Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-21 @ 9:05 AM
Study NCT ID:
NCT03145766
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2017-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of a Purified Vero Rabies Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).', 'description': 'Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 40, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 39, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 45, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 22, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 28, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application Site Bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 69, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 60, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 95, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 30, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 56, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 41, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 35, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 35, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 49, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 36, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 41, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 44, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'notes': 'Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 49, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 42, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 41, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Facial Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.101', 'groupId': 'OG000', 'lowerLimit': '0.099', 'upperLimit': '0.102'}, {'value': '0.100', 'comment': 'Upper and lower limit of 95% confidence interval (CI) was not estimable because all the participants had same value and no variability was observed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.102', 'groupId': 'OG002', 'lowerLimit': '0.099', 'upperLimit': '0.104'}, {'value': '0.101', 'groupId': 'OG003', 'lowerLimit': '0.099', 'upperLimit': '0.103'}, {'value': '0.100', 'comment': 'Upper and lower limit of 95% CI was not estimable because all the participants had same value and no variability was observed.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0', 'description': 'RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method.', 'unitOfMeasure': 'international units per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Analysis Set (PPAS): participants who received at least one dose of the study vaccine without protocol deviations before Day 14 (i.e., 7 days after the 3rd vaccine injection).'}, {'type': 'PRIMARY', 'title': 'Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'groupId': 'OG000', 'lowerLimit': '0.944', 'upperLimit': '1.73'}, {'value': '1.79', 'groupId': 'OG001', 'lowerLimit': '1.33', 'upperLimit': '2.41'}, {'value': '2.52', 'groupId': 'OG002', 'lowerLimit': '1.93', 'upperLimit': '3.28'}, {'value': '1.38', 'groupId': 'OG003', 'lowerLimit': '0.936', 'upperLimit': '2.05'}, {'value': '1.56', 'groupId': 'OG004', 'lowerLimit': '1.06', 'upperLimit': '2.29'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14', 'description': 'RVNA GMT against rabies virus was assessed using the RFFIT assay method.', 'unitOfMeasure': 'international units per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS.'}, {'type': 'PRIMARY', 'title': 'Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.22', 'groupId': 'OG000', 'lowerLimit': '2.48', 'upperLimit': '4.17'}, {'value': '4.64', 'groupId': 'OG001', 'lowerLimit': '3.53', 'upperLimit': '6.10'}, {'value': '6.81', 'groupId': 'OG002', 'lowerLimit': '5.52', 'upperLimit': '8.39'}, {'value': '3.04', 'groupId': 'OG003', 'lowerLimit': '1.86', 'upperLimit': '4.95'}, {'value': '4.86', 'groupId': 'OG004', 'lowerLimit': '3.56', 'upperLimit': '6.65'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28', 'description': 'RVNA GMT against rabies virus was assessed using the RFFIT assay method.', 'unitOfMeasure': 'international units per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.14', 'groupId': 'OG000', 'lowerLimit': '6.60', 'upperLimit': '10.0'}, {'value': '9.68', 'groupId': 'OG001', 'lowerLimit': '7.50', 'upperLimit': '12.5'}, {'value': '15.6', 'groupId': 'OG002', 'lowerLimit': '12.7', 'upperLimit': '19.1'}, {'value': '6.98', 'groupId': 'OG003', 'lowerLimit': '4.69', 'upperLimit': '10.4'}, {'value': '8.99', 'groupId': 'OG004', 'lowerLimit': '6.48', 'upperLimit': '12.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 42', 'description': 'RVNA GMT against rabies virus was assessed using the RFFIT assay method.', 'unitOfMeasure': 'international units per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.894', 'groupId': 'OG000', 'lowerLimit': '0.667', 'upperLimit': '1.20'}, {'value': '0.971', 'groupId': 'OG001', 'lowerLimit': '0.768', 'upperLimit': '1.23'}, {'value': '1.58', 'groupId': 'OG002', 'lowerLimit': '1.28', 'upperLimit': '1.94'}, {'value': '0.939', 'groupId': 'OG003', 'lowerLimit': '0.634', 'upperLimit': '1.39'}, {'value': '1.01', 'groupId': 'OG004', 'lowerLimit': '0.649', 'upperLimit': '1.58'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Month 7', 'description': 'RVNA GMT against rabies virus was assessed using the RFFIT assay method.', 'unitOfMeasure': 'international units per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'title': 'RVNA titer >= 0.2 IU/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10.0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10.3'}]}]}, {'title': 'RVNA titer >= 0.5 IU/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10.0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>=0.2 IU/mL were considered as seropositive.