Trial Outcomes & Findings for Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td (NCT NCT00601835)

NCT ID: NCT00601835

Last Updated: 2016-04-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 3651 participants
• Primary outcome timeframe: 28 Days post-vaccination
• Results posted on: 2016-04-14

Participant Flow

Participants were enrolled in the study from 06 May 2004 through 13 December 2004, in 2 medical sites (4 investigators) in the US.

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.

Participant milestones

Measure	Canadian Td Vaccine Group Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)	United States Td Vaccine Group Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Overall Study STARTED	2950	700
Overall Study COMPLETED	2890	686
Overall Study NOT COMPLETED	60	14

Reasons for withdrawal

Measure	Canadian Td Vaccine Group Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)	United States Td Vaccine Group Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Overall Study Withdrawal by Subject	9	6
Overall Study Physician Decision	1	0
Overall Study Lost to Follow-up	37	5
Overall Study Adverse Event	1	1
Overall Study Relocate	12	2

Baseline Characteristics

Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td

Baseline characteristics by cohort

Measure	Canadian Td Vaccine Group n=2950 Participants Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)	United States Td Vaccine Group n=700 Participants Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)	Total n=3650 Participants Total of all reporting groups
Age, Categorical <=18 years	1501 Participants n=5 Participants	0 Participants n=7 Participants	1501 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1000 Participants n=5 Participants	257 Participants n=7 Participants	1257 Participants n=5 Participants
Age, Categorical >=65 years	449 Participants n=5 Participants	443 Participants n=7 Participants	892 Participants n=5 Participants
Age, Continuous	33.6 years STANDARD_DEVIATION 23.49 • n=5 Participants	69.3 years STANDARD_DEVIATION 7.89 • n=7 Participants	40.5 years STANDARD_DEVIATION 25.60 • n=5 Participants
Sex: Female, Male Female	1629 Participants n=5 Participants	403 Participants n=7 Participants	2032 Participants n=5 Participants
Sex: Female, Male Male	1321 Participants n=5 Participants	297 Participants n=7 Participants	1618 Participants n=5 Participants
Region of Enrollment United States	2950 participants n=5 Participants	700 participants n=7 Participants	3650 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 Days post-vaccination

Population: Seroprotection and Booster Responses to Tetanus and Diphtheria were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population.

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.

Outcome measures

Measure	Canadian Td Vaccine Group n=661 Participants Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)	United States Td Vaccine Group n=658 Participants Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria. Tetanus Booster Response	82 Percentage of participants	84 Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria. Diphtheria Booster Response	66 Percentage of participants	63 Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria. Tetanus Post-vaccination Seroprotection	96 Percentage of participants	97 Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria. Diphtheria Post-vaccination Seroprotection	71 Percentage of participants	71 Percentage of participants

SECONDARY outcome

Timeframe: 28 Days post-vaccination

Population: Geometric mean titers were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population

Outcome measures

Measure	Canadian Td Vaccine Group n=661 Participants Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)	United States Td Vaccine Group n=658 Participants Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
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. Tetanus post-vaccination	6.83 Titers Interval 6.01 to 7.77	7.35 Titers Interval 6.54 to 8.26
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. Diphtheria post-vaccination	0.459 Titers Interval 0.371 to 0.567	0.409 Titers Interval 0.332 to 0.504

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-14 days post-vaccination

Population: 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.

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.

Outcome measures

Measure	Canadian Td Vaccine Group n=1450 Participants Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)	United States Td Vaccine Group n=700 Participants Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Injection site redness	299 Participants	132 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Injection site redness (≥ 50 mm)	28 Participants	20 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Injection site swelling	205 Participants	93 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Injection site swelling (≥ 50 mm)	32 Participants	11 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Injection site pain	832 Participants	209 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Injection site pain (require medical care)	7 Participants	5 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Chills	80 Participants	32 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Chills (Incapacitating)	5 Participants	2 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Diarrhea	152 Participants	53 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Diarrhea (≥ 5 episodes)	6 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Fever	95 Participants	40 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Fever (≥ 39.0 °C)	2 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Headache	380 Participants	122 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Headache (Incapacitating)	16 Participants	4 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Malaise	226 Participants	90 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Malaise (Incapacitating)	13 Participants	6 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Muscle weakness	267 Participants	61 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Muscle weakness (Incapacitating)	6 Participants	2 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Nausea	106 Participants	34 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Nausea (Incapacitating)	6 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Pain in joints	201 Participants	74 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Pain in joints (Incapacitating)	7 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Any Vomiting	33 Participants	6 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine. Grade 3 Vomiting (≥ 3 episodes)	6 Participants	1 Participants

