Trial · NCT01439165
Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
NCT01439165, Phase 4, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2017-10-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose. Trials, record NCT01439165. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01439165
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
- NCT number
- NCT01439165
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,330 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Tetanus, Diphtheria, Pertussis, Whooping Cough
- Interventions
- Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine, Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
- First posted
- 2011-09-23
- Last updated
- 2022-04-28
- Results first posted
- 2017-10-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Diphtheria and Tetanus Seroprotection | 1 month post-booster vaccination | Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL. |
| Primary | Percentage of Participants With Diphtheria and Tetanus Booster Response | 1 month post-booster vaccination | Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. A booster response was defined as a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with pre-vaccination antibody concentrations ≤2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus. If the pre vaccination antibody concentrations were \> 2.56 IU/mL for diphtheria and \> 2.7 IU/mL for tetanus, then a 2-fold increase in response rate was defined as a booster response. |
| Primary | Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies | 1 month post-booster vaccination | Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin (FHA), Pertactin, Fimbriae types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Anti-pertussis GMCs further to Adacel vaccination was compared to an historical control group with Daptacel (NCT00255047 for pertussis toxoid and PMID 8538705 for FHA, Pertactin and Fimbriae) since Td Adsorbed Vaccine does not contain any pertussis antigens. |
| Primary | Percentage of Subjects With Pertussis Antigen Booster Response | 1 month post-booster vaccination | Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin \[FHA\], Pertactin, Fimbriae (types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Booster response is defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times if the pre-vaccination concentration is above the cutoff value, or at least 4 times if it is at or below the cutoff value. Anti-pertussis toxoid booster response rates further to Adacel vaccination was compared to an expected booster rates based on study Td506 (PMID 15933223) since Td Adsorbed Vaccine does not contain any pertussis antigens. |
| Secondary | Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions | Day 0 up to Day 7 post-vaccination | Injection site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Significant, prevents daily activity. Erythema and Swelling, \>100 mm. Grade 3 Systemic reactions: Fever, ≥39°C or ≥102.1 F; Headache, Malaise, and Myalgia, Significant; prevents daily activity. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Diphtheria and Tetanus Seroprotection | 1 month post-booster vaccination | Seroprotection was assessed in the Per Protocol Analysis Set. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Diphtheria and Tetanus Booster Response | 1 month post-booster vaccination | Booster response rates were assessed in the Per Protocol Analysis Set. | Percentage of participants | NUMBER |
| PRIMARY | Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies | 1 month post-booster vaccination | Geometric mean concentrations were assessed in the Per Protocol Analysis Set. | Concentrations (1/dil) | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Subjects With Pertussis Antigen Booster Response | 1 month post-booster vaccination | Booster response rate was assessed in the Per protocol analysis set | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions | Day 0 up to Day 7 post-vaccination | Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Diphtheria and Tetanus Seroprotection | Adacel Vaccine | Tetanus | 100.0 | Percentage of participants | |
| Percentage of Participants With Diphtheria and Tetanus Seroprotection | Td Adsorbed Vaccine | Tetanus | 100.0 | Percentage of participants | |
| Percentage of Participants With Diphtheria and Tetanus Seroprotection | Adacel Vaccine | Diphtheria | 99.8 | Percentage of participants | |
| Percentage of Participants With Diphtheria and Tetanus Seroprotection | Td Adsorbed Vaccine | Diphtheria | 99.4 | Percentage of participants | |
| Percentage of Participants With Diphtheria and Tetanus Booster Response | Adacel Vaccine | Tetanus | 74.5 | Percentage of participants | |
| Percentage of Participants With Diphtheria and Tetanus Booster Response | Td Adsorbed Vaccine | Tetanus | 81.6 | Percentage of participants | |
| Percentage of Participants With Diphtheria and Tetanus Booster Response | Adacel Vaccine | Diphtheria | 83.2 | Percentage of participants | |
| Percentage of Participants With Diphtheria and Tetanus Booster Response | Td Adsorbed Vaccine | Diphtheria | 84.1 | Percentage of participants | |
| Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies | Adacel Vaccine | Pertussis Toxoid | 102 | 95% Confidence Interval 94.9 to 110 | Concentrations (1/dil) |
| Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies | Adacel Vaccine | FHA | 209 | 95% Confidence Interval 200 to 217 | Concentrations (1/dil) |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 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 | 1,002 | |
| Overall Study | STARTED | Td Adsorbed Vaccine | 328 | |
| Overall Study | COMPLETED | Adacel Vaccine | 981 | |
| Overall Study | COMPLETED | Td Adsorbed Vaccine | 326 | |
| Overall Study | NOT COMPLETED | Adacel Vaccine | 21 | |
| Overall Study | NOT COMPLETED | Td Adsorbed Vaccine | 2 |
Source ClinicalTrials.gov
Adverse events30
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 | 855 | 999 | 855 |
| other | Injection site Pain | General disorders | Td Adsorbed Vaccine | 284 | 328 | 284 |
| other | Injection site Erythema | General disorders | Adacel Vaccine | 63 | 999 | 63 |
| other | Injection site Erythema | General disorders | Td Adsorbed Vaccine | 18 | 328 | 18 |
| other | Injection site Swelling | General disorders | Adacel Vaccine | 68 | 999 | 68 |
| other | Injection site Swelling | General disorders | Td Adsorbed Vaccine | 26 | 328 | 26 |
| other | Headache | Nervous system disorders | Adacel Vaccine | 407 | 999 | 407 |
| other | Headache | Nervous system disorders | Td Adsorbed Vaccine | 127 | 328 | 127 |
| other | Malaise | General disorders | Adacel Vaccine | 327 | 999 | 327 |
| other | Malaise | General disorders | Td Adsorbed Vaccine | 100 | 328 | 100 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adacel Vaccine | 0 | 999 |
| Total, all-cause mortality | Td Adsorbed Vaccine | 0 | 328 |
| Total, other adverse events | Adacel Vaccine | 855 | 999 |
| Total, other adverse events | Td Adsorbed Vaccine | 284 | 328 |
| Total, serious adverse events | Adacel Vaccine | 8 | 999 |
| Total, serious adverse events | Td Adsorbed Vaccine | 1 | 328 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adacel Vaccine vs Td Adsorbed Vaccine: deaths from any cause | Trial comparisons |
| Adacel Vaccine vs Td Adsorbed Vaccine: serious adverse events | 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/NCT01439165
GET https://conductscience.org/api/trials/v1/NCT01439165/results?page=2