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'title': 'RVNA titer >= 0.2 IU/mL', 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '84.5', 'upperLimit': '97.7'}, {'value': '96.0', 'groupId': 'OG001', 'lowerLimit': '88.8', 'upperLimit': '99.2'}, {'value': '97.2', 'groupId': 'OG002', 'lowerLimit': '90.2', 'upperLimit': '99.7'}, {'value': '97.1', 'groupId': 'OG003', 'lowerLimit': '85.1', 'upperLimit': '99.9'}, {'value': '97.1', 'groupId': 'OG004', 'lowerLimit': '84.7', 'upperLimit': '99.9'}]}]}, {'title': 'RVNA titer >= 0.5 IU/mL', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '63.4', 'upperLimit': '84.5'}, {'value': '81.3', 'groupId': 'OG001', 'lowerLimit': '70.7', 'upperLimit': '89.4'}, {'value': '90.1', 'groupId': 'OG002', 'lowerLimit': '80.7', 'upperLimit': '95.9'}, {'value': '80.0', 'groupId': 'OG003', 'lowerLimit': '63.1', 'upperLimit': '91.6'}, {'value': '88.2', 'groupId': 'OG004', 'lowerLimit': '72.5', 'upperLimit': '96.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>=0.2 IU/mL were considered as seropositive.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'title': 'RVNA titers >= 0.2 IU/mL', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '91.8', 'upperLimit': '100'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '92.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94.7', 'upperLimit': '100'}, {'value': '96.6', 'groupId': 'OG003', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '89.4', 'upperLimit': '100'}]}]}, {'title': 'RVNA titers >= 0.5 IU/mL', 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '98.3'}, {'value': '95.9', 'groupId': 'OG001', 'lowerLimit': '88.5', 'upperLimit': '99.1'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94.7', 'upperLimit': '100'}, {'value': '86.2', 'groupId': 'OG003', 'lowerLimit': '68.3', 'upperLimit': '96.1'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '89.4', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>=0.2 IU/mL were considered as seropositive.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'title': 'RVNA titers >= 0.2 IU/mL', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94.8', 'upperLimit': '100'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '92.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94.5', 'upperLimit': '100'}, {'value': '96.7', 'groupId': 'OG003', 'lowerLimit': '82.8', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100'}]}]}, {'title': 'RVNA titers >= 0.5 IU/mL', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94.8', 'upperLimit': '100'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '92.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94.5', 'upperLimit': '100'}, {'value': '96.7', 'groupId': 'OG003', 'lowerLimit': '82.8', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>=0.2 IU/mL were considered as seropositive.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'title': 'RVNA titers >= 0.2 IU/mL', 'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000', 'lowerLimit': '84.1', 'upperLimit': '98.2'}, {'value': '93.0', 'groupId': 'OG001', 'lowerLimit': '84.3', 'upperLimit': '97.7'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94.4', 'upperLimit': '100'}, {'value': '92.6', 'groupId': 'OG003', 'lowerLimit': '75.7', 'upperLimit': '99.1'}, {'value': '87.1', 'groupId': 'OG004', 'lowerLimit': '70.2', 'upperLimit': '96.4'}]}]}, {'title': 'RVNA titers >= 0.5 IU/mL', 'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000', 'lowerLimit': '57.4', 'upperLimit': '81.5'}, {'value': '77.5', 'groupId': 'OG001', 'lowerLimit': '66.0', 'upperLimit': '86.5'}, {'value': '92.2', 'groupId': 'OG002', 'lowerLimit': '82.7', 'upperLimit': '97.4'}, {'value': '74.1', 'groupId': 'OG003', 'lowerLimit': '53.7', 'upperLimit': '88.9'}, {'value': '74.2', 'groupId': 'OG004', 'lowerLimit': '55.4', 'upperLimit': '88.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>= 0.2 IU/mL were considered as seropositive.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '9.37', 'upperLimit': '17.1'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '24.1'}, {'value': '24.8', 'groupId': 'OG002', 'lowerLimit': '19.0', 'upperLimit': '32.3'}, {'value': '13.7', 'groupId': 'OG003', 'lowerLimit': '9.27', 'upperLimit': '20.3'}, {'value': '15.6', 'groupId': 'OG004', 'lowerLimit': '10.6', 'upperLimit': '22.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-dose) and Day 14 (7 days post-dose 3)', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 7 days post 3rd vaccination (i.e., on Day 14) and pre-vaccination on Day 0.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '24.6', 'upperLimit': '41.3'}, {'value': '46.4', 'groupId': 'OG001', 'lowerLimit': '35.3', 'upperLimit': '61.0'}, {'value': '67.0', 'groupId': 'OG002', 'lowerLimit': '54.4', 'upperLimit': '82.6'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '18.5', 'upperLimit': '48.7'}, {'value': '48.6', 'groupId': 'OG004', 'lowerLimit': '35.6', 'upperLimit': '66.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-dose) and Day 28 (14 days post-dose 4)', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 4th vaccination (i.e., on Day 28) and pre-vaccination on Day 0.