Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-12 @ 7:35 PM
Study NCT ID:
NCT00565461
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2007-11-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LT Vaccine Patch Self-Administration Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@valneva.com', 'phone': '0043120620', 'title': 'Head Clinical Development', 'phoneExt': '0', 'organization': 'Valneva Austria GmbH'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Clinician Administered (Deltoid)', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Clinician Administered (Thigh)', 'description': '40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Self Administered (In-clinic)', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Self Administered (Non-clinic)', 'description': '40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Application site discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 29}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 39}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Application site edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Application site excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 35}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 38}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Application site scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Red blood cells in urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Brugada syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician Administered (Deltoid/ Thigh)', 'description': '1. st vaccination: administered by clinician; location: deltoid\n2. nd vaccination: administered by clinician; location: thigh'}, {'id': 'OG001', 'title': 'Self Administered (In-clinic & Non-clinic)', 'description': '1. st vaccination: administered by clinician; location: deltoid\n2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh'}], 'classes': [{'title': 'LT IgG GMTs - Day 0', 'categories': [{'measurements': [{'value': '362', 'groupId': 'OG000', 'lowerLimit': '264', 'upperLimit': '496'}, {'value': '442', 'groupId': 'OG001', 'lowerLimit': '354', 'upperLimit': '552'}]}]}, {'title': 'LT IgG GMTs - Day 14', 'categories': [{'measurements': [{'value': '1974', 'groupId': 'OG000', 'lowerLimit': '1196', 'upperLimit': '3258'}, {'value': '2896', 'groupId': 'OG001', 'lowerLimit': '2032', 'upperLimit': '4127'}]}]}, {'title': 'LT IgG GMTs - Day 21', 'categories': [{'measurements': [{'value': '4747', 'groupId': 'OG000', 'lowerLimit': '3232', 'upperLimit': '6973'}, {'value': '7545', 'groupId': 'OG001', 'lowerLimit': '5759', 'upperLimit': '9886'}]}]}, {'title': 'LT IgG GMTs - Day 28', 'categories': [{'measurements': [{'value': '11153', 'groupId': 'OG000', 'lowerLimit': '8255', 'upperLimit': '15068'}, {'value': '12180', 'groupId': 'OG001', 'lowerLimit': '9832', 'upperLimit': '15089'}]}]}, {'title': 'LT IgG GMTs - Day 35', 'categories': [{'measurements': [{'value': '12165', 'groupId': 'OG000', 'lowerLimit': '9320', 'upperLimit': '15877'}, {'value': '12745', 'groupId': 'OG001', 'lowerLimit': '10519', 'upperLimit': '15442'}]}]}, {'title': 'LT IgG GMTs - Day 194', 'categories': [{'measurements': [{'value': '4997', 'groupId': 'OG000', 'lowerLimit': '3753', 'upperLimit': '6654'}, {'value': '6035', 'groupId': 'OG001', 'lowerLimit': '4917', 'upperLimit': '7409'}]}]}, {'title': 'LT IgA GMTs - Day 0', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '69'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '44', 'upperLimit': '64'}]}]}, {'title': 'LT IgA GMTs - Day 14', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000', 'lowerLimit': '142', 'upperLimit': '335'}, {'value': '365', 'groupId': 'OG001', 'lowerLimit': '270', 'upperLimit': '494'}]}]}, {'title': 'LT IgA GMTs - Day 21', 'categories': [{'measurements': [{'value': '430', 'groupId': 'OG000', 'lowerLimit': '309', 'upperLimit': '598'}, {'value': '639', 'groupId': 'OG001', 'lowerLimit': '507', 'upperLimit': '806'}]}]}, {'title': 'LT IgA GMTs - Day 28', 'categories': [{'measurements': [{'value': '632', 'groupId': 'OG000', 'lowerLimit': '462', 'upperLimit': '864'}, {'value': '768', 'groupId': 'OG001', 'lowerLimit': '615', 'upperLimit': '960'}]}]}, {'title': 'LT IgA GMTs - Day 35', 'categories': [{'measurements': [{'value': '548', 'groupId': 'OG000', 'lowerLimit': '397', 'upperLimit': '757'}, {'value': '712', 'groupId': 'OG001', 'lowerLimit': '564', 'upperLimit': '898'}]}]}, {'title': 'LT IgA GMTs - Day 194', 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000', 'lowerLimit': '190', 'upperLimit': '341'}, {'value': '287', 'groupId': 'OG001', 'lowerLimit': '233', 'upperLimit': '354'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0, Day 14, Day 21, Day 28, Day 35, Day 194', 'description': 'The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \\[second\\] vaccination with clinician-administered \\[second\\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.\n\nGMT: geometric mean titer', 'unitOfMeasure': 'geometric mean titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology'}, {'type': 'PRIMARY', 'title': 'GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician Administered (Deltoid/ Thigh)', 'description': '1. st vaccination: administered by clinician; location: deltoid\n2. nd vaccination: administered by clinician; location: thigh'}, {'id': 'OG001', 'title': 'Self Administered (In-clinic & Non-clinic)', 'description': '1. st vaccination: administered by clinician; location: deltoid\n2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh'}], 'classes': [{'title': 'LT IgG GMFR - Day 14', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9'}]}]}, {'title': 'LT IgG GMFR - Day 21', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '20'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '23'}]}]}, {'title': 'LT IgG GMFR - Day 28', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '44'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '36'}]}]}, {'title': 'LT IgG GMFR - Day 35', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '49'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '38'}]}]}, {'title': 'LT IgG GMFR - Day 194', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '18'}]}]}, {'title': 'LT IgA GMFR - Day 14', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9'}]}]}, {'title': 'LT IgA GMFR - Day 21', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '11'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '15'}]}]}, {'title': 'LT IgA GMFR - Day 28', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '16'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '18'}]}]}, {'title': 'LT IgA GMFR - Day 35', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '15'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '17'}]}]}, {'title': 'LT IgA GMFR - Day 194', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14, Day 21, Day 28, Day 35, Day 194', 'description': 'The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \\[second\\] vaccination with clinician-administered \\[second\\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.\n\nGMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data.', 'unitOfMeasure': 'geometric mean fold ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology'}, {'type': 'PRIMARY', 'title': 'Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician Administered (Deltoid/ Thigh)', 'description': '1. st vaccination: administered by clinician; location: deltoid\n2. nd vaccination: administered by clinician; location: thigh'}, {'id': 'OG001', 'title': 'Self Administered (In-clinic & Non-clinic)', 'description': '1. st vaccination: administered by clinician; location: deltoid\n2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh'}], 'classes': [{'title': 'LT IgG SCR - Day 14', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '79'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '82'}]}]}, {'title': 'LT IgG SCR - Day 21', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '98'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'LT IgG SCR - Day 28', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '100'}]}]}, {'title': 'LT IgG SCR - Day 35', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '100'}]}]}, {'title': 'LT IgG SCR - Day 194', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'LT IgA SCR - Day 14', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '64'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '70'}]}]}, {'title': 'LT IgA SCR - Day 21', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '83'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '92'}]}]}, {'title': 'LT IgA SCR - Day 28', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '93'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '96'}]}]}, {'title': 'LT IgA SCR - Day 35', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '91'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '77', 'upperLimit': '94'}]}]}, {'title': 'LT IgA SCR - Day 194', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '83'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '73'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14, Day 21, Day 28, Day 35, Day 194', 'description': 'The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered \\[second\\] vaccination with clinician-administered \\[second\\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.\n\nseroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA', 'unitOfMeasure': 'percentage of study participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'OG001', 'title': 'Group 2', 'description': '40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'OG002', 'title': 'Group 3', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'OG003', 'title': 'Group 4', 'description': '40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}], 'classes': [{'title': 'All AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '347', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '387', 'groupId': 'OG003'}]}]}, {'title': 'Local AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}, {'value': '304', 'groupId': 'OG003'}]}]}, {'title': 'Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}, {'title': 'All Severe AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Severe Local AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Severe Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'All Related AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '334', 'groupId': 'OG003'}]}]}, {'title': 'Related Local AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}, {'value': '304', 'groupId': 'OG003'}]}]}, {'title': 'Related Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'All Serious AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Serious Local AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in the Outcome Measure Data Teble are the number of subjects with events'}, {'type': 'SECONDARY', 'title': 'Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician-administered - Group 1', 'description': '1. st vaccination: administered by clinician; location: deltoid\n2. nd vaccination: administered by clinician; location: deltoid'}, {'id': 'OG001', 'title': 'Clinician Administered (Deltoid/ Thigh) - Group 2', 'description': '1. st vaccination: administered by clinician; location: deltoid\n2. nd vaccination: administered by clinician; location: thigh'}], 'classes': [{'title': 'LT IgG Day 0 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '411', 'groupId': 'OG000', 'lowerLimit': '302', 'upperLimit': '561'}, {'value': '362', 'groupId': 'OG001', 'lowerLimit': '265', 'upperLimit': '493'}]}]}, {'title': 'LT IgG Day 14 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2176', 'groupId': 'OG000', 'lowerLimit': '1326', 'upperLimit': '3571'}, {'value': '1974', 'groupId': 'OG001', 'lowerLimit': '1203', 'upperLimit': '3240'}]}]}, {'title': 'LT IgG Day 21 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6292', 'groupId': 'OG000', 'lowerLimit': '4136', 'upperLimit': '9173'}, {'value': '4747', 'groupId': 'OG001', 'lowerLimit': '3241', 'upperLimit': '6954'}]}]}, {'title': 'LT IgG Day 28 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8895', 'groupId': 'OG000', 'lowerLimit': '6453', 'upperLimit': '12263'}, {'value': '11153', 'groupId': 'OG001', 'lowerLimit': '8090', 'upperLimit': '15375'}]}]}, {'title': 'LT IgG Day 35 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12460', 'groupId': 'OG000', 'lowerLimit': '9639', 'upperLimit': '16106'}, {'value': '12165', 