Trial · NCT00457249
A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
NCT00457249, Phase 4, Completed, Sanofi; results first posted 2012-10-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older. Trials, record NCT00457249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00457249
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
- NCT number
- NCT00457249
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,564 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Pertussis, Tetanus, Diphtheria
- Interventions
- ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed, DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
- First posted
- 2007-04-06
- Last updated
- 2012-10-19
- Results first posted
- 2012-10-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Day 35 post-vaccination | |
| Primary | Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®. | Day 35 post-vaccination | Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL. |
| Primary | Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine. | Day 35 post-vaccination | Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value. |
| Other | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Day 0 up to 14 days post-vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Day 35 post-vaccination | GMTs and their 95% Confidence Intervals were assessed in the per-protocol population. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®. | Day 35 post-vaccination | Seroprotection was assessed in the per-protocol population | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine. | Day 35 post-vaccination | Booster response was assessed in the per-protocol population. | Percentage of Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Day 0 up to 14 days post-vaccination | Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | ADACEL® Vaccine Group | Tetanus (Pre-vaccination: N = 1089; 368) | 0.501 | 95% Confidence Interval 0.445 to 0.564 | Titers |
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | DECAVAC® Vaccine Group | Tetanus (Pre-vaccination: N = 1089; 368) | 0.451 | 95% Confidence Interval 0.365 to 0.558 | Titers |
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | ADACEL® Vaccine Group | Tetanus (Post-vaccination: N = 1075; 368) | 8.43 | 95% Confidence Interval 7.78 to 9.14 | Titers |
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | DECAVAC® Vaccine Group | Tetanus (Post-vaccination: N = 1075; 368) | 7.23 | 95% Confidence Interval 6.23 to 8.38 | Titers |
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | ADACEL® Vaccine Group | Diphtheria (Pre-vaccination: N = 1092; 370) | 0.049 | 95% Confidence Interval 0.043 to 0.056 | Titers |
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | DECAVAC® Vaccine Group | Diphtheria (Pre-vaccination: N = 1092; 370) | 0.056 | 95% Confidence Interval 0.045 to 0.071 | Titers |
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | ADACEL® Vaccine Group | Diphtheria (Post-vaccination: N = 1093; 371) | 0.570 | 95% Confidence Interval 0.489 to 0.665 | Titers |
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | DECAVAC® Vaccine Group | Diphtheria (Post-vaccination: N = 1093; 371) | 0.505 | 95% Confidence Interval 0.401 to 0.636 | Titers |
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | ADACEL® Vaccine Group | Pertussis Toxoid (Pre-vaccination: N = 1013; 345) | 10.6 | 95% Confidence Interval 9.81 to 11.5 | Titers |
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | DECAVAC® Vaccine Group | Pertussis Toxoid (Pre-vaccination: N = 1013; 345) | 12.7 | 95% Confidence Interval 11.1 to 14.5 | Titers |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ADACEL® Vaccine Group | 1,170 | |
| Overall Study | STARTED | DECAVAC® Vaccine Group | 391 | |
| Overall Study | COMPLETED | ADACEL® Vaccine Group | 1,158 | |
| Overall Study | COMPLETED | DECAVAC® Vaccine Group | 389 | |
| Overall Study | NOT COMPLETED | ADACEL® Vaccine Group | 12 | |
| Overall Study | NOT COMPLETED | DECAVAC® Vaccine Group | 2 |
Source ClinicalTrials.gov
Adverse events154
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 | ADACEL® Vaccine Group | 496 | 1,170 | |
| other | Injection site pain | General disorders | DECAVAC® Vaccine Group | 163 | 391 | |
| other | Injection site erythema | General disorders | ADACEL® Vaccine Group | 280 | 1,170 | |
| other | Injection site erythema | General disorders | DECAVAC® Vaccine Group | 86 | 391 | |
| other | Injection site swelling | General disorders | ADACEL® Vaccine Group | 209 | 1,170 | |
| other | Injection site swelling | General disorders | DECAVAC® Vaccine Group | 59 | 391 | |
| other | Headache | Nervous system disorders | ADACEL® Vaccine Group | 209 | 1,170 | |
| other | Headache | Nervous system disorders | DECAVAC® Vaccine Group | 76 | 391 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | ADACEL® Vaccine Group | 327 | 1,170 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | DECAVAC® Vaccine Group | 108 | 391 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ADACEL® Vaccine Group | ||
| Total, all-cause mortality | DECAVAC® Vaccine Group | ||
| Total, other adverse events | ADACEL® Vaccine Group | 615 | 1,170 |
| Total, other adverse events | DECAVAC® Vaccine Group | 200 | 391 |
| Total, serious adverse events | ADACEL® Vaccine Group | 49 | 1,170 |
| Total, serious adverse events | DECAVAC® Vaccine Group | 20 | 391 |
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 |
|---|
| ADACEL® Vaccine Group vs DECAVAC® 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.
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/NCT00457249
GET https://conductscience.org/api/trials/v1/NCT00457249/results?page=2