day0', 'categories': [{'measurements': [{'value': '2347.1', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09211: Day14', 'categories': [{'measurements': [{'value': '2250.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09211: Day28', 'categories': [{'measurements': [{'value': '2794.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09211: Day42', 'categories': [{'measurements': [{'value': '1952.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09211: Day56', 'categories': [{'measurements': [{'value': '1378.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09211: Day70', 'categories': [{'measurements': [{'value': '1232.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 09211: Day112', 'categories': [{'measurements': [{'value': '1991.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10324: Day0', 'categories': [{'measurements': [{'value': '3970.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10324: Day14', 'categories': [{'measurements': [{'value': '4493.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10324: Day28', 'categories': [{'measurements': [{'value': '3781.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10324: Day42', 'categories': [{'measurements': [{'value': '2891.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10324: Day56', 'categories': [{'measurements': [{'value': '3849.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10324: Day70', 'categories': [{'measurements': [{'value': '1901.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10324: Day112', 'categories': [{'measurements': [{'value': '1381.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10810: Day0', 'categories': [{'measurements': [{'value': '49410.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10810: Day14', 'categories': [{'measurements': [{'value': '41500.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10810: Day28', 'categories': [{'measurements': [{'value': '45920.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10810: Day42', 'categories': [{'measurements': [{'value': '49386.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10810: Day56', 'categories': [{'measurements': [{'value': '32158.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10810: Day70', 'categories': [{'measurements': [{'value': '39979.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 10810: Day112', 'categories': [{'measurements': [{'value': '36962.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 11819: Day0', 'categories': [{'measurements': [{'value': '9669.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 11819: Day14', 'categories': [{'measurements': [{'value': '11155.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 11819: Day28', 'categories': [{'measurements': [{'value': '10008.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 11819: Day42', 'categories': [{'measurements': [{'value': '9381.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 11819: Day56', 'categories': [{'measurements': [{'value': '6355.0', 'comment': 'CCI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 11819: Day70', 'categories': [{'measurements': [{'value': '5276.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 11819: Day112', 'categories': [{'measurements': [{'value': '5921.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12330: Day0', 'categories': [{'measurements': [{'value': '1117.6', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12330: Day14', 'categories': [{'measurements': [{'value': '1291.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12330: Day28', 'categories': [{'measurements': [{'value': '1392.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12330: Day42', 'categories': [{'measurements': [{'value': '1105.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12330: Day56', 'categories': [{'measurements': [{'value': '734.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12330: Day70', 'categories': [{'measurements': [{'value': '858.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subject 12330: Day112', 'categories': [{'measurements': [{'value': '852.0', 'comment': 'CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112', 'description': "Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) at each time point at which blood samples are taken for serology.\n\nPeak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.", 'unitOfMeasure': 'Geometric Mean Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant', 'description': 'Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.'}, {'id': 'FG001', 'title': 'Rabies Vaccine Rabipur', 'description': 'Rabipur: Rabipur is a licensed rabies vaccine (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '30 healthy, malaria-experienced adults were enrolled and randomized into 2 groups at Walter Reed Project/Kenya Medical Research Institute (KEMRI) Kisumu, Kenya.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant', 'description': 'Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK'}, {'id': 'BG001', 'title': 'Rabies Vaccine Rabipur', 'description': 'Rabipur: Rabipur is a licensed rabies vaccine.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Luo', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Lulya', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2015-05-27', 'resultsFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2015-05-28', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-27', 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Solicited Adverse Events With Each Vaccination by Grade', 'timeFrame': 'After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7', 'description': 'Vaccinations were given at 0-, 1-, 2-month interval, occurrence and intensity of solicited symptoms on day of vaccination (Day 0) and Days 1-7 after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events at Specified Grades', 'timeFrame': 'After each vaccination (Day 0), 30 day f/u period post vaccination', 'description': 'Vaccinations were given at 0-, 1-, 2-month interval, number of subjects reporting unsolicited symptoms at specified grades over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination\n\nGrade 1 = Mild Grade 2 = Moderate Grade 3 = Severe'}, {'measure': 'Number of Subjects With the Occurrence of Serious Adverse Events', 'timeFrame': 'After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 post vaccination', 'description': 'Vaccinations were given at 0-, 1-, 2-month interval, number of subjects with the occurrence of serious adverse events at days 0-7 post vaccination'}], 'secondaryOutcomes': [{'measure': 'Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group', 'timeFrame': 'After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112', 'description': "Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) (not presented in results), at each time point at which blood samples are taken for serology.