'groupId': 'OG001', 'lowerLimit': '9410', 'upperLimit': '15725'}]}]}, {'title': 'LT IgG Day 194 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6694', 'groupId': 'OG000', 'lowerLimit': '5095', 'upperLimit': '8795'}, {'value': '4997', 'groupId': 'OG001', 'lowerLimit': '3790', 'upperLimit': '6589'}]}]}, {'title': 'LT IgA Day 0 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '56'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '70'}]}]}, {'title': 'LT IgA Day 14 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000', 'lowerLimit': '155', 'upperLimit': '368'}, {'value': '218', 'groupId': 'OG001', 'lowerLimit': '142', 'upperLimit': '337'}]}]}, {'title': 'LT IgA Day 21 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '502', 'groupId': 'OG000', 'lowerLimit': '358', 'upperLimit': '703'}, {'value': '430', 'groupId': 'OG001', 'lowerLimit': '306', 'upperLimit': '605'}]}]}, {'title': 'LT IgA Day 28 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '610', 'groupId': 'OG000', 'lowerLimit': '444', 'upperLimit': '839'}, {'value': '632', 'groupId': 'OG001', 'lowerLimit': '460', 'upperLimit': '869'}]}]}, {'title': 'LT IgA Day 35 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '567', 'groupId': 'OG000', 'lowerLimit': '419', 'upperLimit': '767'}, {'value': '548', 'groupId': 'OG001', 'lowerLimit': '405', 'upperLimit': '742'}]}]}, {'title': 'LT IgA Day 194 - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '272', 'groupId': 'OG000', 'lowerLimit': '206', 'upperLimit': '360'}, {'value': '254', 'groupId': 'OG001', 'lowerLimit': '192', 'upperLimit': '337'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'OG001', 'title': 'Group 4', 'description': '40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}], 'classes': [{'title': 'Erythema - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Erythema - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Rash - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Rash - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Pruiruts - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Hyperpigmentation - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Hyperpigmentation - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Edema - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Edema - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Pain - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Pain - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Fever - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Malaise - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Malaise - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Headache - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Headache - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea - 1st vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea - 2nd vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Number Analyzed in Outcome Measure Data Table: in Group 3 only 39 subjects received the second vaccination.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'OG001', 'title': 'Group 4', 'description': '40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. 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Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}], 'classes': [{'title': 'Lt IgG Day 14 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '12'}]}]}, {'title': 'LT IgG Day 21 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '21'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '31'}]}]}, {'title': 'LT IgG Day 28 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '33'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '50'}]}]}, {'title': 'LT IgG Day 35 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '37'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '49'}]}]}, {'title': 'LT IgG Day 194 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '17'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '23'}]}]}, {'title': 'LT IgA Day 14 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '12'}]}]}, {'title': 'LT IgA Day 21 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}]}]}, {'title': 'LT IgA Day 28 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '17'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '23'}]}]}, {'title': 'LT IgA Day 35 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '15'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '22'}]}]}, {'title': 'LT IgA Day 194 - GMFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'OG001', 'title': 'Group 4', 'description': '40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}], 'classes': [{'title': 'LT IgG Day 14 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '81'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '90'}]}]}, {'title': 'LT IgG Day 21 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}, {'title': 'LT IgG Day 28 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}, {'title': 'LT IgG Day 35 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '100'}]}]}, {'title': 'LT IgG Day 194 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'LT IgA Day 14 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '73'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '75'}]}]}, {'title': 'LT IgA Day 21 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '94'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '94'}]}]}, {'title': 'LT IgA Day 28 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '98'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '96'}]}]}, {'title': 'LT IgA Day 35 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '94'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '97'}]}]}, {'title': 'LT IgA Day 194 - SCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '72'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinician Administered (Deltoid)', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'FG001', 'title': 'Clinician Administered (Thigh)', 'description': '40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'FG002', 'title': 'Self Administered (In-clinic)', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'FG003', 'title': 'Self Administered (Non-clinic)', 'description': '40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinician Administered (Deltoid)', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'BG001', 'title': 'Clinician Administered (Thigh)', 'description': '40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'BG002', 'title': 'Self Administered (In-clinic)', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'BG003', 'title': 'Self Administered (Non-clinic)', 'description': '40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.