Diphtheria, Tetanus
Conditions
Keywords
Diphtheria, Tetanus
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.
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.
Interventions
BIOLOGICALTetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
0.5 mL, Intramuscular, single dose
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 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.
Participants by arm
| Arm | Count |
|---|---|
| Canadian Td Vaccine Group Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™) | 2,950 |
| United States Td Vaccine Group Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®) | 700 |
| Total | 3,650 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 37 | 5 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Relocate | 12 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 6 |
Baseline characteristics
| Characteristic | United States Td Vaccine Group | Canadian Td Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1501 Participants | 1501 Participants |
| Age, Categorical >=65 years | 443 Participants | 449 Participants | 892 Participants |
| Age, Categorical Between 18 and 65 years | 257 Participants | 1000 Participants | 1257 Participants |
| Age, Continuous | 69.3 years STANDARD_DEVIATION 7.89 | 33.6 years STANDARD_DEVIATION 23.49 | 40.5 years STANDARD_DEVIATION 25.6 |
| Region of Enrollment United States | 700 participants | 2950 participants | 3650 participants |
| Sex: Female, Male Female | 403 Participants | 1629 Participants | 2032 Participants |
| Sex: Female, Male Male | 297 Participants | 1321 Participants | 1618 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 832 / 2,950 | 209 / 700 |
| serious Total, serious adverse events | 58 / 2,950 | 44 / 700 |
Outcome results
Primary
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.
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
Population: Seroprotection and Booster Responses to Tetanus and Diphtheria were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| United States Td Vaccine Group | Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria. | Diphtheria Booster Response | 63 Percentage of participants |
| United States Td Vaccine Group | Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria. | Tetanus Post-vaccination Seroprotection | 97 Percentage of participants |
| United States Td Vaccine Group | Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria. | Tetanus Booster Response | 84 Percentage of participants |
| United States Td Vaccine Group | 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 |
Secondary
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.
Time frame: 28 Days post-vaccination
Population: Geometric mean titers were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| United States Td Vaccine Group | 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 | 7.35 Titers |
| United States Td Vaccine Group | 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 | 0.409 Titers |
Other Pre-specified
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| Canadian Td Vaccine Group | 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 |
| United States Td Vaccine Group | 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 | 6 Participants |
| United States Td Vaccine Group | 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 | 209 Participants |
| United States Td Vaccine Group | 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 | 122 Participants |
| United States Td Vaccine Group | 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) | 5 Participants |
| United States Td Vaccine Group | 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 | 34 Participants |
| United States Td Vaccine Group | 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 | 132 Participants |
| United States Td Vaccine Group | 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) | 4 Participants |
| United States Td Vaccine Group | 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) | 20 Participants |
| United States Td Vaccine Group | 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) | 1 Participants |
| United States Td Vaccine Group | 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 | 93 Participants |
| United States Td Vaccine Group | 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 | 90 Participants |
| United States Td Vaccine Group | 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) | 11 Participants |
| United States Td Vaccine Group | 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) | 1 Participants |
| United States Td Vaccine Group | 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 | 32 Participants |
| United States Td Vaccine Group | 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) | 6 Participants |
| United States Td Vaccine Group | 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) | 2 Participants |
| United States Td Vaccine Group | 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) | 1 Participants |
| United States Td Vaccine Group | 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 | 53 Participants |
| United States Td Vaccine Group | 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 | 61 Participants |
| United States Td Vaccine Group | 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) | 1 Participants |
| United States Td Vaccine Group | 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 | 74 Participants |
| United States Td Vaccine Group | 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 | 40 Participants |
| United States Td Vaccine Group | 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) | 2 Participants |
| United States Td Vaccine Group | 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) | 1 Participants |