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The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
Protocol amendment 3 rationale was as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boostrix Group | Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boostrix | Biological | Single intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Unexpected Adverse Events (AEs) | Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea. | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. |
| Number of Expected AEs. | Expected AEs were defined as an adverse event that was expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information in Korea. | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | An SAE was defined as any AE that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or that was a congenital anomaly/birth defect in the offspring of a study subject. | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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Pre-adolescents, adolescents adults and elderly who receive Boostrix as a part of routine practice at a private clinic or hospital.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Suwon | 443-380 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30940999 | Background | Park HJ, Kim SJ, Song R, Chen J, Kim JH, Devadiga R, Kang HC. A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea. J Korean Med Sci. 2019 Mar 22;34(12):e105. doi: 10.3346/jkms.2019.34.e105. eCollection 2019 Apr 1. |
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A total of 682 subjects case report forms were retrieved during the post-marketing surveillance period. Among those, 672 subjects were assessed for safety and the safety data from 10 subjects who did not fulfilled inclusion/exclusion criteria were analyzed separately.
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| ID | Title | Description |
|---|---|---|
| FG000 | Boostrix Group | Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Boostrix Group | Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Unexpected Adverse Events (AEs) | Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea. | The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the study vaccine. | Posted | Number | Events | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. |
|
|
AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period 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 | Boostrix Group | Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pruritus | General disorders | WHO-ART 092 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| C505143 | Boostrix |
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| Safety data collection | Other | Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form |
|
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Expected AEs. | Expected AEs were defined as an adverse event that was expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information in Korea. | The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the study vaccine. | Posted | Number | Events | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. |
|
|
|
| Primary | Number of Subjects With Serious Adverse Events (SAEs) | An SAE was defined as any AE that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or that was a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the study vaccine. | Posted | Count of Participants | Participants | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. |
|
|
|
| 0 |
| 672 |
| 6 |
| 672 |
| 90 |
| 672 |
| Genital infection | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Birth premature | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Fever | General disorders | WHO-ART 092 | Systematic Assessment |
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| Injection site rash | General disorders | WHO-ART 092 | Systematic Assessment |
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| Injection site anaesthesia | General disorders | WHO-ART 092 | Systematic Assessment |
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| Injection site warmth | General disorders | WHO-ART 092 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| Gastroesophageal reflux | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| Irritable bowel syndrome | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| Common cold | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Systematic Assessment |
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| Sputum disorder | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Systematic Assessment |
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| Labour premature | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Leukorrhoea | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Birth premature | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Genital infection | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Pre-eclampsia | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Pruritus genital | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Vaginitis | Reproductive system and breast disorders | WHO-ART 092 | Systematic Assessment |
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| Chills | General disorders | WHO-ART 092 | Systematic Assessment |
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| Skeletal pain | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Systematic Assessment |
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| Pyuria | Renal and urinary disorders | WHO-ART 092 | Systematic Assessment |
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| Bacteriuria | Renal and urinary disorders | WHO-ART 092 | Systematic Assessment |
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| Cardiomegaly | Vascular disorders | WHO-ART 092 | Systematic Assessment |
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| Pressure blood increased | Vascular disorders | WHO-ART 092 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | WHO-ART 092 | Systematic Assessment |
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| Foetal movements decreased | Pregnancy, puerperium and perinatal conditions | WHO-ART 092 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | WHO-ART 092 | Systematic Assessment |
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| Palpitation | Cardiac disorders | WHO-ART 092 | Systematic Assessment |
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| Injection site Pain | General disorders | WHO-ART 092 | Systematic Assessment |
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| Injection site Swelling | General disorders | WHO-ART 092 | Systematic Assessment |
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| Injection site Mass | General disorders | WHO-ART 092 | Systematic Assessment |
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| Injection site Erythema | General disorders | WHO-ART 092 | Systematic Assessment |
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| Injection site Tenderness | General disorders | WHO-ART 092 | Systematic Assessment |
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| Injection site Reaction | General disorders | WHO-ART 092 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | WHO-ART 092 | Systematic Assessment |
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| Coughing | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Systematic Assessment |
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| Fever | General disorders | WHO-ART 092 | Systematic Assessment |
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| Fatigue | General disorders | WHO-ART 092 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | WHO-ART 092 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | WHO-ART 092 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | WHO-ART 092 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | WHO-ART 092 | Systematic Assessment |
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| Headache | Nervous system disorders | WHO-ART 092 | Systematic Assessment |
|
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