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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01929291
First received: August 22, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Pre-adolescents (aged (≥11 years to <12 years), adolescents (aged ≥12 to <19 years) and adults (aged ≥19 years) 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

  Eligibility

Ages Eligible for Study:   11 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pre-adolescents, adolescents and adults 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.
  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 ClinicalTrials.gov identifier: NCT01929291

Contacts
Contact: US GSK Clinical Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Korea, Republic of
GSK Investigational Site Recruiting
Suwon-si, Korea, Republic of, 443-380
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01929291     History of Changes
Other Study ID Numbers: 115374
Study First Received: August 22, 2013
Last Updated: July 3, 2014
Health Authority: Korea: Korea Food & Drug Administration

Keywords provided by GlaxoSmithKline:
Korea
Post-marketing surveillance
Boostrix
Prescribing information
Safety

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014