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

NCT01929291 | Completed Results

• 1 other identifier: 115374
• Study Type: observational
• Target: 682
• Locations: 1 country
• Sites: 1

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.

Conditions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Keywords

Korea; Post-marketing surveillance; Boostrix; Prescribing information; Safety

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

Boostrix Group

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; Other: Safety data collection

Interventions

Boostrix BIOLOGICAL

Single intramuscular injection

Also known as: dTPa vaccine

Boostrix Group

Safety data collection OTHER

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

Boostrix Group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pre-adolescents, adolescents adults and elderly who receive Boostrix as a part of routine practice at a private clinic or hospital.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Suwon, 443-380, South Korea

Location

Related Publications (1)

• Park HJ, Kim SJ, Song R, Chen J, Kim JH, Devadiga R, Kang HC. A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea. J Korean Med Sci. 2019 Mar 22;34(12):e105. doi: 10.3346/jkms.2019.34.e105. eCollection 2019 Apr 1.

  PMID: 30940999 BACKGROUND

MeSH Terms

Interventions

Boostrix

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 27, 2013
• Study Start: September 23, 2013
• Primary Completion: January 11, 2016
• Study Completion: January 11, 2016
• Last Updated: September 25, 2019
• Results First Posted: March 29, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)