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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929291
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : March 29, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment
Diphtheria-Tetanus-acellular Pertussis Vaccines Biological: Boostrix Other: Safety data collection

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

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Study Type : Observational
Actual Enrollment : 682 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 23, 2013
Actual Primary Completion Date : January 11, 2016
Actual Study Completion Date : January 11, 2016


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.
Biological: Boostrix
Single intramuscular injection
Other Name: dTPa vaccine

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929291


Locations
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Korea, Republic of
GSK Investigational Site
Suwon-si, Korea, Republic of, 443-380
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01929291    
Other Study ID Numbers: 115374
First Posted: August 27, 2013    Key Record Dates
Results First Posted: March 29, 2019
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GlaxoSmithKline:
Korea
Post-marketing surveillance
Boostrix
Prescribing information
Safety
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs