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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01929291
First Posted: August 27, 2013
Last Update Posted: August 5, 2016
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.
Information provided by (Responsible Party):
GlaxoSmithKline
August 22, 2013
August 27, 2013
August 5, 2016
September 2013
January 2016   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01929291 on ClinicalTrials.gov Archive Site
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Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea
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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Pre-adolescents, adolescents adults and elderly who receive Boostrix as a part of routine practice at a private clinic or hospital.
  • Tetanus
  • Acellular Pertussis
  • Diphtheria
  • 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
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.
Interventions:
  • Biological: Boostrix
  • Other: Safety data collection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
690
January 2016
January 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01929291
115374
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GlaxoSmithKline
GlaxoSmithKline
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Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2016