Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td
Study Details
Study Description
Brief Summary
To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age.
To compare the post-vaccination geometric mean titers of antibody (GMTs) to Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the post-vaccination GMTs to the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This is a multi-center, partially open-label, partially randomized double blind trial for immunogenicity and safety in the United States. Participants will be enrolled to one of three treatment groups:
-
Subjects ages 11-59 years will receive Canadian manufactured Td vaccine on Day 0
-
Subjects 60 years or older will be randomized to receive either US manufactured Td on Day 0, or,
-
Subjects 60 years or older randomized to receive Canadian manufactured Td on Day 0
The trial is designed to assess the safety of Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine in all trial participants 11 to 59 years of age and to describe the immune responses in subsets of adolescents (11-14, and 15-18 years of age) and in a subset of adults 19-59 years of age. The trial will also compare the immune responses and safety in subjects ≥ 60 years of age receiving Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to an equal number of subjects ≥ 60 years of age receiving US Manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Canadian Td Vaccine Group Participants received Canadian manufactured Td vaccine |
Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
0.5 mL, Intramuscular, single dose
Other Names:
|
| Active Comparator: United States Td Vaccine Group Participants received US manufactured Td vaccine |
Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
0.5 mL, Intramuscular, Single dose
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria. [28 Days post-vaccination]
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.
Secondary Outcome Measures
- 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. [28 Days post-vaccination]
Other Outcome Measures
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. [0-14 days post-vaccination]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant is healthy as per medical history reported by subject.
-
Participant is at least 11 years of age at the time of vaccination.
-
Participant has a signed Institutional Review Board (IRB)-approved informed assent/consent form. For subjects 11 to 17 years of age, a written informed consent must be obtained from parent(s) or legal guardian(s) and a written informed assent must be obtained from the subject
-
Participant provides history or documentation of primary or booster immunization with Diphtheria and Tetanus.
-
Female participants of childbearing potential must have a negative urine pregnancy test at the time of enrollment.
Exclusion Criteria:
-
Serious and uncontrolled chronic disease (i.e., cardiac, pulmonary, renal, neurologic, metabolic, rheumatologic, etc.).
-
Known or suspected impairment of immunologic function.
-
Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment.
-
Administration of immune globulin or other blood products within the last three months; administration of corticosteroids (injected or oral) or other immunomodulatory therapy within six weeks of the study vaccine. However, individuals on a tapering dose schedule of oral steroids may be included in the trial, as long as steroids were discontinued more than two weeks prior to enrollment.
-
Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccination, other than influenza prior to Visit 2 blood draw. For influenza vaccine only, exclude if received in the 14 day period prior to enrollment or scheduled to receive in the 14 day period after Visit 1.
-
Suspected or known hypersensitivity to Td components, thimerosal (for subjects > 60 years of age) or latex rubber.
-
Unable to attend scheduled visits or unable to comply with the study procedures.
-
Enrolled in another clinical trial.
-
Any condition that would pose a health risk to the participant or interfere with the evaluation of the vaccine in the opinion of the investigator.
-
A positive urine pregnancy test at the time of enrollment for all females of childbearing potential.
-
Female of childbearing potential who does not agree either to remain abstinent or to use effective birth control during the period of the trial.
-
Breast feeding during the period of the trial.
-
A history of Guillain- Barré syndrome within 6 weeks after a previous dose of a tetanus toxoid-containing vaccine.
-
Receipt of a tetanus or diphtheria vaccination within the 5 years prior to enrollment.
-
A previous history of diphtheria disease within the last 25 years or tetanus disease
-
History of Arthus-type hypersensitivity reaction or a temperature >103° F following a prior dose of tetanus toxoid, unless 10 years have elapsed since the previous dose.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oakland | California | United States | 94611 | |
| 2 | Pittsburgh | Pennsylvania | United States | 15241 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- TDC01
Study Results
Participant Flow
| 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 Detail | 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 |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Canadian Td Vaccine Group | United States Td Vaccine Group | Total |
|---|---|---|---|
| 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 Participants | 2950 | 700 | 3650 |
| Age (Count of Participants) | |||
| <=18 years |
1501
50.9%
|
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 (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
33.6
(23.49)
|
69.3
(7.89)
|
40.5
(25.60)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1629
55.2%
|
403
57.6%
|
2032
55.7%
|
| Male |
1321
44.8%
|
297
42.4%
|
1618
44.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
2950
100%
|
700
100%
|
3650
100%
|
Outcome Measures
| Title | Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria. |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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®) |
| Measure Participants | 661 | 658 |
| Tetanus Post-vaccination Seroprotection |
96
3.3%
|
97
13.9%
|
| Diphtheria Post-vaccination Seroprotection |
71
2.4%
|
71
10.1%
|
| Tetanus Booster Response |
82
2.8%
|
84
12%
|
| Diphtheria Booster Response |
66
2.2%
|
63
9%
|
| 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. |
|---|---|
| Description | |
| Time Frame | 28 Days post-vaccination |
Outcome Measure Data
| 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 |
|---|---|---|
| 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®) |
| Measure Participants | 661 | 658 |
| Tetanus post-vaccination |
6.83
|
7.35
|
| Diphtheria post-vaccination |
0.459
|
0.409
|
| 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. |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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®) |
| Measure Participants | 1450 | 700 |
| Any Injection site pain |
832
28.2%
|
209
29.9%
|
| Grade 3 Injection site pain (require medical care) |
7
0.2%
|
5
0.7%
|
| Any Injection site redness |
299
10.1%
|
132
18.9%
|
| Grade 3 Injection site redness (≥ 50 mm) |
28
0.9%
|
20
2.9%
|
| Any Injection site swelling |
205
6.9%
|
93
13.3%
|
| Grade 3 Injection site swelling (≥ 50 mm) |
32
1.1%
|
11
1.6%
|
| Any Chills |
80
2.7%
|
32
4.6%
|
| Grade 3 Chills (Incapacitating) |
5
0.2%
|
2
0.3%
|
| Any Diarrhea |
152
5.2%
|
53
7.6%
|
| Grade 3 Diarrhea (≥ 5 episodes) |
6
0.2%
|
1
0.1%
|
| Any Fever |
95
3.2%
|
40
5.7%
|
| Grade 3 Fever (≥ 39.0 °C) |
2
0.1%
|
1
0.1%
|
| Any Headache |
380
12.9%
|
122
17.4%
|
| Grade 3 Headache (Incapacitating) |
16
0.5%
|
4
0.6%
|
| Any Malaise |
226
7.7%
|
90
12.9%
|
| Grade 3 Malaise (Incapacitating) |
13
0.4%
|
6
0.9%
|
| Any Muscle weakness |
267
9.1%
|
61
8.7%
|
| Grade 3 Muscle weakness (Incapacitating) |
6
0.2%
|
2
0.3%
|
| Any Nausea |
106
3.6%
|
34
4.9%
|
| Grade 3 Nausea (Incapacitating) |
6
0.2%
|
1
0.1%
|
| Any Pain in joints |
201
6.8%
|
74
10.6%
|
| Grade 3 Pain in joints (Incapacitating) |
7
0.2%
|
1
0.1%
|
| Any Vomiting |
33
1.1%
|
6
0.9%
|
| Grade 3 Vomiting (≥ 3 episodes) |
6
0.2%
|
1
0.1%
|
Adverse Events
| Time Frame | Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Canadian Td Vaccine Group | United States Td Vaccine Group | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Canadian Td Vaccine Group | United States Td Vaccine Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 58/2950 (2%) | 44/700 (6.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/2950 (0.1%) | 2 | 1/700 (0.1%) | 1 |
| Thrombocytopenia | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Cardiac disorders | ||||
| Acute myocardial infarction | 0/2950 (0%) | 0 | 2/700 (0.3%) | 2 |
| Angina pectoris | 1/2950 (0%) | 1 | 2/700 (0.3%) | 2 |
| Atrial fibrillation | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Cardiac failure congestive | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Cardio-respiratory arrest | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Cardiomyopathy | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Myocardial infarction | 1/2950 (0%) | 1 | 2/700 (0.3%) | 2 |
| Congenital, familial and genetic disorders | ||||
| Moebius II syndrome | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Endocrine disorders | ||||
| Thyroid mass | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Eye disorders | ||||
| Retinal artery occlusion | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Colonic polyp | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Dysphagia | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Gastric ulcer perforation | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Ileus | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Inguinal hernia | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Oesophageal achalasia | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Peritonitis | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Rectocele | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| General disorders | ||||
| Chest discomfort | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Chest pain | 2/2950 (0.1%) | 2 | 4/700 (0.6%) | 4 |
| Death | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Non-cardiac chest pain | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Hepatobiliary disorders | ||||
| Cholecystitis | 2/2950 (0.1%) | 2 | 0/700 (0%) | 0 |
| Cholecystitis chronic | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Cholelithiasis | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Infections and infestations | ||||
