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Trial record 1 of 1 for:    TDC01
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Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00601835
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : February 18, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Intervention Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
Enrollment 3651
Recruitment Details Participants were enrolled in the study from 06 May 2004 through 13 December 2004, in 2 medical sites (4 investigators) in the US.
Pre-assignment Details

A total of 3,651 participants that met the inclusion and exclusion criteria were enrolled in the study. One participant declined vaccination.

The immunogenicity subsets consist of all participants ≥ 60 years of age; the safety subsets consist of all participants ≥ 60 years of age and one third of participants 11 to 59 years of age.

Arm/Group Title Canadian Td Vaccine Group United States Td Vaccine Group
Hide Arm/Group Description Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™) Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Period Title: Overall Study
Started 2950 700
Completed 2890 686
Not Completed 60 14
Reason Not Completed
Withdrawal by Subject             9             6
Physician Decision             1             0
Lost to Follow-up             37             5
Adverse Event             1             1
Relocate             12             2
Arm/Group Title Canadian Td Vaccine Group United States Td Vaccine Group Total
Hide Arm/Group Description Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™) Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®) Total of all reporting groups
Overall Number of Baseline Participants 2950 700 3650
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2950 participants 700 participants 3650 participants
<=18 years
1501
  50.9%
0
   0.0%
1501
  41.1%
Between 18 and 65 years
1000
  33.9%
257
  36.7%
1257
  34.4%
>=65 years
449
  15.2%
443
  63.3%
892
  24.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2950 participants 700 participants 3650 participants
33.6  (23.49) 69.3  (7.89) 40.5  (25.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2950 participants 700 participants 3650 participants
Female
1629
  55.2%
403
  57.6%
2032
  55.7%
Male
1321
  44.8%
297
  42.4%
1618
  44.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2950 participants 700 participants 3650 participants
2950 700 3650
1.Primary Outcome
Title Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.
Hide Description Seroprotection and booster responses for both tetanus and diphtheria were considered to be an antibody level of ≥ 0.10 IU/mL 28 days post-vaccination with either the Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine or the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine in participants ≥ 60 years of age.
Time Frame 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection and Booster Responses to Tetanus and Diphtheria were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population.
Arm/Group Title Canadian Td Vaccine Group United States Td Vaccine Group
Hide Arm/Group Description:
Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Overall Number of Participants Analyzed 661 658
Measure Type: Number
Unit of Measure: Percentage of participants
Tetanus Post-vaccination Seroprotection 96 97
Diphtheria Post-vaccination Seroprotection 71 71
Tetanus Booster Response 82 84
Diphtheria Booster Response 66 63
2.Secondary Outcome
Title Post-vaccination Geometric Mean Titer (GMT) to Tetanus and Diphtheria in Participants ≥ 60 Years Vaccinated With Canadian-manufactured or US-manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.
Hide Description [Not Specified]
Time Frame 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population
Arm/Group Title Canadian Td Vaccine Group United States Td Vaccine Group
Hide Arm/Group Description:
Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Overall Number of Participants Analyzed 661 658
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Tetanus post-vaccination
6.83
(6.01 to 7.77)
7.35
(6.54 to 8.26)
Diphtheria post-vaccination
0.459
(0.371 to 0.567)
0.409
(0.332 to 0.504)
3.Other Pre-specified Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.
Hide Description Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Chills, Diarrhea, Fever (temperature), Headache, Malaise, Muscle weakness, Nausea, Pain in joints, Rash, and Vomiting.
Time Frame 0-14 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited safety parameters were in all enrolled and vaccinated participants ≥ 60 years of age and one third of participants 11 to 59 years of age. A subset of the intend-to-treat population.
Arm/Group Title Canadian Td Vaccine Group United States Td Vaccine Group
Hide Arm/Group Description:
Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Overall Number of Participants Analyzed 1450 700
Measure Type: Number
Unit of Measure: Participants
Any Injection site pain 832 209
Grade 3 Injection site pain (require medical care) 7 5
Any Injection site redness 299 132
Grade 3 Injection site redness (≥ 50 mm) 28 20
Any Injection site swelling 205 93
Grade 3 Injection site swelling (≥ 50 mm) 32 11
Any Chills 80 32
Grade 3 Chills (Incapacitating) 5 2
Any Diarrhea 152 53
Grade 3 Diarrhea (≥ 5 episodes) 6 1
Any Fever 95 40
Grade 3 Fever (≥ 39.0 °C) 2 1
Any Headache 380 122
Grade 3 Headache (Incapacitating) 16 4
Any Malaise 226 90
Grade 3 Malaise (Incapacitating) 13 6
Any Muscle weakness 267 61
Grade 3 Muscle weakness (Incapacitating) 6 2
Any Nausea 106 34
Grade 3 Nausea (Incapacitating) 6 1
Any Pain in joints 201 74
Grade 3 Pain in joints (Incapacitating) 7 1
Any Vomiting 33 6
Grade 3 Vomiting (≥ 3 episodes) 6 1
Time Frame Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Canadian Td Vaccine Group United States Td Vaccine Group
Hide Arm/Group Description Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™) Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
All-Cause Mortality
Canadian Td Vaccine Group United States Td Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Canadian Td Vaccine Group United States Td Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/2950 (1.97%)      44/700 (6.29%)    
Blood and lymphatic system disorders     
Anaemia * 1  2/2950 (0.07%)  2 1/700 (0.14%)  1
Thrombocytopenia * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction * 1  0/2950 (0.00%)  0 2/700 (0.29%)  2
Angina pectoris * 1  1/2950 (0.03%)  1 2/700 (0.29%)  2
Atrial fibrillation * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Cardiac failure congestive * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Cardio-respiratory arrest * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Cardiomyopathy * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Myocardial infarction * 1  1/2950 (0.03%)  1 2/700 (0.29%)  2
Congenital, familial and genetic disorders     
Moebius II syndrome * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Endocrine disorders     
Thyroid mass * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Eye disorders     
Retinal artery occlusion * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Gastrointestinal disorders     