\n\nheat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '12.21', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '11.10', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '11.18', 'groupId': 'BG002'}, {'value': '34.1', 'spread': '11.18', 'groupId': 'BG003'}, {'value': '36.0', 'spread': '11.02', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2007-11-28', 'resultsFirstSubmitDate': '2014-01-30', 'studyFirstSubmitQcDate': '2007-11-29', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-17', 'studyFirstPostDateStruct': {'date': '2007-11-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.', 'timeFrame': 'Day 0, Day 14, Day 21, Day 28, Day 35, Day 194', 'description': 'The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \\[second\\] vaccination with clinician-administered \\[second\\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.\n\nGMT: geometric mean titer'}, {'measure': 'GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.', 'timeFrame': 'Day 14, Day 21, Day 28, Day 35, Day 194', 'description': 'The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \\[second\\] vaccination with clinician-administered \\[second\\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.\n\nGMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data.'}, {'measure': 'Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.', 'timeFrame': 'Day 14, Day 21, Day 28, Day 35, Day 194', 'description': 'The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered \\[second\\] vaccination with clinician-administered \\[second\\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.\n\nseroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA'}], 'secondaryOutcomes': [{'measure': 'Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch', 'timeFrame': '6 months'}, {'measure': 'Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.', 'timeFrame': '6 months'}, {'measure': 'Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.', 'timeFrame': '6 months'}, {'measure': 'Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.', 'timeFrame': '6 months'}, {'measure': 'Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine', 'timeFrame': '6 months'}, {'measure': 'Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine', 'timeFrame': '6 months'}, {'measure': 'Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic', 'timeFrame': '6 months'}, {'measure': 'Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Prevention of Travelers' Diarrhea"]}, 'descriptionModule': {'briefSummary': 'To evaluate the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible to participate in the study:\n\n* Healthy adult males or females 18-64 years of age with signed Informed Consent.\n* Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria are not eligible for participation in the study:\n\n* Laboratory abnormalities \\[as determined by the Toxicity Grading Scale (grade 1-4)\\] at laboratory screening\n* Abnormalities at physical examination \\[as determined by the Toxicity Grading Scale (grade 1-4)\\]\n* Known allergies to any component of the vaccine\n* Known allergies to adhesives\n* Participated in research involving investigational product within 30 days before planned date of first vaccination\n* Donated blood or blood products such as plasma within the past 30 days\n* Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd\n* Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™)\n* History of traveler's diarrhea in the previous two years\n* History of abdominal surgery (excluding C-Section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal (GI) illness\n* Positive serology for HIV-1, HIV-2, HBsAg, or HCV\n* Medical history of acute or chronic skin disease at vaccination area(s)\n* Active skin allergy\n* Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation\n* Excessively hirsute at the vaccination area(s) that would interfere with patch adhesion in the opinion of the Investigator\n* Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)\n* Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination\n* Women who are pregnant or breastfeeding\n* Acute illness at screening or at baseline; or\n* Employee of the investigational site."}, 'identificationModule': {'nctId': 'NCT00565461', 'briefTitle': 'LT Vaccine Patch Self-Administration Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intercell USA, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Open-Label Study to Compare the Immunogenicity and Safety of a Self-Administered LT Vaccine Patch With an LT Vaccine Patch Administered by a Clinician', 'orgStudyIdInfo': {'id': 'ELT203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician', 'interventionNames': ['Biological: heat-labile enterotoxin of E. coli (LT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.', 'interventionNames': ['Biological: heat-labile enterotoxin of E. coli (LT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': '40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.', 'interventionNames': ['Biological: heat-labile enterotoxin of E. coli (LT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': '40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.', 'interventionNames': ['Biological: heat-labile enterotoxin of E. coli (LT)']}], 'interventions': [{'name': 'heat-labile enterotoxin of E. coli (LT)', 'type': 'BIOLOGICAL', 'otherNames': ['TD Vaccine System'], 'description': '37.5ug patch applied on either the deltoid or the thigh', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Medical Research Testing', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Judith Forte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arkansas Medical Research Testing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intercell USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}