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

Diphtheria-Tetanus-acellular Pertussis Vaccines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929291
• Other study ID #: 115374
• Status: Completed
• Start date: September 23, 2013
• Est. completion date: January 11, 2016

Study information

• Verified date: September 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 682
• Est. completion date: January 11, 2016
• Est. primary completion date: January 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diphtheria
• Diphtheria-Tetanus-acellular Pertussis Vaccines
• Tetanus
• Whooping Cough

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Suwon-si

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.