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

Study Overview
=================
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

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

Conditions
-----------------
Diphtheria-Tetanus-acellular Pertussis Vaccines

Intervention / Treatment
-----------------
* Biological: Boostrix
* Other: Safety data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Boostrix Group<br>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. | Biological: Boostrix<br>* Single intramuscular injection<br>* Other names: dTPa vaccine;Other: Safety data collection<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Unexpected Adverse Events (AEs) | Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea. | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. | 
| Number of Expected AEs. | 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. | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. | 
| Number of Subjects With Serious Adverse Events (SAEs) | 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. | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Korea, Post-marketing surveillance, Boostrix, Prescribing information, Safety