Trial · NCT00601835

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

NCT00601835, Phase 4, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2011-02-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td. Trials, record NCT00601835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00601835

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td
NCT number: NCT00601835
Status: Completed
Phases: Phase 4
Enrollment: 3,651 participants, actual
Lead sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Diphtheria, Tetanus
Interventions: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine, Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
First posted: 2008-01-28
Last updated: 2016-04-14
Results first posted: 2011-02-18

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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 to Tetanus and Diphtheria were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population.	Percentage of participants	NUMBER
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.	28 Days post-vaccination	Geometric mean titers were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population	Titers	GEOMETRIC_MEAN
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.	0-14 days post-vaccination	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.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.	Canadian Td Vaccine Group	Tetanus Post-vaccination Seroprotection	96		Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.	United States Td Vaccine Group	Tetanus Post-vaccination Seroprotection	97		Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.	Canadian Td Vaccine Group	Diphtheria Post-vaccination Seroprotection	71		Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.	United States Td Vaccine Group	Diphtheria Post-vaccination Seroprotection	71		Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.	Canadian Td Vaccine Group	Tetanus Booster Response	82		Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.	United States Td Vaccine Group	Tetanus Booster Response	84		Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.	Canadian Td Vaccine Group	Diphtheria Booster Response	66		Percentage of participants
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.	United States Td Vaccine Group	Diphtheria Booster Response	63		Percentage of participants
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.	Canadian Td Vaccine Group	Tetanus post-vaccination	6.83	95% Confidence Interval 6.01 to 7.77	Titers
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.	United States Td Vaccine Group	Tetanus post-vaccination	7.35	95% Confidence Interval 6.54 to 8.26	Titers

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Canadian Td Vaccine Group	2,950
Overall Study	STARTED	United States Td Vaccine Group	700
Overall Study	COMPLETED	Canadian Td Vaccine Group	2,890
Overall Study	COMPLETED	United States Td Vaccine Group	686
Overall Study	NOT COMPLETED	Canadian Td Vaccine Group	60
Overall Study	NOT COMPLETED	United States Td Vaccine Group	14

Source ClinicalTrials.gov

Adverse events218

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Injection site pain	General disorders	Canadian Td Vaccine Group	832	1,434	832
other	Injection site pain	General disorders	United States Td Vaccine Group	209	693	209
other	Injection site redness	General disorders	Canadian Td Vaccine Group	299	1,434	299
other	Injection site redness	General disorders	United States Td Vaccine Group	132	693	132
other	Injection site swelling	General disorders	Canadian Td Vaccine Group	205	1,434	205
other	Injection site swelling	General disorders	United States Td Vaccine Group	93	693	93
other	Chills	General disorders	Canadian Td Vaccine Group	80	1,434	80
other	Chills	General disorders	United States Td Vaccine Group	32	693	32
other	Diarrhea	Gastrointestinal disorders	Canadian Td Vaccine Group	152	1,434	152
other	Diarrhea	Gastrointestinal disorders	United States Td Vaccine Group	53	693	53

1 to 10 of 218Source ClinicalTrials.gov

See all 218 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Canadian Td Vaccine Group
Total, all-cause mortality	United States Td Vaccine Group
Total, other adverse events	Canadian Td Vaccine Group	832	2,950
Total, other adverse events	United States Td Vaccine Group	209	700
Total, serious adverse events	Canadian Td Vaccine Group	58	2,950
Total, serious adverse events	United States Td Vaccine Group	44	700

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Canadian Td Vaccine Group vs United States Td Vaccine Group: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00601835

GET https://conductscience.org/api/trials/v1/NCT00601835/results?page=2

API reference For AI assistants