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The purpose of this study is to collect safety information following routine vaccination with Synflorixâ„¢ among infants in Korea.
Rationale for the protocol amendment: The therapeutic indication for Synflorix in Korea has been updated. The protocol is being amended to reflect this update.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synflorix Group | Infants and children who received at least one dose of Synflorixâ„¢ as a part of routine practice at a private clinic or hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synflorixâ„¢ Data collection | Other | Safety monitoring: recording of adverse events during 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 unexpected adverse events | During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose. | |
| Occurrence of expected adverse events | During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose. | |
| Occurrence of serious adverse events | From the first dose in the study up to 30 days (Day 0 - Day 29) after the last dose. |
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Inclusion Criteria:
Exclusion Criteria:
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Infants and children who receive at least one dose of Synflorix 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, Kyonggi-do | 443-721 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30084702 | Derived | Lee SM, Lee JH, Song ES, Kim SJ, Kim JH, Jakes RW, Devadiga R, Park MS. A 6-year safety surveillance of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in South Korea. Hum Vaccin Immunother. 2018;14(12):3019-3025. doi: 10.1080/21645515.2018.1502525. Epub 2018 Aug 29. |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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