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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 11, 2016

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

Interventions

  • Biological: Boostrix
    • Single intramuscular injection
  • 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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

References

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.

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