Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT00287469
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2006-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D016751', 'term': 'Hepatitis E'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shrestham@afrims.org', 'phone': '662-644-4888', 'title': 'Mrigendra P. Shrestha MD', 'organization': 'Armed Forces Research Institute of Medical Services'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Within 31 days (days 0-30) post-vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.\n\nPlacebo: PBS buffer placebo containing alum', 'otherNumAtRisk': 1000, 'deathsNumAtRisk': 1000, 'otherNumAffected': 226, 'seriousNumAtRisk': 1000, 'deathsNumAffected': 1, 'seriousNumAffected': 200}, {'id': 'EG001', 'title': '20mcg Recombinant HEV', 'description': '20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule\n\nHepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)', 'otherNumAtRisk': 1000, 'deathsNumAtRisk': 1000, 'otherNumAffected': 229, 'seriousNumAtRisk': 1000, 'deathsNumAffected': 6, 'seriousNumAffected': 143}], 'otherEvents': [{'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Astigmatism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pericoronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Salivary gland mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tooth disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Feeling of body temperature change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Jaundice hepatocellular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ascariasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Encephalitis japanese b', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis shigella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Giardiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gingival infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Helminthic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hepatitis e', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Leptospirosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Paratyphoid fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 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'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anal fistula excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhoid operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vasectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '1000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mcg Recombinant HEV', 'description': '20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule\n\nHepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.\n\nPlacebo: PBS buffer placebo containing alum'}], 'classes': [{'title': 'Jaundice; IgM ≥ 100 WR U/mL', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '8.8'}]}]}, {'title': 'Jaundice; total lg ≥ 2500 WR U/mL', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.0'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}]}]}, {'title': 'Jaundice; IgM≥100 WR U/mL or total lg≥2500 WR U/mL', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '8.9'}]}]}, {'title': 'Illness; IgM ≥ 100 WR U/mL', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '1.0'}]}]}, {'title': 'Illness; total lg ≥ 2500 WR U/mL', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Illness; IgM≥100 WR U/mL or total lg≥2500 WR U/mL', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '1.0'}]}]}, {'title': 'Jaun/Ill; IgM≥100 WR U/mL or total lg≥2500 WR U/mL', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.0'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '9.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days after dose 3 at 6 months', 'description': 'Percent of participants of definite hepatitis E by category and immunological markers (anti HEV) during the follow-up period.\n\n* Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting\n* Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105)\n* Percent of Participants = n x 100 / N', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '1000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mcg Recombinant HEV', 'description': '20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule\n\nHepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.\n\nPlacebo: PBS buffer placebo containing alum'}], 'classes': [{'title': 'Jaundice; IgM ≥ 100 WR U/ml', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.6'}]}]}, {'title': 'Jaundice; total Ig ≥ 2500 WR U/ml', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Jaundice; IgM≥100 WR U/mL or total lg≥2500 WR U/mL', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.6'}]}]}, {'title': 'Illness; ImG ≥ 100 WR U/ml', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Illness; total Ig ≥ 2500 WR U/ml', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Jaun/Ill; IgM≥100 WR U/mL or total lg≥2500 WR U/mL', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days after dose 2 until 14 days after dose 3', 'description': 'Percent of participants of definite hepatitis E and vaccine efficacy by category during the follow-up period\n\n* Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting\n* Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105)\n* Percent of participants = n x 100 / N', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '1000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.