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.7', 'groupId': 'OG000', 'lowerLimit': '65.6', 'upperLimit': '99.3'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '125'}, {'value': '153', 'groupId': 'OG002', 'lowerLimit': '125', 'upperLimit': '188'}, {'value': '69.0', 'groupId': 'OG003', 'lowerLimit': '46.4', 'upperLimit': '103'}, {'value': '89.9', 'groupId': 'OG004', 'lowerLimit': '64.8', 'upperLimit': '125'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (Pre-dose) and Day 42 (14 days Post-dose 5)', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 5th vaccination (i.e., on Day 42) and pre-vaccination on Day 0.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.86', 'groupId': 'OG000', 'lowerLimit': '6.66', 'upperLimit': '11.8'}, {'value': '9.71', 'groupId': 'OG001', 'lowerLimit': '7.68', 'upperLimit': '12.3'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '19.0'}, {'value': '9.27', 'groupId': 'OG003', 'lowerLimit': '6.26', 'upperLimit': '13.7'}, {'value': '10.1', 'groupId': 'OG004', 'lowerLimit': '6.49', 'upperLimit': '15.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (Pre-dose) and Month 7 (6 Months Post Last Vaccination)', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 6 month post last vaccination on Month 7 and pre-vaccination on Day 0.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000', 'lowerLimit': '68.0', 'upperLimit': '87.8'}, {'value': '89.3', 'groupId': 'OG001', 'lowerLimit': '80.1', 'upperLimit': '95.3'}, {'value': '93.0', 'groupId': 'OG002', 'lowerLimit': '84.3', 'upperLimit': '97.7'}, {'value': '82.9', 'groupId': 'OG003', 'lowerLimit': '66.4', 'upperLimit': '93.4'}, {'value': '85.3', 'groupId': 'OG004', 'lowerLimit': '68.9', 'upperLimit': '95.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '97.6'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '86.7', 'upperLimit': '98.5'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '92.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '89.1', 'upperLimit': '100'}, {'value': '93.9', 'groupId': 'OG004', 'lowerLimit': '79.8', 'upperLimit': '99.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '99.6'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '84.9', 'upperLimit': '97.8'}, {'value': '94.1', 'groupId': 'OG002', 'lowerLimit': '85.6', 'upperLimit': '98.4'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '88.8', 'upperLimit': '100'}, {'value': '93.9', 'groupId': 'OG004', 'lowerLimit': '79.8', 'upperLimit': '99.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '99.0'}, {'value': '88.7', 'groupId': 'OG001', 'lowerLimit': '79.0', 'upperLimit': '95.0'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94.5', 'upperLimit': '100'}, {'value': '85.2', 'groupId': 'OG003', 'lowerLimit': '66.3', 'upperLimit': '95.8'}, {'value': '93.5', 'groupId': 'OG004', 'lowerLimit': '78.6', 'upperLimit': '99.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Immediate Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'title': 'Immediate Unsolicited AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Immediate Unsolicited AR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 Minutes After any Vaccination', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set (SafAS) that included participant who had received at least one least one dose of the study vaccine and were analyzed according to the actual treatment received. 1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Solicited Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'title': 'Pain post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}]}, {'title': 'Pain Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Pain Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Pain Post-vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Pain Post-vaccination 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Pain Post-vaccination 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Erythema post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Erythema Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Erythema Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Erythema Post-vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Erythema Post-vaccination 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Erythema Post-vaccination 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Swelling post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Swelling Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Swelling Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Swelling Post-vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Swelling Post-vaccination 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Swelling Post-vaccination 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5)', 'description': 'A solicited reaction (SR) was an AR observed and reported under conditions (symptoms and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included pain, erythema and swelling at and around the injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis performed on SafAS. Here, 'number analyzed' = participants with available data for each specified category.1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis. At Vaccination 2, 1 participant of Group 1 received Group 2 vaccine and thus counted in Group 2 for post-vaccination 2 safety analysis."