Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01929291|
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : August 5, 2016
|Condition or disease||Intervention/treatment|
|Tetanus Acellular Pertussis Diphtheria||Biological: Boostrix Other: Safety data collection|
Protocol amendment 3 rationale was as follows:
- Age for analysis set is specified.
- Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination.
- Pregnancy notifications must be done within 2 weeks
|Study Type :||Observational|
|Actual Enrollment :||690 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|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
U.S. FDA Resources
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 vaccineOther: 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
- Occurrence of adverse events [ Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination ]
- Occurrence of serious adverse events [ Time Frame: Starting at Visit 1 in the post-marketing surveillance up to 30 days (Day 0 to Day 29) after the vaccine is administered ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|