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

September 11, 2019 updated by: GlaxoSmithKline

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

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

682

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Single intramuscular injection
Other Names:
  • dTPa vaccine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
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.
During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
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.
During the 30-day (Day 0 - Day 29) follow-up period after vaccination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2013

Primary Completion (Actual)

January 11, 2016

Study Completion (Actual)

January 11, 2016

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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