}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Solicited Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'title': 'Fever Post-any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Fever Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Fever Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Fever Post-vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Fever Post-vaccination 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Fever Post-vaccination 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Headache Post-any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'Headache Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Headache Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Headache Post-vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Headache Post-vaccination 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Headache Post-vaccination 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Malaise Post-any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Malaise Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Malaise Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Malaise Post-vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Malaise Post-vaccination 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Malaise Post-vaccination 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Myalgia Post-any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}, {'title': 'Myalgia Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Myalgia Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Myalgia Post-vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Myalgia Post-vaccination 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Myalgia Post-vaccination 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5)', 'description': 'A solicited reaction was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, headache, malaise and myalgia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis performed on SafAS. Here, 'number analyzed' = participants with available data for each specified category.1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis. At Vaccination 2, 1 participant of Group 1 received Group 2 vaccine and thus counted in Group 2 for post-vaccination 2 safety analysis."}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 28 Days After any vaccination', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on SafAS. 1 participant of Group 4 received Imovax Rabies vaccine, and thus counted in Group 5 for safety analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'OG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on SafAS. 1 participant of Group 4 received Imovax Rabies vaccine, and thus counted in Group 5 for safety analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), intramuscular (IM) injection on Days 0, 3, 7, 14 and 28. Concomitant administration of human rabies immunoglobulins (HRIG) on Day 0.'}, {'id': 'FG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'FG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'FG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'FG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}], 'periods': [{'title': 'Active Vaccination Phase (Day 0-Day 56)', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '40'}]}, {'type': 'Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'comment': '1 participant of this arm received Imovax Rabies, and counted in Group 5 for safety analysis.', 'groupId': 'FG003', 'numSubjects': '39'}, {'comment': '1 participant of Group 4 received Imovax Rabies, and counted in Group 5 for safety analysis.', 'groupId': 'FG004', 'numSubjects': '41'}]}, {'type': 'Vaccination 2', 'achievements': [{'comment': '1 participant received Group 2 vaccine: counted in Group 2 for post-vaccination 2 safety analysis.', 'groupId': 'FG000', 'numSubjects': '77'}, {'comment': '1 participant of Group 1 received Group 2 vaccine: counted in Group 2 for post-vaccination 2 safety.', 'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '39'}]}, {'type': 'Vaccination 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '38'}]}, {'type': 'Vaccination 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '38'}]}, {'type': 'Vaccination 5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Other Adverse Event (AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Non-compliance with the Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Voluntary Withdrawal Not Due AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Phase (Day 56 Till Month 7)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '73'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Non-compliance with the Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Voluntary Withdrawal not due to AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 5 centers in the United States from 17 April 2017 to 08 January 2018.', 'preAssignmentDetails': 'A total of 320 participants were enrolled and vaccinated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '320', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'BG001', 'title': 'Group 2:VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'BG002', 'title': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'BG003', 'title': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'BG004', 'title': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '42.6', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '14.4', 'groupId': 'BG002'}, {'value': '41.1', 'spread': '13.5', 'groupId': 'BG003'}, {'value': '38.9', 'spread': '13.1', 'groupId': 'BG004'}, {'value': '41.4', 'spread': '13.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '158', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '162', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '217', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-20', 'size': 731234, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-05T09:22', 'hasProtocol': True}, {'date': '2017-07-17', 'size': 2099037, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-05T09:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2019-01-24', 'completionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2017-05-03', 'dispFirstSubmitQcDate': '2019-01-24', 'resultsFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2017-05-05', 'dispFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-07', 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0', 'timeFrame': 'Day 0', 'description': 'RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method.'