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

NCT01929291 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 682

Last updated 2019-09-25

Study results available
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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.

Conditions

  • Diphtheria-Tetanus-acellular Pertussis Vaccines

Interventions

BIOLOGICAL

Boostrix

Single intramuscular injection

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-23
Primary Completion
2016-01-11
Completion
2016-01-11

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929291 on ClinicalTrials.gov