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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-7745 | Other Identifier | WHO |
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The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No. 2009-46 "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
Primary vaccination will be administered from 2 months and booster vaccination from age 4 to 6 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TETRAXIM™ vaccine | Experimental | Participants will receive a primary or booster dose of TETRAXIM™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio | Biological | 0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | The number of participants reporting unexpected adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis)) during 6 year surveillance period. | Up to 30 days post-primary and booster vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature) and Crying abnormal. Grade 3 Injection-site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, >39.5˚C; Crying abnormal, >3 hours. |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35575974 | Derived | Choe YJ, Vidor E, Manson C. Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea, 2009 to 2015. Infect Dis Ther. 2022 Aug;11(4):1479-1492. doi: 10.1007/s40121-022-00650-8. Epub 2022 May 14. |
| 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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Of the 662 participants whose case report forms were retrieved, 647 participants were included in the safety analysis.
Study participants were enrolled for a 6 year surveillance period (31 August 2009 to 30 August 2015) at 8 clinic centers in Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | TETRAXIM™ Vaccination and Booster Group | Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TETRAXIM™ Vaccination and Booster Group | Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved. |
| 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 | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | The number of participants reporting unexpected adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis)) during 6 year surveillance period. | Adverse events were reported from the Safety Analysis Set. | Posted | Number | Participants | Up to 30 days post-primary and booster vaccination |
|
Adverse event data (solicited and unsolicited) were collected up to 30 days after the primary series injection of TETRAXIM™ during the 6 year 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 | TETRAXIM™ Vaccination and Booster Group | Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-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 |
| D011051 | Poliomyelitis |
| 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 |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Up to 30 days post-primary and booster vaccination |
| Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | The number of participants reporting unsolicited adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 year surveillance period | Up to 30 days post-primary and booster of TETRAXIM™ vaccination |
| Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. | The number of participants reporting adverse events by demographic characteristic following a primary series injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 years surveillance period is reported. | Up to 30 days post-primary and booster of vaccination |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
|
|
| Other Pre-specified | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature) and Crying abnormal. Grade 3 Injection-site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, >39.5˚C; Crying abnormal, >3 hours. | Solicited adverse events were reported from the Safety Analysis Set. | Posted | Number | Participants | Up to 30 days post-primary and booster vaccination |
|
|
|
| Other Pre-specified | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | The number of participants reporting unsolicited adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 year surveillance period | Unsolicited adverse events were reported from the Safety Analysis Set. | Posted | Number | Participants | Up to 30 days post-primary and booster of TETRAXIM™ vaccination |
|
|
|
| Other Pre-specified | Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. | The number of participants reporting adverse events by demographic characteristic following a primary series injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 years surveillance period is reported. | Adverse events were reported from the Safety Analysis Set. | Posted | Number | Participants | Up to 30 days post-primary and booster of vaccination |
|
|
|
| 0 |
| 647 |
| 79 |
| 647 |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-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 |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| Title | Measurements |
|---|---|
|
| Grade 3 Injection-site Erythema |
|
| Any Injection-site Swelling |
|
| Grade 3 Injection-site Swelling |
|
| Any Fever |
|
| Grade 3 Fever |
|
| Any Crying abnormal |
|
| Grade 3 Crying abnormal |
|
| Title | Measurements |
|---|---|
|
| Bronchiolitis |
|
| Coughing |
|
| Rhinitis |
|
| Common cold |
|
| Tonsillitis |
|
| Allergic rhinitis |
|
| Asthma |
|
| Croup |
|
| Nasopharyngitis |
|
| Enteritis |
|
| Gastroenteritis |
|
| Diarrhoea |
|
| Constipation |
|
| Gastritis acute |
|
| Vomiting |
|
| Dermatitis contact |
|
| Dermatitis atopic |
|
| Dermatitis diaper |
|
| Rash impetiginous |
|
| Contact eczema |
|
| Dermatitis seborrhoeic |
|
| Eczema allergic |
|
| Fever |
|
| Otitis media |
|
| Hand foot and mouth disease |
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| Conjunctivitis |
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| Red eye |
|
| Irritability |
|
| Title | Measurements |
|---|---|
|
| Age; 48 to <60 months (N=35) |
|
| Age; 60 to <72 months (N=7) |
|
| Age; ≥72 months (N=3) |
|