}, {'measure': 'Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14', 'timeFrame': 'Day 14', 'description': 'RVNA GMT against rabies virus was assessed using the RFFIT assay method.'}, {'measure': 'Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28', 'timeFrame': 'Day 28', 'description': 'RVNA GMT against rabies virus was assessed using the RFFIT assay method.'}, {'measure': 'Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42', 'timeFrame': 'Day 42', 'description': 'RVNA GMT against rabies virus was assessed using the RFFIT assay method.'}, {'measure': 'Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7', 'timeFrame': 'Month 7', 'description': 'RVNA GMT against rabies virus was assessed using the RFFIT assay method.'}, {'measure': 'Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0', 'timeFrame': 'Day 0', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>=0.2 IU/mL were considered as seropositive.'}, {'measure': 'Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14', 'timeFrame': 'Day 14', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>=0.2 IU/mL were considered as seropositive.'}, {'measure': 'Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28', 'timeFrame': 'Day 28', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>=0.2 IU/mL were considered as seropositive.'}, {'measure': 'Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42', 'timeFrame': 'Day 42', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>=0.2 IU/mL were considered as seropositive.'}, {'measure': 'Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7', 'timeFrame': 'Month 7', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \\>= 0.2 IU/mL were considered as seropositive.'}, {'measure': 'Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0)', 'timeFrame': 'Day 0 (pre-dose) and Day 14 (7 days post-dose 3)', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 7 days post 3rd vaccination (i.e., on Day 14) and pre-vaccination on Day 0.'}, {'measure': 'Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0)', 'timeFrame': 'Day 0 (pre-dose) and Day 28 (14 days post-dose 4)', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 4th vaccination (i.e., on Day 28) and pre-vaccination on Day 0.'}, {'measure': 'Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0)', 'timeFrame': 'Day 0 (Pre-dose) and Day 42 (14 days Post-dose 5)', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 5th vaccination (i.e., on Day 42) and pre-vaccination on Day 0.'}, {'measure': 'Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0)', 'timeFrame': 'Day 0 (Pre-dose) and Month 7 (6 Months Post Last Vaccination)', 'description': 'RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 6 month post last vaccination on Month 7 and pre-vaccination on Day 0.'}, {'measure': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0', 'timeFrame': 'Day 0', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.'}, {'measure': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14', 'timeFrame': 'Day 14', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.'}, {'measure': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28', 'timeFrame': 'Day 28', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.'}, {'measure': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42', 'timeFrame': 'Day 42', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.'}, {'measure': 'Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7', 'timeFrame': 'Month 7', 'description': 'Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.'}, {'measure': 'Number of Participants With Immediate Unsolicited Adverse Events', 'timeFrame': 'Within 30 Minutes After any Vaccination', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs).'}, {'measure': 'Number of Participants With at Least One Solicited Injection Site Reactions', 'timeFrame': 'Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5)', 'description': 'A solicited reaction (SR) was an AR observed and reported under conditions (symptoms and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included pain, erythema and swelling at and around the injection site.'}, {'measure': 'Number of Participants With at Least One Solicited Systemic Reactions', 'timeFrame': 'Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5)', 'description': 'A solicited reaction was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, headache, malaise and myalgia.'}, {'measure': 'Number of Participants With at Least One Unsolicited Adverse Events', 'timeFrame': 'Within 28 Days After any vaccination', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 up to Month 7', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rabies virus'], 'conditions': ['Rabies Virus']}, 'referencesModule': {'references': [{'pmid': '37921410', 'type': 'DERIVED', 'citation': 'Pichon S, Guinet-Morlot F, Saleh J, Essink B, Pineda-Pena AC, Moureau A, Petit C, Minutello AM. Safety and immunogenicity of three dose levels of an investigational, highly purified Vero cell rabies vaccine: A randomized, controlled, observer-blinded, Phase II study with a simulated post-exposure regimen in healthy adults. Hum Vaccin Immunother. 2023 Dec 15;19(3):2275453. doi: 10.1080/21645515.2023.2275453. Epub 2023 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.', 'detailedDescription': 'This study assessed different formulations of the modified formulation of VRVg (VRVg 2- formulations 1 \\[low\\], 2 \\[medium\\] and 3 \\[high\\]) tested in parallel to the initial VRVg formulation (VRVg-1) and Imovax Rabies. Immune responses were assessed at Day 14, Day 28, Day 42, and at Month 7. Safety events were also reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAn individual must fulfill all of the following criteria in order to be eligible for trial enrollment:\n\n1. Aged 18 to less than 65 years on the day of inclusion.\n2. Informed consent form had been signed and dated.\n3. Able to attend all scheduled visits and to complied with all trial procedures.\n4. Body Mass Index (BMI): 18.5 kilograms per meter square (Kg/m\\^2) less than or equal to (\\<=) BMI \\<= 30 Kg/m\\^2.\n\nExclusion Criteria:\n\nAn individual fulfilling any of the following criteria was to be excluded from trial enrollment:\n\n1. Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.\n2. Participation at the time of study enrollment or, planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.\n3. Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 6.\n4. Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine.\n5. Receipt of immune globulins, blood or blood-derived products in the past 3 months.\n6. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n7. At high risk for rabies infection during the trial (e.g., veterinarians and staff, animal handlers, rabies researchers, or any others whose activities may bring them into frequent contact with rabies virus or animals who had the rabies virus).\n8. Known systemic hypersensitivity to any of the vaccine or human rabies immunoglobulins (HRIG) components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.\n9. Self-reported thrombocytopenia, contraindicating IM vaccination.\n10. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.\n11. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.\n12. Current alcohol abuse or drug addiction.\n13. Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion (e.g., cardiac disorders, renal disorders, auto immune disorders, diabetes, psychiatric disorders or chronic infection).\n14. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to \\[\\>=\\] 100.4 Fahrenheit \\>=38.0 Celsius). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.\n15. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.\n16. History of Guillain-Barré syndrome.'}, 'identificationModule': {'nctId': 'NCT03145766', 'briefTitle': 'Immunogenicity and Safety of a Purified Vero Rabies Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free When Administered According to a Simulated Rabies Post-exposure Regimen in Healthy Adults', 'orgStudyIdInfo': {'id': 'VRV11'}, 'secondaryIdInfos': [{'id': 'U1111-1174-4976', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: VRVg-2 Formulation 1', 'description': 'VRVg-2 formulation 1, intramuscular (IM) injection on Days 0, 3, 7, 14 and 28. Concomitant administration of human rabies immunoglobulins (HRIG) on Day 0.', 'interventionNames': ['Biological: VRVg 2', 'Biological: Human Rabies Immunoglobulins (HRIG)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: VRVg-2 Formulation 2', 'description': 'VRVg-2 formulation 2, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.', 'interventionNames': ['Biological: VRVg 2', 'Biological: Human Rabies Immunoglobulins (HRIG)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: VRVg-2 Formulation 3', 'description': 'VRVg-2 formulation 3, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.', 'interventionNames': ['Biological: VRVg 2', 'Biological: Human Rabies Immunoglobulins (HRIG)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: VRVg-1', 'description': 'VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.', 'interventionNames': ['Biological: VRVg 1', 'Biological: Human Rabies Immunoglobulins (HRIG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 5: Imovax Rabies', 'description': 'Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.', 'interventionNames': ['Biological: Imovax Rabies', 'Biological: Human Rabies Immunoglobulins (HRIG)']}], 'interventions': [{'name': 'VRVg 2', 'type': 'BIOLOGICAL', 'description': 'Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free', 'armGroupLabels': ['Group 1: VRVg-2 Formulation 1']}, {'name': 'VRVg 1', 'type': 'BIOLOGICAL', 'description': 'Initial formulation of Purified Vero Rabies Vaccine Serum Free', 'armGroupLabels': ['Group 4: VRVg-1']}, {'name': 'Imovax Rabies', 'type': 'BIOLOGICAL', 'description': 'Purified inactivated rabies vaccine prepared on human diploid cell cultures', 'armGroupLabels': ['Group 5: Imovax Rabies']}, {'name': 'VRVg 2', 'type': 'BIOLOGICAL', 'description': 'Modified formulation 2 (Medium) of Purified Vero Rabies Vaccine Serum Free', 'armGroupLabels': ['Group 2: VRVg-2 Formulation 2']}, {'name': 'VRVg 2', 'type': 'BIOLOGICAL', 'description': 'Modified formulation 3 (High) of Purified Vero Rabies Vaccine Serum Free', 'armGroupLabels': ['Group 3: VRVg-2 Formulation 3']}, {'name': 'Human Rabies Immunoglobulins (HRIG)', 'type': 'BIOLOGICAL', 'description': 'Commercialized formulation of HRIG', 'armGroupLabels': ['Group 1: VRVg-2 Formulation 1', 'Group 2: VRVg-2 Formulation 2', 'Group 3: VRVg-2 Formulation 3', 'Group 4: VRVg-1', 'Group 5: Imovax Rabies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96001', 'city': 'Redding', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 40.58654, 'lon': -122.39168}}, {'zip': '92117', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89104', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}