Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 10:17 PM
Study NCT ID:
NCT00347958
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2006-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D014917', 'term': 'Whooping Cough'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}, {'id': 'C509326', 'term': 'adacel'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject 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': 'Adverse events data were collected from the day of vaccination to 6 months post-vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Adacel® Vaccine Group', 'description': 'Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.', 'otherNumAtRisk': 544, 'otherNumAffected': 479, 'seriousNumAtRisk': 544, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 45, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 40, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 472, 'numAffected': 472}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Injection site erythema/redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 154, 'numAffected': 154}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 138, 'numAffected': 138}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pyrexia (Fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 287, 'numAffected': 287}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 206, 'numAffected': 206}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 329, 'numAffected': 329}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Carcinoid tumour of the appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 544, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '544', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adacel® Vaccine Group', 'description': 'Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Any Injection Site Pain', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Injection Site Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Any Injection Site Erythema/Redness', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Injection Site Erythema/Redness (≥ 5 cm)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any Injection Site Swelling', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Injection Site Swelling (≥ 5 cm)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Fever (> 39.0 ºC or > 102.2 ºF)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Headache (Prevents daily activities)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Myalgia (Prevents daily activities)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Malaise (Prevents daily activities)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-14 days post-vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.\n\nThe solicited systemic reaction, malaise was not collected in the previous studies.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adacel® Vaccine Group', 'description': 'Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.'}], 'classes': [{'title': 'Tetanus (IU/mL) Pre-Dose, n = 445', 'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '1.27', 'upperLimit': '1.56'}]}]}, {'title': 'Tetanus (IU/mL) Post-Dose, n = 445', 'categories': [{'measurements': [{'value': '9.62', 'groupId': 'OG000', 'lowerLimit': '9.06', 'upperLimit': '10.2'}]}]}, {'title': 'Diphtheria (IU/mL) no Menactra Pre-Dose, n = 379', 'categories': [{'measurements': [{'value': '0.133', 'groupId': 'OG000', 'lowerLimit': '0.110', 'upperLimit': '0.162'}]}]}, {'title': 'Diphtheria (IU/mL) no Menactra Post-Dose n = 379', 'categories': [{'measurements': [{'value': '2.17', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': '2.56'}]}]}, {'title': 'Diphtheria (IU/mL) with Menactra Pre-Dose n = 64', 'categories': [{'measurements': [{'value': '4.45', 'groupId': 'OG000', 'lowerLimit': '2.77', 'upperLimit': '7.15'}]}]}, {'title': 'Diphtheria (IU/mL) with Menactra Post-Dose n = 64', 'categories': [{'measurements': [{'value': '8.70', 'groupId': 'OG000', 'lowerLimit': '6.59', 'upperLimit': '11.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were assessed in the per-protocol population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adacel® Vaccine Group', 'description': 'Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.'}], 'classes': [{'title': 'Pertussis PT (EU/mL) Pre-Dose, n = 381', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '23.5'}]}]}, {'title': 'Pertussis PT (EU/mL) Post-Dose, n = 425', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '112'}]}]}, {'title': 'Pertussis FHA (EU/mL) Pre-Dose, n = 450', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000', 'lowerLimit': '31.9', 'upperLimit': '37.5'}]}]}, {'title': 'Pertussis FHA (EU/mL) Post-Dose, n = 450', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000', 'lowerLimit': '189', 'upperLimit': '215'}]}]}, {'title': 'Pertussis PRN (EU/mL) Pre-Dose, n = 451', 'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000', 'lowerLimit': '32.7', 'upperLimit': '42.6'}]}]}, {'title': 'Pertussis PRN (EU/mL) Post-Dose, n = 451', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000', 'lowerLimit': '201', 'upperLimit': '236'}]}]}, {'title': 'Pertussis FIM (EU/mL) Pre-Dose, n = 445', 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000', 'lowerLimit': '145', 'upperLimit': '187'}]}]}, {'title': 'Pertussis FIM (EU/mL) Post-Dose, n = 450', 'categories': [{'measurements': [{'value': '749', 'groupId': 'OG000', 'lowerLimit': '697', 'upperLimit': '806'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were assessed in the per-protocol population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adacel® Vaccine Group', 'description': 'Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.'