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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1112-8558 | Other Identifier | WHO |
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This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".
The study objective is to assess within 30 days post-administration, the safety of ADACELâ„¢ administered under the real clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADACELâ„¢:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined | Biological | 0.5 mL, intramuscular (IM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacelâ„¢ | All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. | 30 days post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacelâ„¢ | Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. | 30 days post-vaccination |
| Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacelâ„¢ |
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 |
|---|---|---|---|---|---|---|
| Jung-gu | Incheon | South Korea | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Case report forms were retrieved from a total of 687 participants during the 6 years post marketing surveillance study; 659 participants were included in the safety analysis.
The Post Marketing Surveillance period was from 23 June 2009 to 22 June 2015 at 7 clinic centers in South Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Subjects | Participants who had returned case report forms and included in the safety analysis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Subjects | Participants who had returned case report forms and included in the safety analysis. |
| 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 |
| 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 Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacelâ„¢ | All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. | Safety events were assessed in the Safety Analysis Set. | Posted | Number | Participants | 30 days post-vaccination |
|
|
Adverse event data were collected within 30 days of each vaccination during the 6 years post marketing surveillance period.
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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 Subjects | Participants who had returned case report forms and included in the safety analysis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-site Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| C509326 | adacel |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. |
| 30 days post-vaccination |
| Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities. All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period. | 7 days post-vaccination |
| Seoul |
| South Korea |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
|
| Other Pre-specified | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacelâ„¢ | Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. | Safety events were assessed in the Safety Analysis Set. | Posted | Number | Participants | 30 days post-vaccination |
|
|
|
| Other Pre-specified | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacelâ„¢ | All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. | Safety events were assessed in the Safety Analysis Set. | Posted | Number | Participants | 30 days post-vaccination |
|
|
|
| Other Pre-specified | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities. All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period. | Safety events were assessed in the Safety Analysis Set. | Posted | Number | Number of Events | 7 days post-vaccination |
|
|
|
| 1 |
| 659 |
| 108 |
| 659 |
| Injection-site Erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection-site Swelling | General disorders | MedDRA 17.0 | 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
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|
|
| Coughing |
|
| Rhinorrhoea |
|
| Nasopharyngitis |
|
| Pharyngitis |
|
| Throat sore |
|
| Asthma |
|
| Nasal obstruction |
|
| Sputum |
|
| Tonsillitis |
|
| Malaise |
|
| Influenza |
|
| Pain axillary |
|
| Purulent discharge |
|
| Gastritis |
|
| Gastritis acute |
|
| Gastroenteritis |
|
| Enteritis |
|
| Dyspepsia |
|
| Dermatitis atopic |
|
| Furuncle (excluding genital) |
|
| Rash impetiginous |
|
| Sweating increased |
|
| Dizziness |
|
| Allergic conjunctivitis |
|
| Conjunctivitis |
|
| ALT increased |
|
| AST increased |
|
| Hand foot mouth disease |
|
| Title | Measurements |
|---|
|
| Injection-site Itching |
|
| Injection-site Bruising |
|
| Myalgia |
|
| Arthralgia |
|
| Bronchitis |
|
| Rhinitis |
|
| Coughing |
|
| Rhinorrhoea |
|
| Nasopharyngitis |
|
| Pharyngitis |
|
| Throat sore |
|
| Asthma |
|
| Nasal obstruction |
|
| Sputum |
|
| Tonsillitis |
|
| Malaise |
|
| Fever |
|
| Influenza |
|
| Knee pain |
|
| Pain axillary |
|
| Purulent discharge |
|
| Gastritis |
|
| Gastritis acute |
|
| Gastroenteritis |
|
| Diarrhoea |
|
| Enteritis |
|
| Dyspepsia |
|
| Nausea |
|
| Vomiting |
|
| Headache |
|
| Dizziness |
|
| Dermatitis atopic |
|
| Furuncle (excluding genital) |
|
| Itching |
|
| Rash |
|
| Rash impetiginous |
|
| Sweating increased |
|
| Allergic conjunctivitis |
|
| Conjunctivitis |
|
| ALT increased |
|
| AST increased |
|
| Hand foot and mouth disease |
|
| Title | Measurements |
|---|---|
|
| Grade 3 Injection-site Erythema |
|
| Any Injection-site Swelling |
|
| Grade 3 Injection-site Swelling |
|
| Any Fever |
|
| Grade 3 Fever |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Any Malaise |
|
| Grade 3 Malaise |
|
| Any Myalgia |
|
| Grade 3 Myalgia |
|