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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 22, 2013
Last updated: August 4, 2016
Last verified: August 2016
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 Intervention
Tetanus Acellular Pertussis Diphtheria Biological: Boostrix Other: Safety data collection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination ]
  • Occurrence of serious adverse events [ Time Frame: Starting at Visit 1 in the post-marketing surveillance up to 30 days (Day 0 to Day 29) after the vaccine is administered ]

Enrollment: 690
Study Start Date: September 2013
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
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

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

Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01929291

Korea, Republic of
GSK Investigational Site
Suwon-si, Korea, Republic of, 443-380
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01929291     History of Changes
Other Study ID Numbers: 115374
Study First Received: August 22, 2013
Last Updated: August 4, 2016

Keywords provided by GlaxoSmithKline:
Post-marketing surveillance
Prescribing information

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on September 19, 2017