}], 'classes': [{'title': 'Tetanus (IU/mL) Pre-Dose', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': 'Tetanus (IU/mL) Post-Dose', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Diphtheria (IU/mL) without Menactra, Pre-Dose', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Diphtheria (IU/mL) without Menactra, Post-Dose', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'Diphtheria (IU/mL) Menactra, Pre-Dose', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'Diphtheria (IU/mL) Menactra, Post-Dose', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Tetanus and diphtheria antibody analyses were in all enrolled and vaccinated participants in the per-protocol population. Diphtheria antibody titers were analyzed separately for participants without and with an intervening Menactra vaccination between the previous study and Study Td518.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adacel® Vaccine Group', 'description': 'Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '544'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '540'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 21 August 2006, to 12 April 2007, in 6 clinical centers in the US and 6 clinical centers in Canada.', 'preAssignmentDetails': 'A total of 545 participants were enrolled and vaccinated in the study. Data on 544 participants that met the inclusion and exclusion criteria were analyzed and reported. One participant who did not receive Adacel® vaccine in one of the previous studies was excluded from the Safety Analysis Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '544', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adacel® Vaccine Group', 'description': 'Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '169', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '368', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '15.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '284', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '260', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '350', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 545}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-11', 'studyFirstSubmitDate': '2006-07-03', 'resultsFirstSubmitDate': '2010-05-14', 'studyFirstSubmitQcDate': '2006-07-03', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-22', 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.'}, {'measure': 'Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.'}, {'measure': 'Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination', 'timeFrame': '0-14 days post-vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tetanus,', 'Diphtheria,', 'Pertussis'], 'conditions': ['Tetanus', 'Diphtheria', 'Pertussis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nTo provide safety data on revaccination with ADACEL® vaccine.\n\nTo describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505.\n* At least 15 but no greater than 69 years of age at the time of vaccination in this trial.\n* Signed Institutional Review Board (IRB)-approved informed assent / consent form.\n* Able to attend all scheduled visits and to comply with all trial procedures.\n* For a woman, inability to become pregnant or negative serum/urine pregnancy test.\n\nExclusion Criteria:\n\n* Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.\n* Serious chronic disease (ie, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that might:\n\n * interfere with the ability to participate fully in the study; or\n * interfere with evaluation of the vaccine.\n* Known or suspected impairment of immunologic function.\n* Febrile illness within the last 72 hours or an oral temperature ≥100.4°F (≥38°C) at the time of inclusion.\n* History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.\n* Known or suspected receipt of a tetanus-, diphtheria- or pertussis-containing vaccine since participation in Study Td501, Td502, or Td505. (Receipt of Menactra vaccine at any time prior to the present study is permitted, subject to the next exclusion criterion).\n* Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 28-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment\n* Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.\n* Suspected or known hypersensitivity to any of the vaccine components or to latex.\n* Unable to attend the scheduled visits or to comply with the study procedures.\n* In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment.\n* Nursing mother.\n* Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.\n* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial visits or procedures.\n* Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.\n* Subject deprived of freedom by an administrative or court order, or under the stress of an emergency setting, or hospitalized without his/her consent."}, 'identificationModule': {'nctId': 'NCT00347958', 'briefTitle': 'Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety Among Adolescents and Adults of Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) 4 to 5 Years After a Previous Dose', 'orgStudyIdInfo': {'id': 'TD518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adacel vaccine group', 'description': 'Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.', 'interventionNames': ['Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine']}], 'interventions': [{'name': 'Tetanus-diphtheria-acellular pertussis (Tdap) vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Adacel®'], 'description': '0.5mL, Intramuscular (IM)', 'armGroupLabels': ['Adacel vaccine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '71111', 'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'zip': '44118', 'city': 'University Heights', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.49783, 'lon': -81.53735}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': 'V3C 4J2', 'city': 'Coquitlam', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.2846, 'lon': -122.78217}}, {'zip': 'V3R-8P8', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'R3E 3P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3K-6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'G1E 7G9', 'city': 'Beauport', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.85884, 'lon': -71.19201}}, {'zip': 'H3H LP3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}