- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929291
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
Status
Completed
Intervention / Treatment
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
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Suwon-si, Korea, Republic of, 443-380
- GSK Investigational Site
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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.
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Single intramuscular injection
Other Names:
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
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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.
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Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.
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During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
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Number of Expected AEs.
Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
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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.
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During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
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Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
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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.
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During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
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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
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Bordetella Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Clostridium Infections
- Corynebacterium Infections
- Whooping Cough
- Tetanus
- Diphtheria
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 115374
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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