| Bronchitis | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Bronchitis acute | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Cellulitis | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Cystitis | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Diverticulitis | 2/2950 (0.1%) | 2 | 0/700 (0%) | 0 |
| Gangrene | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Gastroenteritis | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Infectious mononucleosis | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Influenza | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Localised infection | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Pneumonia | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Septic shock | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Viral infection | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Contusion | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Femoral neck fracture | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Fibula fracture | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Head injury | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Hepatic trauma | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Hip Fracture | 2/2950 (0.1%) | 2 | 0/700 (0%) | 0 |
| Joint dislocation | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Post procedural haematoma | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Rib fracture | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Spinal compression fracture | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Tibia fracture | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Wound | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Wrist fracture | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Hyponatraemia | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthropathy | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Back Pain | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Lumbar spinal stenosis | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Musculoskeletal chest pain | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Osteoarthritis | 1/2950 (0%) | 1 | 3/700 (0.4%) | 3 |
| Rotator cuff syndrome | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Scoliosis | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer | 0/2950 (0%) | 0 | 3/700 (0.4%) | 3 |
| Colon Cacer | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Hepatic neoplasm malignant | 0/2950 (0%) | 0 | 2/700 (0.3%) | 2 |
| Metastatic squamous cell carcinoma | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Pancreatic neoplasm | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Paraganglion neoplasm malignant | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Prostate cancer | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Nervous system disorders | ||||
| Carotid artery stenosis | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Cerebrovascular accident | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Guillain-Barre syndrome | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Post-traumatic headache | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Transient ischaemic attack | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Abortion spontaneous | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Psychiatric disorders | ||||
| Confusional state | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Depression | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Suicide attempt | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Renal and urinary disorders | ||||
| Calculus ureteric | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Cystocele | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Haematuria | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Nephrolithiasis | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Urethral obstruction | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Urinary incontinence | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Urinary retention | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Reproductive system and breast disorders | ||||
| Endometriosis | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Pelvic prolapse | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Benign prostatic hyperplasia | 0/2950 (0%) | 0 | 2/700 (0.3%) | 2 |
| Asthma | 2/2950 (0.1%) | 2 | 0/700 (0%) | 0 |
| Atelectasis | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Chronic obstructive pulmonary disease exacerbated | 0/2950 (0%) | 0 | 1/700 (0.1%) | 1 |
| Chronic obstructive airways disease | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Dyspnoea | 1/2950 (0%) | 1 | 1/700 (0.1%) | 1 |
| Pleural effusion | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Vascular disorders | ||||
| Arterial rupture | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Deep vein thrombosis | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
| Haematoma | 1/2950 (0%) | 1 | 0/700 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Canadian Td Vaccine Group | United States Td Vaccine Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 832/2950 (28.2%) | 209/700 (29.9%) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | 152/1434 (10.6%) | 152 | 53/693 (7.6%) | 53 |
| Nausea | 106/1434 (7.4%) | 106 | 34/692 (4.9%) | 34 |
| General disorders | ||||
| Injection site pain | 832/1434 (58%) | 832 | 209/693 (30.2%) | 209 |
| Injection site redness | 299/1434 (20.9%) | 299 | 132/693 (19%) | 132 |
| Injection site swelling | 205/1434 (14.3%) | 205 | 93/693 (13.4%) | 93 |
| Chills | 80/1434 (5.6%) | 80 | 32/693 (4.6%) | 32 |
| Pyrexia | 95/1427 (6.7%) | 95 | 40/687 (5.8%) | 40 |
| Malaise | 226/1433 (15.8%) | 226 | 90/692 (13%) | 90 |
| Musculoskeletal and connective tissue disorders | ||||
| Muscle weakness | 267/1434 (18.6%) | 267 | 61/692 (8.8%) | 61 |
| Pains in joints | 201/1434 (14%) | 201 | 74/693 (10.7%) | 74 |
| Nervous system disorders | ||||
| Headache | 380/1434 (26.5%) | 380 | 122/693 (17.6%) | 122 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
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