Adverse Events

Canadian Td Vaccine Group

Serious events: 58 serious events

Other events: 832 other events

Deaths: 0 deaths

United States Td Vaccine Group

Serious events: 44 serious events

Other events: 209 other events

Deaths: 0 deaths

Serious adverse events

Measure	Canadian Td Vaccine Group n=2950 participants at risk Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)	United States Td Vaccine Group n=700 participants at risk Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Blood and lymphatic system disorders Anaemia	0.07% 2/2950 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Blood and lymphatic system disorders Thrombocytopenia	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Cardiac disorders Acute myocardial infarction	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.29% 2/700 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Cardiac disorders Angina pectoris	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.29% 2/700 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Cardiac disorders Atrial fibrillation	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Cardiac disorders Cardiac failure congestive	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Cardiac disorders Cardio-respiratory arrest	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Cardiac disorders Cardiomyopathy	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Cardiac disorders Myocardial infarction	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.29% 2/700 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Congenital, familial and genetic disorders Moebius II syndrome	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Endocrine disorders Thyroid mass	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Eye disorders Retinal artery occlusion	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Abdominal pain	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Colonic polyp	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Dysphagia	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Ileus	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Inguinal hernia	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Peritonitis	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Rectocele	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
General disorders Chest discomfort	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
General disorders Chest pain	0.07% 2/2950 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.57% 4/700 • Number of events 4 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
General disorders Death	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
General disorders Non-cardiac chest pain	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Hepatobiliary disorders Cholecystitis	0.07% 2/2950 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Hepatobiliary disorders Cholecystitis chronic	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Hepatobiliary disorders Cholelithiasis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Bronchitis	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Bronchitis acute	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Cellulitis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Cystitis	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Diverticulitis	0.07% 2/2950 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Gangrene	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Gastroenteritis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Infectious mononucleosis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Influenza	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Localised infection	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Pneumonia	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Septic shock	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Infections and infestations Viral infection	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Contusion	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Femoral neck fracture	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Fibula fracture	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Head injury	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Hepatic trauma	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Hip Fracture	0.07% 2/2950 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Joint dislocation	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Post procedural haematoma	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Rib fracture	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Tibia fracture	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Wound	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Injury, poisoning and procedural complications Wrist fracture	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Metabolism and nutrition disorders Dehydration	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Metabolism and nutrition disorders Hyponatraemia	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Arthropathy	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.43% 3/700 • Number of events 3 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.43% 3/700 • Number of events 3 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cacer	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.29% 2/700 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraganglion neoplasm malignant	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Nervous system disorders Carotid artery stenosis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Nervous system disorders Cerebrovascular accident	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Nervous system disorders Guillain-Barre syndrome	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Nervous system disorders Post-traumatic headache	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Nervous system disorders Transient ischaemic attack	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Psychiatric disorders Confusional state	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Psychiatric disorders Depression	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Psychiatric disorders Suicide attempt	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Renal and urinary disorders Calculus ureteric	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Renal and urinary disorders Cystocele	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Renal and urinary disorders Haematuria	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Renal and urinary disorders Urethral obstruction	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Renal and urinary disorders Urinary incontinence	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Renal and urinary disorders Urinary retention	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Benign prostatic hyperplasia	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.29% 2/700 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Reproductive system and breast disorders Endometriosis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Reproductive system and breast disorders Pelvic prolapse	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.07% 2/2950 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease exacerbated	0.00% 0/2950 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive airways disease	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.14% 1/700 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Vascular disorders Arterial rupture	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Vascular disorders Deep vein thrombosis	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Vascular disorders Haematoma	0.03% 1/2950 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	0.00% 0/700 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.

Other adverse events

Measure	Canadian Td Vaccine Group n=2950 participants at risk Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)	United States Td Vaccine Group n=700 participants at risk Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
General disorders Injection site pain	58.0% 832/1434 • Number of events 832 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	30.2% 209/693 • Number of events 209 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
General disorders Injection site redness	20.9% 299/1434 • Number of events 299 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	19.0% 132/693 • Number of events 132 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
General disorders Injection site swelling	14.3% 205/1434 • Number of events 205 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	13.4% 93/693 • Number of events 93 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
General disorders Chills	5.6% 80/1434 • Number of events 80 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	4.6% 32/693 • Number of events 32 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Diarrhea	10.6% 152/1434 • Number of events 152 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	7.6% 53/693 • Number of events 53 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
General disorders Pyrexia	6.7% 95/1427 • Number of events 95 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	5.8% 40/687 • Number of events 40 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Nervous system disorders Headache	26.5% 380/1434 • Number of events 380 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	17.6% 122/693 • Number of events 122 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
General disorders Malaise	15.8% 226/1433 • Number of events 226 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	13.0% 90/692 • Number of events 90 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Muscle weakness	18.6% 267/1434 • Number of events 267 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	8.8% 61/692 • Number of events 61 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Gastrointestinal disorders Nausea	7.4% 106/1434 • Number of events 106 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	4.9% 34/692 • Number of events 34 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Pains in joints	14.0% 201/1434 • Number of events 201 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.	10.7% 74/693 • Number of events 74 • Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: RegistryContactUs@sanofipasteur.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER