Trial · NCT01311557
Study of Adacel® Vaccine Administered to Persons 10 Years of Age
NCT01311557, Phase 4, Completed, Sanofi; results first posted 2016-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Adacel® Vaccine Administered to Persons 10 Years of Age. Trials, record NCT01311557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01311557
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Adacel® Vaccine Administered to Persons 10 Years of Age
- NCT number
- NCT01311557
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,302 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Tetanus, Diphtheria, Pertussis
- Interventions
- Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed, Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
- First posted
- 2011-03-09
- Last updated
- 2016-04-08
- Results first posted
- 2016-04-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Day 30 post-vaccination | Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA). |
| Primary | Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine | 30 days post-vaccination | Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], fimbriae types 2 and 3 \[FIM\]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were \> 93 EU/mL for PT, \> 170 EU/mL for FHA, \> 115 EU mL for PRN, or \> 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response. |
| Primary | Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine | 30 days post-vaccination | Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were \> 2.56 EU/mL for diphtheria or \> 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response. |
| Secondary | Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine | Day 0 (pre-vaccination) and 30 days post-vaccination | Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL. |
| Secondary | Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine | Day 0 (pre-vaccination) and Day 30 post-vaccination | Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA). |
| Secondary | Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine | Day 0 up to Day 7 post-vaccination | Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Day 30 post-vaccination | Geometric mean titers were assessed in the Per-protocol Analysis Set. | Titers (1/dilutions) | GEOMETRIC_MEAN |
| PRIMARY | Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine | 30 days post-vaccination | Anti-pertussis booster response were assessed in the Per-protocol Analysis Set. | Percentage of participants | NUMBER |
| PRIMARY | Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine | 30 days post-vaccination | Anti-Tetanus and anti-Diphtheria booster responses were assessed in the Per-protocol Analysis Set. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine | Day 0 (pre-vaccination) and 30 days post-vaccination | Seroprotection rates were assessed in the Per Protocol Analysis Set. | Percentage of participants | NUMBER |
| SECONDARY | Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine | Day 0 (pre-vaccination) and Day 30 post-vaccination | Geometric mean titers were assessed in the Per Protocol Analysis Set. | Titers (1/dilutions) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine | 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 group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Participants 10 to <11 Years of Age | Anti-Pertussis toxoid (N=577, 566) | 30.1 | 95% Confidence Interval 28.0 to 32.4 | Titers (1/dilutions) |
| Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Participants 11 to <12 Years of Age | Anti-Pertussis toxoid (N=577, 566) | 32.0 | 95% Confidence Interval 29.6 to 34.7 | Titers (1/dilutions) |
| Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Participants 10 to <11 Years of Age | Anti-Filamentous hemagglutinin, Day 30(N=613, 608) | 232 | 95% Confidence Interval 218 to 247 | Titers (1/dilutions) |
| Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Participants 11 to <12 Years of Age | Anti-Filamentous hemagglutinin, Day 30(N=613, 608) | 225 | 95% Confidence Interval 211 to 239 | Titers (1/dilutions) |
| Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Participants 10 to <11 Years of Age | Anti-Pertactin (N=613, 607) | 464 | 95% Confidence Interval 426 to 506 | Titers (1/dilutions) |
| Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Participants 11 to <12 Years of Age | Anti-Pertactin (N=613, 607) | 444 | 95% Confidence Interval 408 to 482 | Titers (1/dilutions) |
| Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Participants 10 to <11 Years of Age | Anti-Fimbriae types 2 & 3 (N=606, 605) | 477 | 95% Confidence Interval 413 to 550 | Titers (1/dilutions) |
| Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | Participants 11 to <12 Years of Age | Anti-Fimbriae types 2 & 3 (N=606, 605) | 540 | 95% Confidence Interval 478 to 611 | Titers (1/dilutions) |
| Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine | Participants 10 to <11 Years of Age | Anti-Pertussis toxoid (N=554, 549) | 56.7 | Percentage of participants | |
| Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine | Participants 11 to <12 Years of Age | Anti-Pertussis toxoid (N=554, 549) | 56.1 | Percentage of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants 10 to <11 Years of Age | 651 | |
| Overall Study | STARTED | Participants 11 to <12 Years of Age | 651 | |
| Overall Study | COMPLETED | Participants 10 to <11 Years of Age | 646 | |
| Overall Study | COMPLETED | Participants 11 to <12 Years of Age | 645 | |
| Overall Study | NOT COMPLETED | Participants 10 to <11 Years of Age | 5 | |
| Overall Study | NOT COMPLETED | Participants 11 to <12 Years of Age | 6 |
Source ClinicalTrials.gov
Adverse events14
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 | Participants 10 to <11 Years of Age | 521 | 651 | 521 |
| other | Injection-site Pain | General disorders | Participants 11 to <12 Years of Age | 522 | 651 | 522 |
| other | Injection-site Erythema | General disorders | Participants 10 to <11 Years of Age | 254 | 651 | 254 |
| other | Injection-site Erythema | General disorders | Participants 11 to <12 Years of Age | 248 | 651 | 248 |
| other | Injection-site Swelling | General disorders | Participants 10 to <11 Years of Age | 227 | 651 | 227 |
| other | Injection-site Swelling | General disorders | Participants 11 to <12 Years of Age | 216 | 651 | 216 |
| other | Headache | Nervous system disorders | Participants 10 to <11 Years of Age | 213 | 651 | 213 |
| other | Headache | Nervous system disorders | Participants 11 to <12 Years of Age | 243 | 651 | 243 |
| other | Malaise | General disorders | Participants 10 to <11 Years of Age | 169 | 651 | 169 |
| other | Malaise | General disorders | Participants 11 to <12 Years of Age | 189 | 651 | 189 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants 10 to <11 Years of Age | ||
| Total, all-cause mortality | Participants 11 to <12 Years of Age | ||
| Total, other adverse events | Participants 10 to <11 Years of Age | 521 | 651 |
| Total, other adverse events | Participants 11 to <12 Years of Age | 522 | 651 |
| Total, serious adverse events | Participants 10 to <11 Years of Age | 0 | 651 |
| Total, serious adverse events | Participants 11 to <12 Years of Age | 1 | 651 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25230939 | DERIVED |
Source PubMed
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 |
|---|
| Participants 10 to <11 Years of Age vs Participants 11 to <12 Years of Age: 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/NCT01311557
GET https://conductscience.org/api/trials/v1/NCT01311557/results?page=2