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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1115-6619 | Other Identifier | WHO |
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The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age.
Primary Objectives:
Secondary Objective:
Study participants will receive a single dose of study vaccine and will then be monitored for safety from the day of vaccination for up to 30 days post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adacel Vaccine Group 1 | Experimental | Participants enrolled at 10 to < 11 years of age |
|
| Adacel Vaccine Group 2 | Experimental | Participants enrolled at 11 to < 12 years of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | 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). | Day 30 post-vaccination |
| Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine | 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. | 30 days post-vaccination |
| Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine | 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. | 30 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine | 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. | Day 0 (pre-vaccination) and 30 days post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler | Arizona | 85224 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25230939 | Derived | Marshall GS, Pool V, Greenberg DP, Johnson DR, Sheng X, Decker MD. Safety and immunogenicity of tetanus-diphtheria-acellular pertussis vaccine administered to children 10 or 11 years of age. Clin Vaccine Immunol. 2014 Nov;21(11):1560-4. doi: 10.1128/CVI.00474-14. Epub 2014 Sep 17. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 1302 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Study participants were enrolled from 07 March 2011 to 19 May 2011 at 36 clinical centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants 10 to <11 Years of Age | Participants received 1 dose of Adacel® vaccine at Visit 1. |
| FG001 | Participants 11 to <12 Years of Age | Participants received 1 dose of Adacel® vaccine at Visit 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed | Biological | 0.5 mL, Intramuscular |
|
|
| Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine | 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). | Day 0 (pre-vaccination) and Day 30 post-vaccination |
| Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine | 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. | Day 0 up to Day 7 post-vaccination |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Little Rock | Arkansas | 72205 | United States |
| Sacramento | California | 95816 | United States |
| Longmont | Colorado | 80501 | United States |
| Norwich | Connecticut | 06360 | United States |
| Miami Beach | Florida | 33141 | United States |
| Marietta | Georgia | 30062 | United States |
| Woodstock | Georgia | 30189 | United States |
| Bardstown | Kentucky | 40040 | United States |
| Crestview Hills | Kentucky | 41017 | United States |
| Louisville | Kentucky | 40202 | United States |
| Madisonville | Kentucky | 42431 | United States |
| Haughton | Louisiana | 71037 | United States |
| Metairie | Louisiana | 70006 | United States |
| Woburn | Massachusetts | 01801 | United States |
| Plymouth | Minnesota | 55441 | United States |
| Rochester | New York | 14609 | United States |
| Cleveland | Ohio | 44121 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Barnwell | South Carolina | 29812 | United States |
| Rapid City | South Dakota | 57701 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Austin | Texas | 78705 | United States |
| Fort Worth | Texas | 76135 | United States |
| San Antonio | Texas | 78205 | United States |
| Orem | Utah | 84057 | United States |
| Salt Lake City | Utah | 84124 | United States |
| South Jordan | Utah | 84095 | United States |
| Midlothian | Virginia | 23113 | United States |
| Vienna | Virginia | 22180 | United States |
| Spokane | Washington | 99202 | United States |
| Marshfield | Wisconsin | 54449 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants 10 to <11 Years of Age | Participants received 1 dose of Adacel® vaccine at Visit 1. |
| BG001 | Participants 11 to <12 Years of Age | Participants received 1 dose of Adacel® vaccine at Visit 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine | 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). | Geometric mean titers were assessed in the Per-protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilutions) | Day 30 post-vaccination |
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| Primary | Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine | 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. | Anti-pertussis booster response were assessed in the Per-protocol Analysis Set. | Posted | Number | Percentage of participants | 30 days post-vaccination |
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| Primary | Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine | 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. | Anti-Tetanus and anti-Diphtheria booster responses were assessed in the Per-protocol Analysis Set. | Posted | Number | Percentage of participants | 30 days post-vaccination |
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| Secondary | Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine | 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. | Seroprotection rates were assessed in the Per Protocol Analysis Set. | Posted | Number | Percentage of participants | Day 0 (pre-vaccination) and 30 days post-vaccination |
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| Secondary | Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine | 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). | Geometric mean titers were assessed in the Per Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilutions) | Day 0 (pre-vaccination) and Day 30 post-vaccination |
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| Secondary | Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine | 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. | Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. | Posted | Number | Percentage of participants | Day 0 up to Day 7 post-vaccination |
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Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants 10 to <11 Years of Age | Participants received 1 dose of Adacel® vaccine at Visit 1. | 0 | 651 | 521 | 651 | ||
| EG001 | Participants 11 to <12 Years of Age | Participants received 1 dose of Adacel® vaccine at Visit 1. | 1 | 651 | 522 | 651 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-site Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Injection-site Erythema | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Injection-site Swelling | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C509326 | adacel |
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| >=65 years |
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| Male |
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| Anti-Pertactin (N=613, 607) |
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| Anti-Fimbriae types 2 & 3 (N=606, 605) |
|
| GMT Ratio |
| 1.03 |
| 2-Sided |
| 95 |
| 0.944 |
| 1.13 |
| Yes |
| Non-Inferiority or Equivalence |
A two-sided 95% CI was constructed around each of the ratios: anti-Filamentous hemagglutinin (FHA) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025. |
| GMT Ratio | 1.05 | 2-Sided | 95 | 0.928 | 1.18 | Yes | Non-Inferiority or Equivalence | A two-sided 95% CI was constructed around each of the ratios: Anti-Pertactin (PRN) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025. |
| GMT Ratio | 0.882 | 2-Sided | 95 | 0.731 | 1.06 | Yes | Non-Inferiority or Equivalence | A two-sided 95% CI was constructed around each of the ratios: anti-Fimbriae types 2 and 3 (FIM) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025. |
| Participants |
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