Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea

Completed

• Conditions: Diphtheria-Tetanus-acellular Pertussis Vaccines
• Interventions: Biological: Boostrix; Other: Safety data collection

• Registration Number: NCT01929291
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.

Detailed Description

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 Timeline

• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-27
• Study Start: 2013-09-23
• Primary Completion: 2016-01-11
• Study Completion: 2016-01-11
• Results First Submitted: 2018-12-17
• Results First Submitted QC: 2018-12-17
• Results First Posted: 2019-03-29
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 682

Inclusion Criteria

• Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.

Exclusion Criteria

• Those who are not eligible for vaccination according to the local Prescribing Information.
• Child in care.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Boostrix Group	Boostrix	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.
Boostrix Group	Safety data collection	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.

Primary Outcome Measures

Name	Time	Method
Number of Expected AEs.	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 Unexpected Adverse Events (AEs)	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 Subjects With Serious Adverse Events (SAEs)	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Suwon-si, Korea, Republic of