\n\nPeak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data."}, {'measure': 'Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group', 'timeFrame': 'After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112', 'description': "Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) at each time point at which blood samples are taken for serology.\n\nPeak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Malaria']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.', 'detailedDescription': 'Study is to evaluate the safety, reactogenicity, and immunogenicity fo the candidate Plasmodium falciparum malaria protein 10 (FMP010). Malaria-experienced adults will be enrolled and randomized into 2 groups. Subjects will receive full dose FMP010 antigen (approximately 50 μg) in 0.5 mL AS01B adjuvant or licensed rabies vaccine Rabipur (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • A male or non-lactating female 18 to 50 years of age (inclusive) at the time of screening\n\n * Free of significant health problems as established by medical history and clinical examination before entering into the study\n * Available to participate for duration of study (approximately seven months)\n\nIf the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must have a negative pregnancy test at the time of vaccination, be capable of preventing pregnancy for at least one month prior to determination of eligibility (to include abstinence or contraceptives (for example intrauterine contraceptive device; oral contraceptives; Norplant® or Depo-Provera® ), and must agree to continue such precautions for two months after completion of the vaccination series.\n\nWritten informed consent must be obtained from the subject before screening procedures.\n\nExclusion Criteria:\n\n* • Prior receipt of any investigational malaria vaccine\n\n * Prior receipt of a vaccine containing either QS-21, MPL or AS02A or AS01B\n * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period\n * Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within six months of vaccination. For corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.\n * Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the study vaccine.\n * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection\n * A family history of congenital or hereditary immunodeficiency\n * Chronic or active neurologic disease including seizure disorder\n * History of splenectomy\n * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or abnormal baseline laboratory screening tests\n\n * ALT above normal range\n * Creatinine above normal range\n * Hemoglobin below normal range\n * Platelet count below normal range\n * Total white cell count below normal\n * Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory infection without fever, i.e. Oral temperature \\< 37.5°C.\n * Hepatomegaly, right upper quadrant abdominal pain or tenderness\n * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period\n * Pregnant or lactating female\n * Suspected or known current alcohol abuse/drug abuse as obtained by history and physical examination\n * Female who is willing or intends to become pregnant during the study\n * Any history of allergic reaction or anaphylaxis to previous vaccination\n * Unwilling to allow blood samples to be stored for future use\n * Inability to make follow up visits\n * Allergy to kanamycin, nickel, or imidazole\n * Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study\n * Previous allergy to Rabies Vaccine\n * Allergy to chicken and chicken products'}, 'identificationModule': {'nctId': 'NCT02458092', 'briefTitle': 'Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': "Phase 1b Controlled Double Blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Candidate Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered Intramuscularly With Glaxo Smith Kline (GSK) Biologicals' Adjuvant AS01B", 'orgStudyIdInfo': {'id': 'A-14620.b'}, 'secondaryIdInfos': [{'id': 'WRAIR 1417', 'type': 'OTHER', 'domain': 'Walter Reed Army Institute of Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant', 'description': '50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant given intramuscularly in the deltoid muscle of the non-dominant arm.', 'interventionNames': ['Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)']}, {'type': 'EXPERIMENTAL', 'label': 'Rabies Vaccine Rabipur', 'description': 'Rabies Vaccine Rabipur given intramuscularly in the deltoid muscle of the non-dominant arm.', 'interventionNames': ['Biological: Rabipur']}], 'interventions': [{'name': 'Plasmodium falciparum Malaria Protein 010 (FMP010)', 'type': 'BIOLOGICAL', 'description': 'Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK', 'armGroupLabels': ['50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant']}, {'name': 'Rabipur', 'type': 'BIOLOGICAL', 'description': 'Rabipur is a licensed rabies vaccine.', 'armGroupLabels': ['Rabies Vaccine Rabipur']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nekoye Otsyula', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'US Army Medical Research Unit - Kenya'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Walter Reed Army Institute of Research (WRAIR)', 'class': 'FED'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}