\n\nPlacebo: PBS buffer placebo containing alum'}, {'id': 'OG001', 'title': '20mcg Recombinant HEV', 'description': '20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule\n\nHepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)'}], 'classes': [{'title': 'Any acute hep cases: before dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any hep cases: within 14 days after dose 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any hep cases: between 14 days after dose 1 and 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any hep cases: within 14 days after dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any hep cases: between 14 days after dose 2 and 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any hep cases: within 14 days after dose 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any hep cases: from 14 days after dose 3', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Any hep cases: Total', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Definite hepE cases: before dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Definite hepE cases: within 14 days after dose 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Definite hepE cases: btwn 14dys after dose 1 and 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Definite hepE cases: within 14 days after dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Definite hepE cases: btwn 14dys after dose 2 and 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Definite hepE cases: within 14 days after dose 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Definite hepE cases: from 14 days after dose 3', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Definate hepE cases: Total', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Probable hepE cases', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not confirmed hepE: before dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not confirmed hepE: within 14 days after dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not confirmed hepE: btwn 14dys after dose 1 and 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not confirmed hepE: within 14 days after dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not confirmed hepE: btwn 14dys after dose 2 and 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Not confirmed hepE: within 14 days after dose 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not confirmed hepE: from 14 days after dose 3', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Not confirmed hepE: total', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'before dose 1 thru 14 days after dose 3', 'description': 'Number of suspected, definite, probable and not confirmed hepatitis E disease cases during surveillance period', 'unitOfMeasure': 'Number of Hepatitis E Cases', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.\n\nPlacebo: PBS buffer placebo containing alum'}, {'id': 'FG001', 'title': '20mcg Recombinant HEV', 'description': '20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule\n\nHepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1000'}, {'groupId': 'FG001', 'numSubjects': '1000'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '780'}, {'groupId': 'FG001', 'numSubjects': '786'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '214'}]}], 'dropWithdraws': [{'type': 'serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'moved from area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '69'}]}]}], 'recruitmentDetails': '2000 subject were recruited by Royal Nepalese Army investigators at the Shree Birendra Hospital, Kathmandu from a well characterized population of Royal Nepalese Army military personnel stationed in the Kathmandu Valley and their family members and up to 5 US citizens residing in the Nepal.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'BG000'}, {'value': '1000', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.\n\nPlacebo: PBS buffer placebo containing alum'}, {'id': 'BG001', 'title': '20mcg Recombinant HEV', 'description': '20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule\n\nHepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.3', 'spread': '12.69', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '8.29', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '10.07', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'BG000'}, {'value': '996', 'groupId': 'BG001'}, {'value': '1992', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '6.12', 'groupId': 'BG000'}, {'value': '25.2', 'spread': '6.34', 'groupId': 'BG001'}, {'value': '25.2', 'spread': '6.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Male and Female participants add up to the total number for each group: Placebo (1000) and 20mcg Recombinant HEV (1000).'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'BG000'}, {'value': '1000', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '996', 'groupId': 'BG000'}, {'value': '996', 'groupId': 'BG001'}, {'value': '1992', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Nepal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'BG000'}, {'value': '1000', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1000', 'groupId': 'BG000'}, {'value': '1000', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-08', 'studyFirstSubmitDate': '2006-02-02', 'resultsFirstSubmitDate': '2018-10-09', 'studyFirstSubmitQcDate': '2006-02-02', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-08', 'studyFirstPostDateStruct': {'date': '2006-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2004-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period', 'timeFrame': '14 days after dose 3 at 6 months', 'description': 'Percent of participants of definite hepatitis E by category and immunological markers (anti HEV) during the follow-up period.\n\n* Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting\n* Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105)\n* Percent of Participants = n x 100 / N'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period', 'timeFrame': '14 days after dose 2 until 14 days after dose 3', 'description': 'Percent of participants of definite hepatitis E and vaccine efficacy by category during the follow-up period\n\n* Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting\n* Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105)\n* Percent of participants = n x 100 / N'}, {'measure': 'Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases', 'timeFrame': 'before dose 1 thru 14 days after dose 3', 'description': 'Number of suspected, definite, probable and not confirmed hepatitis E disease cases during surveillance period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis E', 'clinical hepatitis', 'vaccine', 'efficacy', 'Nepal'], 'conditions': ['Hepatitis']}, 'referencesModule': {'references': [{'pmid': '12602109', 'type': 'BACKGROUND', 'citation': 'Worm HC, Schlauder GG, Brandstatter G. Hepatitis E and its emergence in non-endemic areas. Wien Klin Wochenschr. 2002 Aug 30;114(15-16):663-70.'}, {'pmid': '12048035', 'type': 'BACKGROUND', 'citation': 'Worm HC, van der Poel WH, Brandstatter G. Hepatitis E: an overview. Microbes Infect. 2002 May;4(6):657-66. doi: 10.1016/s1286-4579(02)01584-8.'}, {'pmid': '15575050', 'type': 'BACKGROUND', 'citation': 'Emerson SU, Purcell RH. Running like water--the omnipresence of hepatitis E. N Engl J Med. 2004 Dec 2;351(23):2367-8. doi: 10.1056/NEJMp048285. No abstract available.'}, {'pmid': '8146130', 'type': 'BACKGROUND', 'citation': 'Purcell RH. Hepatitis viruses: changing patterns of human disease. Proc Natl Acad Sci U S A. 1994 Mar 29;91(7):2401-6. doi: 10.1073/pnas.91.7.2401.'}, {'pmid': '15233590', 'type': 'BACKGROUND', 'citation': 'Worm HC, Wirnsberger G. Hepatitis E vaccines: progress and prospects. Drugs. 2004;64(14):1517-31. doi: 10.2165/00003495-200464140-00002.'}, {'pmid': '17329696', 'type': 'DERIVED', 'citation': 'Shrestha MP, Scott RM, Joshi DM, Mammen MP Jr, Thapa GB, Thapa N, Myint KS, Fourneau M, Kuschner RA, Shrestha SK, David MP, Seriwatana J, Vaughn DW, Safary A, Endy TP, Innis BL. Safety and efficacy of a recombinant hepatitis E vaccine. N Engl J Med. 2007 Mar 1;356(9):895-903. doi: 10.1056/NEJMoa061847.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a hepatitis E vaccine is safe and able to prevent symptomatic liver disease due to the hepatitis E virus.', 'detailedDescription': 'This is a prospective, randomized, double-blind, placebo-controlled with 2 study groups (vaccine and placebo). Three doses of the study vaccine are given according to a 0, 1, 6 month schedule. Vaccine efficacy will be assessed by maintaining active surveillance for clinical hepatitis every 2 weeks and hospital based surveillance for the full duration of the trial. Total planned study population is 2000 eligible subjects (1000 in the vaccine group and 1000 in the placebo group). Total vaccinated cohort for the analysis of reactogenicity is 200 (100 in the vaccine group and 100 in the placebo group).\n\nVolunteers who enroll will be followed for evidence of symptomatic liver disease for approximately 2 years, and those who become ill will be admitted to hospital for care.\n\nTo evaluate safety, a randomly designated subset will be monitored for 7 days after each vaccination to solicit specific symptoms at the injection site and generally. Additionally, all adverse events will be collected for 30 days after each vaccine dose and all serious adverse events will be collected throughout the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female 18 years of age or older at the time of the first vaccination.\n* Written or oral witnessed (if the subject was illiterate) informed consent obtained from the subject\n* Free of obvious health problems as established by medical history before entering into the study\n* If the subject was female, she must have a negative serum pregnancy test within 48 hours prior to each vaccination and must agree to avoid becoming pregnant during the course of vaccination and until 30 days after the last dose of vaccine.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) 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 will mean prednisone, or equivalent, \\* 0.5 mg/kg/day. Inhaled and topical steroids are allowed.\n* Any chronic drug therapy to be continued during the study period with the exception of contraceptive agents, homeopathic remedies, vitamins, minerals and any other dietary supplements or other drug therapy at the discretion of the investigator.\n* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, excluding tetanus toxoid or rabies vaccine.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, as reported by the volunteer (testing for HIV will not be performed).\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Major congenital defects or serious chronic illness.\n* History of any neurologic disorders or seizures.\n* Acute disease at the time of enrollment. Acute disease was defined as the presence of a moderate or severe illness with or without fever. All vaccines could be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature \\< 38.0°C (100.4°F).\n* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history.\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 female.\n* History of chronic alcohol consumption (defined as the consumption of the equivalent of 4 or more 12 ounce beers 4 or more times a week) and/or intravenous drug abuse.\n* Antibodies to rHEV (\\* 20 WR U/mL).'}, 'identificationModule': {'nctId': 'NCT00287469', 'briefTitle': 'A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'A Phase II, Prospective, Randomized, Double-blind, Placebo Controlled, Field Efficacy Trial of a Candidate Hepatitis E Vaccine in Nepal.', 'orgStudyIdInfo': {'id': 'WRAIR 749'}, 'secondaryIdInfos': [{'id': 'HSRRB A-9117.1'}, {'id': 'GSK 304558/003 (HEV-003)'}, {'id': 'IND 7815', 'type': 'OTHER', 'domain': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20mcg Recombinant HEV', 'description': '20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule', 'interventionNames': ['Biological: Hepatitis E vaccine, recombinant (Sar 56 kDa)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Hepatitis E vaccine, recombinant (Sar 56 kDa)', 'type': 'BIOLOGICAL', 'description': '20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)', 'armGroupLabels': ['20mcg Recombinant HEV']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'PBS buffer placebo containing alum', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kathmandu', 'country': 'Nepal', 'facility': 'Shree Birendra Hospital', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}], 'overallOfficials': [{'name': 'Mrigendra P Shrestha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Armed Forces Research Institute of Medical Sciences, Thailand'}, {'name': 'Robert M Scott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter Reed Army Institute of Research (WRAIR)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}