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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1124-7671 | Other Identifier | WHO |
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This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan.
Primary Objective:
Secondary Objective:
All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and undergo immunogenicity assessment from blood samples provided prior to, and 28 days post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis | Biological | 0.5 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® | Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination. | Day 28 post-vaccination |
| Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® | Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL. Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL. | Day 28 post-vaccination |
| Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL® | Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2) | Day 28 post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL® | Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL. | Day 0 pre-vaccination |
| Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL® |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur K.K | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi | Japan | |||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 43 participants that met all the inclusion criteria but none of the exclusion criteria were enrolled and vaccinated in the study.
The study participants were enrolled from 12 September through 14 October 2012 in 3 clinic centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL. |
| Day 0 (pre-vaccination) and day 28 post-vaccination |
| Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL® | Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL. | Day 0 (pre-vaccination) and day 28 post-vaccination |
| Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL® | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL® | Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2) | Day 28 post-vaccination |
| Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® | Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm. Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity. | Day 0 up to Day 7 post-vaccination |
| Ibaraki |
| Japan |
| Nagano | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0. |
| 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 | Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® | Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination. | Seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set | Posted | Number | Percentage of Participants | Day 28 post-vaccination |
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| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® | Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL. Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL. | Booster response to diphtheria and tetanus antigens were determined in the Immunology Analysis Set | Posted | Number | Percentage of Participants | Day 28 post-vaccination |
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| Primary | Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL® | Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2) | Booster response to pertussis antigens were determined in the Immunology Analysis Set | Posted | Number | Percentage of Participants | Day 28 post-vaccination |
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| Other Pre-specified | Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL® | Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL. | Pre-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set | Posted | Number | Percentage of Participants | Day 0 pre-vaccination |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL® | Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL. | Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set. | Posted | Number | Percentage of Participants | Day 0 (pre-vaccination) and day 28 post-vaccination |
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| Other Pre-specified | Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL® | Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL. | Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set | Posted | Number | Percentage of Participants | Day 0 (pre-vaccination) and day 28 post-vaccination |
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| Other Pre-specified | Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL® | Pre and post vaccination geometric mean concentrations to Diphtheria and Tetanus antigens were determined in the Immunology Analysis Set | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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| Other Pre-specified | Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® | Pre and post vaccination geometric mean concentrations to pertussis antibodies were determined in the Immunology Analysis Set | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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| Other Pre-specified | Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL® | Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2) | Booster response to pertussis antigens were determined in the Immunology Analysis Set | Posted | Number | Percentage of Participants | Day 28 post-vaccination |
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| Other Pre-specified | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® | Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm. Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity. | Solicited injection site and systemic reactions were assessed in the Safety Analysis Set | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
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Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-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 | Study Group | Participants received a single booster dose of Tdap vaccine on Day 0. | 0 | 43 | 39 | 43 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Solicited injection site Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Solicited injection site Erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Solicited injection site Swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Fever | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Myalgia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Non-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 |
|---|---|
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| C509326 | adacel |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Pertussis toxoid (pre-vaccination) |
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| Pertussis toxoid (post-vaccination) |
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| Filamentous hemagglutinin (pre-vaccination) |
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| Filamentous hemagglutinin (post-vaccination) |
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| Pertactin (pre-vaccination) |
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| Pertactin (post-vaccination) |
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| Fimbriae types 2 and 3 (pre-vaccination) |
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| Fimbriae types 2 and 3 (post-vaccination) |
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