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

N/ACompletedNCT01929291

GlaxoSmithKline682 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

682

Conditions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Interventions

BoostrixBIOLOGICAL

Single intramuscular injection

Safety data collectionOTHER

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

Sex: ALLMin age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Suwon, South Korea

Outcomes

Primary Outcomes

Number of Unexpected Adverse Events (AEs)

Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.

Time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.

Number of Expected AEs.

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.

Time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.

Number of Subjects With Serious Adverse Events (SAEs)

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.

Time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.

Data from ClinicalTrials.gov

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