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Trial record 1 of 1 for:    TD515
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A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older

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ClinicalTrials.gov Identifier: NCT00457249
Recruitment Status : Completed
First Posted : April 6, 2007
Results First Posted : October 19, 2012
Last Update Posted : October 19, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Pertussis
Tetanus
Diphtheria
Interventions Biological: ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Biological: DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
Enrollment 1564
Recruitment Details Participants were enrolled from 28 March to 30 October 2007, at 19 clinic centers in United States.
Pre-assignment Details A total of 1563 participants were enrolled; 1561 were vaccinated with data analyzed and presented in this report.
Arm/Group Title ADACEL® Vaccine Group DECAVAC® Vaccine Group
Hide Arm/Group Description Participants received a single dose of ADACEL® vaccine. Participants received a single dose of DECAVAC® vaccine.
Period Title: Overall Study
Started 1170 391
Completed 1158 389
Not Completed 12 2
Reason Not Completed
Lost to Follow-up             3             0
Protocol Violation             4             1
Withdrawal by Subject             3             1
Serious Adverse Events             2             0
Arm/Group Title ADACEL® Vaccine Group DECAVAC® Vaccine Group Total
Hide Arm/Group Description Participants received a single dose of ADACEL® vaccine. Participants received a single dose of ADACEL® vaccine. Total of all reporting groups
Overall Number of Baseline Participants 1170 391 1561
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1170 participants 391 participants 1561 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
1170
 100.0%
391
 100.0%
1561
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1170 participants 391 participants 1561 participants
72.2  (5.74) 72.3  (5.63) 72.2  (5.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1170 participants 391 participants 1561 participants
Female
579
  49.5%
198
  50.6%
777
  49.8%
Male
591
  50.5%
193
  49.4%
784
  50.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1170 participants 391 participants 1561 participants
1170 391 1561
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Hide Description [Not Specified]
Time Frame Day 35 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs and their 95% Confidence Intervals were assessed in the per-protocol population.
Arm/Group Title ADACEL® Vaccine Group DECAVAC® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of ADACEL® vaccine.
Participants received a single dose of ADACEL® vaccine.
Overall Number of Participants Analyzed 1094 371
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Tetanus (Pre-vaccination: N = 1089; 368)
0.501
(0.445 to 0.564)
0.451
(0.365 to 0.558)
Tetanus (Post-vaccination: N = 1075; 368)
8.43
(7.78 to 9.14)
7.23
(6.23 to 8.38)
Diphtheria (Pre-vaccination: N = 1092; 370)
0.049
(0.043 to 0.056)
0.056
(0.045 to 0.071)
Diphtheria (Post-vaccination: N = 1093; 371)
0.570
(0.489 to 0.665)
0.505
(0.401 to 0.636)
Pertussis Toxoid (Pre-vaccination: N = 1013; 345)
10.6
(9.81 to 11.5)
12.7
(11.1 to 14.5)
Pertussis Toxoid (Post-vaccination: N = 1022; 341)
59.4
(55.2 to 63.8)
15
(13.1 to 17.2)
Filamentous Hemagglutinin (Pre-vacc: N=1091; 370)
25.5
(23.9 to 27.1)
25.6
(22.8 to 28.8)
Filamentous Hemagglutinin (Post-Vacc: N=1094; 371)
197
(186 to 209)
26.6
(23.7 to 30)
Pertactin (Pre-Vaccination: N = 1090; 370)
4.56
(4.26 to 4.88)
4.71
(4.18 to 5.31)
Pertactin (Post-Vaccination: N = 1094; 370)
69.2
(61.6 to 77.9)
5.34
(4.72 to 6.04)
Fimbriae Type 2 & 3 (Pre-Vaccination: N=1053; 370)
8.28
(7.46 to 9.19)
9.59
(7.94 to 11.6)
Fimbriae Type 2 & 3 (Post-Vaccination: N=1060; 352
183
(164 to 205)
10.6
(8.79 to 12.9)
2.Primary Outcome
Title Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.
Hide Description Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.
Time Frame Day 35 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the per-protocol population
Arm/Group Title Adacel® Vaccine Group DECAVAC® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of ADACEL® vaccine.
Participants received a single dose of DECAVAC® vaccine.
Overall Number of Participants Analyzed 1093 371
Measure Type: Number
Unit of Measure: Percentage of Participants
Tetanus (N = 1075; 368) 98 98
Diphtheria (N = 1093; 371) 77 79
3.Primary Outcome
Title Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.
Hide Description Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value.
Time Frame Day 35 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster response was assessed in the per-protocol population.
Arm/Group Title ADACEL® Vaccine Group DECAVAC® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of ADACEL® vaccine.
Participants received a single dose of ADACEL® vaccine.
Overall Number of Participants Analyzed 1091 370
Measure Type: Number
Unit of Measure: Percentage of Participants
Tetanus (N = 1071; 365) 77 77
Diphtheria (N = 1091; 370) 71 66
4.Other Pre-specified Outcome
Title Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise.
Time Frame Day 0 up to 14 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.
Arm/Group Title ADACEL® Vaccine Group DECAVAC® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of ADACEL® vaccine.
Participants received a single dose of ADACEL® vaccine.
