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The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infanrix-IPV group | Infants and children who received at least one dose of Infanrix-IPV as a part of routine practice at a private clinic or hospital in korea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infanrix-IPV 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose. | |
| Occurrence of serious adverse events | Starting at Visit 1 in the post-marketing surveillance (PMS) up to 30 days (Day 0 to Day 29) after the last dose is administered in the PMS |
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Inclusion Criteria:
Exclusion Criteria:
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Infants and children who receive at least one dose of Infanrix-IPV 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 | Seoul | 130-702 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30668217 | Background | Lee SM, Kim SJ, Chen J, Song R, Kim JH, Devadiga R, Kim YK. Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children. Hum Vaccin Immunother. 2019;15(5):1145-1153. doi: 10.1080/21645515.2019.1572406. Epub 2019 Mar 19. |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| 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 |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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