Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea
|ClinicalTrials.gov Identifier: NCT01929291|
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : March 29, 2019
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment|
|Diphtheria-Tetanus-acellular Pertussis Vaccines||Biological: Boostrix Other: Safety data collection|
|Study Type :||Observational|
|Actual Enrollment :||682 participants|
|Official Title:||Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Reduced Antigen Content Diphtheria-tetanus Toxoids and Acellular Pertussis Vaccine (dTPa), Boostrix When Administered According to the Approved Prescribing Information in Korea|
|Actual Study Start Date :||September 23, 2013|
|Actual Primary Completion Date :||January 11, 2016|
|Actual Study Completion Date :||January 11, 2016|
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.
Single intramuscular injection
Other Name: dTPa vaccine
Other: Safety data collection
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
- Number of Unexpected Adverse Events (AEs) [ Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination. ]Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.
- Number of Expected AEs. [ Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination. ]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.
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929291
|Korea, Republic of|
|GSK Investigational Site|
|Suwon-si, Korea, Republic of, 443-380|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|