Overall Number of Participants Analyzed 1170 391
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 615 200
Any injection site Pain 496 163
Grade 3 injection site Pain (Incapacitating) 6 1
Any injection site Erythema 280 86
Grade 3 injection site Erythema (≥ 3.5 cm) 52 19
Any injection site Swelling 209 59
Grade 3 injection site Swelling (≥ 3.5 cm) 40 17
Any Solicited Systemic Reaction 420 155
Any Fever 6 2
Grade 3 Fever (≥ 39.5ºC or ≥ 103.1ºF) 1 0
Any Headache 209 76
Grade 3 Headache (Incapacitating) 7 4
Any Myalgia 327 108
Grade 3 Myalgia (Incapacitating) 17 6
Any Malaise 198 63
Grade 3 Malaise (Incapacitating) 13 6
Time Frame Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADACEL® Vaccine Group DECAVAC® Vaccine Group
Hide Arm/Group Description Participants received a single dose of ADACEL® vaccine. Participants received a single dose of ADACEL® vaccine.
All-Cause Mortality
ADACEL® Vaccine Group DECAVAC® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ADACEL® Vaccine Group DECAVAC® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/1170 (4.19%)      20/391 (5.12%)    
Cardiac disorders     
Acute coronary syndrome * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Acute myocardial infarction * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Arrhythmia * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Atrial fibrillation * 1  4/1170 (0.34%)  4 0/391 (0.00%)  0
Cardiac arrest * 1  1/1170 (0.09%)  1 1/391 (0.26%)  1
Cardiac failure congestive * 1  4/1170 (0.34%)  4 1/391 (0.26%)  1
Coronary artery disease * 1  3/1170 (0.26%)  3 1/391 (0.26%)  1
Intracardiac thrombus * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Myocardial infarction * 1  2/1170 (0.17%)  2 0/391 (0.00%)  0
Endocrine disorders     
Adrenocortical insufficiency chronic * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Gastrointestinal disorders     
Barrett's oesophagus * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Duodenal ulcer * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Gastritis * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Gastrointestinal haemorrhage * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Gastrooesophageal reflux disease * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Intestinal obstruction * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Melaena * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Pancreatitis * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Small intestinal obstruction * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Volvulus * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
General disorders     
Adverse drug reaction * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Hernia obstructive * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Multi-organ failure * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Non-cardiac chest pain * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Cholelithiasis * 1  2/1170 (0.17%)  2 2/391 (0.51%)  2
Infections and infestations     
Appendicitis * 1  1/1170 (0.09%)  1 2/391 (0.51%)  2
Bronchitis * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Bursitis infective * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Cellulitis * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Diverticulitis * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Escherichia infection * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Gastroenteritis * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Pneumonia * 1  3/1170 (0.26%)  3 1/391 (0.26%)  1
Sepsis * 1  2/1170 (0.17%)  2 0/391 (0.00%)  0
Staphylococcal bacteraemia * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Urinary tract infection * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Viral infection * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Injury, poisoning and procedural complications     
Hip fracture * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Joint injury * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Meniscus lesion * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Spinal fracture * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Stent occlusion * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Diabetes mellitus * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Diabetes mellitus inadequate control * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Diabetes mellitus non-insulin-dependent * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Diabetic ketoacidosis * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/1170 (0.09%)  1 1/391 (0.26%)  1
Muscle haemorrhage * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Myositis * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Spinal column stenosis * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  1/1170 (0.09%)  1 1/391 (0.26%)  1
Bladder cancer * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Hepatic neoplasm malignant * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Prostate cancer * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Renal cell carcinoma stage unspecified * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Small cell lung cancer stage unspecified * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Squamous cell carcinoma * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Uterine cancer * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident * 1  4/1170 (0.34%)  4 1/391 (0.26%)  1
Intracranial venous sinus thrombosis * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Subarachnoid haemorrhage * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Syncope * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Transient ischaemic attack * 1  1/1170 (0.09%)  1 1/391 (0.26%)  1
Renal and urinary disorders     
Hydronephrosis * 1  2/1170 (0.17%)  2 0/391 (0.00%)  0
Renal artery stenosis * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/1170 (0.00%)  0 1/391 (0.26%)  1
Vascular disorders     
Hypertension * 1  0/1170 (0.00%)  0 1/391 (0.26%)  2
Hypertensive crisis * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
Peripheral embolism * 1  1/1170 (0.09%)  1 0/391 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ADACEL® Vaccine Group DECAVAC® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   615/1170 (52.56%)      200/391 (51.15%)    
General disorders     
Injection site pain  1  496/1170 (42.39%)  163/391 (41.69%) 
Injection site erythema  1  280/1170 (23.93%)  86/391 (21.99%) 
Injection site swelling * 1  209/1170 (17.86%)  59/391 (15.09%) 
Malaise * 1  198/1170 (16.92%)  63/391 (16.11%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  327/1170 (27.95%)  108/391 (27.62%) 
Nervous system disorders     
Headache * 1  209/1170 (17.86%)  76/391 (19.44%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00457249     History of Changes
Other Study ID Numbers: TD515
First Submitted: April 5, 2007
First Posted: April 6, 2007
Results First Submitted: September 17, 2012
Results First Posted: October 19, 2012
Last Update Posted: October 19, 2012