Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-02 @ 10:56 AM
Study NCT ID:
NCT00414050
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2006-12-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland', 'Norway']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017325', 'term': 'Hepatitis B Vaccines'}, {'id': 'C075655', 'term': 'Recombivax HB'}, {'id': 'C075654', 'term': 'Engerix-B'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1 800 672 6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination', 'description': 'All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.', 'eventGroups': [{'id': 'EG000', 'title': 'Modified Process Hepatitis B Vaccine 5 µg (Micrograms)', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.', 'otherNumAtRisk': 430, 'otherNumAffected': 308, 'seriousNumAtRisk': 430, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'RECOMBIVAX™ Hepatitis B Vaccine', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.', 'otherNumAtRisk': 424, 'otherNumAffected': 294, 'seriousNumAtRisk': 424, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Modified Process Hepatitis B Vaccine 10 µg', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.', 'otherNumAtRisk': 429, 'otherNumAffected': 276, 'seriousNumAtRisk': 429, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'ENGERIX-B®', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.', 'otherNumAtRisk': 428, 'otherNumAffected': 288, 'seriousNumAtRisk': 428, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 169, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 157, 'numAffected': 109}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 138, 'numAffected': 91}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 139, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 78, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 65, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 68, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 65, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Injection-site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 169, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 160, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 153, 'numAffected': 116}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 124, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Injection-site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 117, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 96, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 90, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 92, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Injection-site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Injection-site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 109, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 111, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 110, 'numAffected': 87}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 98, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 51, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 49, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 48, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 48, 'numAffected': 41}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 37, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 36, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 26, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 57, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 54, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 68, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 57, 'numAffected': 51}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Nutritional condition abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sudden infant death syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}, {'value': '400', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Process Hepatitis B Vaccine 5 µg (Micrograms)', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'OG001', 'title': 'RECOMBIVAX™ Hepatitis B Vaccine', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'OG002', 'title': 'Modified Process Hepatitis B Vaccine 10 µg', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'OG003', 'title': 'ENGERIX-B®', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.8'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '99.9', 'upperLimit': '100'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '98.7', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 months of age (1 month after 3 doses)', 'description': 'The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.'}, {'type': 'SECONDARY', 'title': 'Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}, {'value': '400', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Process Hepatitis B Vaccine 5 µg (Micrograms)', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'OG001', 'title': 'RECOMBIVAX™ Hepatitis B Vaccine', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'OG002', 'title': 'Modified Process Hepatitis B Vaccine 10 µg', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'OG003', 'title': 'ENGERIX-B®', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '748.2', 'groupId': 'OG000', 'lowerLimit': '672.0', 'upperLimit': '833.1'}, {'value': '376.8', 'groupId': 'OG001', 'lowerLimit': '331.4', 'upperLimit': '428.5'}, {'value': '981.5', 'groupId': 'OG002', 'lowerLimit': '891.0', 'upperLimit': '1081.2'}, {'value': '556.6', 'groupId': 'OG003', 'lowerLimit': '491.8', 'upperLimit': '629.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '1.69', 'ciUpperLimit': '2.35', 'groupDescription': 'Comparison of Induced (effected) Geometric Mean Titer for the Modified Hepatitis B Process Vaccine and RECOMBIVAX Hepatitis B vaccine.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Modified Process Hepatitis B vaccine-5µg (micrograms) declared non-inferior to RECOMBIVAX HB™ if the lower bound of the 95% Confidence Interval for the ratio of Geometric Mean Titers (Modified Process Vaccine 5 micrograms/RECOMBIVAX HB™) was \\>= 0.67. The study had 98 percent power for this test, based on an assumption of true equality.