The purpose of this study is to collect safety information following routine vaccination with Synflorix™ 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.
Study Type
OBSERVATIONAL
Enrollment
622
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.
GSK Investigational Site
Suwon, Kyonggi-do, South Korea
Occurrence of unexpected adverse events
Time frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Occurrence of expected adverse events
Time frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Occurrence of serious adverse events
Time frame: From the first dose in the study up to 30 days (Day 0 - Day 29) after the last dose.
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