Abdominal pain * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Colonic polyp * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Dysphagia * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Gastric ulcer perforation * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Ileus * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Inguinal hernia * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Oesophageal achalasia * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Peritonitis * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Rectocele * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
General disorders     
Chest discomfort * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Chest pain * 1  2/2950 (0.07%)  2 4/700 (0.57%)  4
Death * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Non-cardiac chest pain * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Hepatobiliary disorders     
Cholecystitis * 1  2/2950 (0.07%)  2 0/700 (0.00%)  0
Cholecystitis chronic * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Cholelithiasis * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Infections and infestations     
Bronchitis * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Bronchitis acute * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Cellulitis * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Cystitis * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Diverticulitis * 1  2/2950 (0.07%)  2 0/700 (0.00%)  0
Gangrene * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Gastroenteritis * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Infectious mononucleosis * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Influenza * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Localised infection * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Pneumonia * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Septic shock * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Viral infection * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Injury, poisoning and procedural complications     
Contusion * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Femoral neck fracture * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Fibula fracture * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Head injury * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Hepatic trauma * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Hip Fracture * 1  2/2950 (0.07%)  2 0/700 (0.00%)  0
Joint dislocation * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Post procedural haematoma * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Rib fracture * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Spinal compression fracture * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Tibia fracture * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Wound * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Wrist fracture * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Hyponatraemia * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthropathy * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Back Pain * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Lumbar spinal stenosis * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Musculoskeletal chest pain * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Osteoarthritis * 1  1/2950 (0.03%)  1 3/700 (0.43%)  3
Rotator cuff syndrome * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Scoliosis * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  0/2950 (0.00%)  0 3/700 (0.43%)  3
Colon Cacer * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Hepatic neoplasm malignant * 1  0/2950 (0.00%)  0 2/700 (0.29%)  2
Metastatic squamous cell carcinoma * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Pancreatic neoplasm * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Paraganglion neoplasm malignant * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Prostate cancer * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Nervous system disorders     
Carotid artery stenosis * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Cerebrovascular accident * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Guillain-Barre syndrome * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Post-traumatic headache * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Transient ischaemic attack * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Psychiatric disorders     
Confusional state * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Depression * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Suicide attempt * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Renal and urinary disorders     
Calculus ureteric * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Cystocele * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Haematuria * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Nephrolithiasis * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Urethral obstruction * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Urinary incontinence * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Urinary retention * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Reproductive system and breast disorders     
Endometriosis * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Pelvic prolapse * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Benign prostatic hyperplasia * 1  0/2950 (0.00%)  0 2/700 (0.29%)  2
Asthma * 1  2/2950 (0.07%)  2 0/700 (0.00%)  0
Atelectasis * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Chronic obstructive pulmonary disease exacerbated * 1  0/2950 (0.00%)  0 1/700 (0.14%)  1
Chronic obstructive airways disease * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Dyspnoea * 1  1/2950 (0.03%)  1 1/700 (0.14%)  1
Pleural effusion * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Vascular disorders     
Arterial rupture * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Deep vein thrombosis * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
Haematoma * 1  1/2950 (0.03%)  1 0/700 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Canadian Td Vaccine Group United States Td Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   832/2950 (28.20%)      209/700 (29.86%)    
Gastrointestinal disorders     
Diarrhea  1  152/1434 (10.60%)  152 53/693 (7.65%)  53
Nausea  1  106/1434 (7.39%)  106 34/692 (4.91%)  34
General disorders     
Injection site pain  1  832/1434 (58.02%)  832 209/693 (30.16%)  209
Injection site redness  1  299/1434 (20.85%)  299 132/693 (19.05%)  132
Injection site swelling  1  205/1434 (14.30%)  205 93/693 (13.42%)  93
Chills  1  80/1434 (5.58%)  80 32/693 (4.62%)  32
Pyrexia  1  95/1427 (6.66%)  95 40/687 (5.82%)  40
Malaise  1  226/1433 (15.77%)  226 90/692 (13.01%)  90
Musculoskeletal and connective tissue disorders     
Muscle weakness  1  267/1434 (18.62%)  267 61/692 (8.82%)  61
Pains in joints  1  201/1434 (14.02%)  201 74/693 (10.68%)  74
Nervous system disorders     
Headache  1  380/1434 (26.50%)  380 122/693 (17.60%)  122
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00601835     History of Changes
Other Study ID Numbers: TDC01
First Submitted: January 15, 2008
First Posted: January 28, 2008
Results First Submitted: November 16, 2009
Results First Posted: February 18, 2011
Last Update Posted: April 14, 2016