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '7 months of age (1 month after 3 doses)', 'description': 'Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Modified Process Hepatitis B Vaccine 5 µg (Micrograms)', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'FG001', 'title': 'RECOMBIVAX™ Hepatitis B Vaccine', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'FG002', 'title': 'Modified Process Hepatitis B Vaccine 10 µg', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'FG003', 'title': 'ENGERIX-B®', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '431'}, {'groupId': 'FG001', 'numSubjects': '427'}, {'groupId': 'FG002', 'numSubjects': '429'}, {'groupId': 'FG003', 'numSubjects': '431'}]}, {'type': 'Received Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '431'}, {'groupId': 'FG001', 'numSubjects': '426'}, {'groupId': 'FG002', 'numSubjects': '429'}, {'groupId': 'FG003', 'numSubjects': '431'}]}, {'type': 'Received Vaccination 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '425'}, {'groupId': 'FG001', 'numSubjects': '421'}, {'groupId': 'FG002', 'numSubjects': '425'}, {'groupId': 'FG003', 'numSubjects': '425'}]}, {'type': 'Received Vaccination 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '424'}, {'groupId': 'FG001', 'numSubjects': '419'}, {'groupId': 'FG002', 'numSubjects': '425'}, {'groupId': 'FG003', 'numSubjects': '424'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '422'}, {'groupId': 'FG001', 'numSubjects': '419'}, {'groupId': 'FG002', 'numSubjects': '423'}, {'groupId': 'FG003', 'numSubjects': '423'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Subject discontinued for other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Subject Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '15-Nov-2006 (First Participant Enrolled in Study) to 24-Oct-2007 (Last Participant had their Last Visit). Last participant completed follow-up: 16-Oct-2007.This study was conducted at 15 sites; 14 in Finland and 1 in Norway.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'BG000'}, {'value': '427', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}, {'value': '431', 'groupId': 'BG003'}, {'value': '1718', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Modified Process Hepatitis B Vaccine 5 µg (Micrograms)', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'BG001', 'title': 'RECOMBIVAX™ Hepatitis B Vaccine', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'BG002', 'title': 'Modified Process Hepatitis B Vaccine 10 µg', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'BG003', 'title': 'ENGERIX-B®', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '10.18', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '10.15', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '9.83', 'groupId': 'BG002'}, {'value': '62.8', 'spread': '9.81', 'groupId': 'BG003'}, {'value': '63.1', 'spread': '9.99', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}, {'value': '816', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '902', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1718}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2007-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2006-12-20', 'resultsFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2006-12-20', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-10', 'studyFirstPostDateStruct': {'date': '2006-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®', 'timeFrame': '7 months of age (1 month after 3 doses)', 'description': 'The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.'}], 'secondaryOutcomes': [{'measure': 'Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®', 'timeFrame': '7 months of age (1 month after 3 doses)', 'description': 'Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '21552183', 'type': 'RESULT', 'citation': 'Vesikari T, Martin JC, Liss CL, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. Pediatr Infect Dis J. 2011 Jul;30(7):e109-13. doi: 10.1097/INF.0b013e31821ed1a4.'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is a healthy infant approximately 2 months of age\n\nExclusion Criteria:\n\n* Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant\n* Participant's birth mother did not receive any prenatal care\n* Participant has previous history of hepatitis B infection\n* Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant\n* Participant has had a fever within 72 hours of study start\n* Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant"}, 'identificationModule': {'nctId': 'NCT00414050', 'briefTitle': 'A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age', 'orgStudyIdInfo': {'id': 'V232-057'}, 'secondaryIdInfos': [{'id': '2006_053'}, {'id': '2006-001638-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Process Hepatitis B vaccine 5 μg', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.', 'interventionNames': ['Biological: Modified Process Hepatitis B Vaccine (Experimental)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RECOMBIVAX HB™ Hepatitis B Vaccine', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.', 'interventionNames': ['Biological: Hepatitis B Vaccine (Recombinant)']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Process Hepatitis B vaccine 10 μg', 'description': 'Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.', 'interventionNames': ['Biological: Modified Process Hepatitis B Vaccine (Experimental)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ENGERIX-B®', 'description': 'Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.', 'interventionNames': ['Biological: Hepatitis B Vaccine (Recombinant)']}], 'interventions': [{'name': 'Modified Process Hepatitis B Vaccine (Experimental)', 'type': 'BIOLOGICAL', 'description': 'Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).', 'armGroupLabels': ['Modified Process Hepatitis B vaccine 10 μg', 'Modified Process Hepatitis B vaccine 5 μg']}, {'name': 'Hepatitis B Vaccine (Recombinant)', 'type': 'BIOLOGICAL', 'otherNames': ['RECOMBIVAX HB™'], 'description': 'RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.', 'armGroupLabels': ['RECOMBIVAX HB™ Hepatitis B Vaccine']}, {'name': 'Hepatitis B Vaccine (Recombinant)', 'type': 'BIOLOGICAL', 'otherNames': ['ENGERIX-B®'], 'description': 'ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months', 'armGroupLabels': ['ENGERIX-B®']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}