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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

682 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-23

Study Completion Date

2016-01-11

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Diphtheria-Tetanus-acellular Pertussis Vaccines

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Boostrix Group

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.

Boostrix

Intervention Type BIOLOGICAL

Single intramuscular injection

Safety data collection

Intervention Type OTHER

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

Interventions

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Boostrix

Single intramuscular injection

Intervention Type BIOLOGICAL

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

Intervention Type OTHER

Other Intervention Names

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dTPa vaccine

Eligibility Criteria

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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.