Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-6774 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.
Primary objective:
Observational objectives:
Participants will be randomized in a 1:1 ratio to receive either Adacel or Boostrix vaccine.
Subjects will be monitored for immediate reactions for 15 minutes post-vaccination. Unsolicited adverse events and serious adverse events will be collected from Visit 1 through Visit 2.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adacel® Vaccine Group | Experimental | Participants randomized to receive a single dose of Adacel® vaccine |
|
| Boostrix® Vaccine Group | Active Comparator | Participants randomized to receive a single dose of Boostrix® vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL | Day 0 (pre-vaccination) to Day 28 (post-vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test | Day 0 (pre-vaccination) to Day 28 post-vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento | California | 95816 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31301919 | Derived | Decker MD, Greenberg DP, Johnson DR, Pool V. Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP. Vaccine. 2019 Aug 14;37(35):5003-5008. doi: 10.1016/j.vaccine.2019.07.015. Epub 2019 Jul 10. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
A total of 423 participants that met all of the inclusion and none of the exclusion criteria were randomized, 422 were vaccinated in this study.
The study participants were enrolled from 20 June 2012 to 10 September 2012 at 8 centers in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adacel® Vaccine Group | Participants received a single dose of Adacel® vaccine |
| FG001 | BOOSTRIX® Vaccine Group | Participants received a single dose of BOOSTRIX® vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®) | Biological | 0.5 mL, Intramuscular |
|
|
| Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine |
Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration >2.56 IU/mL for diphtheria and >2.7 IU/mL for tetanus. Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ. |
| Day 28 post-vaccination |
| Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by Enzyme-linked immunosorbent assay (ELISA) | Day 0 (pre-vaccination) to Day 28 post-vaccination |
| Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration >93 EU/mL for PT, >170 EU/mL for FHA, >115 EU/mL for PRN, or >285 EU/mL for FIM. Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer \ | Day 28 post-vaccination |
| Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs. | Up to 15 minutes post-vaccination |
| Bardstown |
| Kentucky |
| 40040 |
| United States |
| Woburn | Massachusetts | 07801 | United States |
| Cleveland | Ohio | 44121 | United States |
| Barnwell | South Carolina | 29812 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Salt Lake City | Utah | 84124 | United States |
| Vienna | Virginia | 22180 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adacel® Vaccine Group | Participants received a single dose of Adacel® vaccine |
| BG001 | BOOSTRIX® Vaccine Group | Participants received a single dose of BOOSTRIX® vaccine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| 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 | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL | The antibody responses to tetanus and diphtheria components were determined in the Per-Protocol Analysis Set. | Posted | Number | Participants | Day 0 (pre-vaccination) to Day 28 (post-vaccination) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test | The geometric mean concentrations of tetanus and diphtheria antibodies were determined in the Per Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) to Day 28 post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration >2.56 IU/mL for diphtheria and >2.7 IU/mL for tetanus. Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ. | Booster response against tetanus and diphtheria components were determined in the Per-Protocol Analysis Set. | Posted | Number | Participants | Day 28 post-vaccination |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by Enzyme-linked immunosorbent assay (ELISA) | Geometric mean concentrations of the Pertussis antibodies were determined in the Per-Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) to Day 28 post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration >93 EU/mL for PT, >170 EU/mL for FHA, >115 EU/mL for PRN, or >285 EU/mL for FIM. Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer \ | Booster response against Pertussis antibodies were determined in the Per-Protocol Analysis Set. | Posted | Number | Participants | Day 28 post-vaccination |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs. | Number of participants reporting immediate unsolicited adverse events was determined in all participants in the Safety Analysis Set. | Posted | Number | Participants | Up to 15 minutes post-vaccination |
|
|
Adverse event data were collected from Day 0 up to Day 28 post-vaccination.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adacel® Vaccine Group | Participants received a single dose of Adacel® vaccine | 0 | 211 | 58 | 211 | ||
| EG001 | BOOSTRIX® Vaccine Group | Participants received a single dose of BOOSTRIX® vaccine | 0 | 211 | 70 | 211 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| C509326 | adacel |
| C505143 | Boostrix |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Diphtheria (pre-vaccination) ≥0.1 IU/mL |
|
| Diphtheria (post-vaccination) ≥ 0.1 IU/mL |
|
| Tetanus (pre-vaccination) ≥ 1.0 IU/mL |
|
| Tetanus (post-vaccination) ≥ 1.0 IU/mL |
|
| Diphtheria (pre-vaccination) ≥1.0 IU/mL |
|
| Diphtheria (post-vaccination) ≥1.0 IU/mL |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|