Post Marketing Surveillance for ADACEL™ in South 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

Clinical Phase

PHASE4

Total Enrollment

659 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-09-30

Brief Summary

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This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".

The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.

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Detailed Description

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Conditions

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Diphtheria Tetanus Pertussis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study Group

Group Type EXPERIMENTAL

ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined

Intervention Type BIOLOGICAL

0.5 mL, intramuscular (IM)

Interventions

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ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined

0.5 mL, intramuscular (IM)

Intervention Type BIOLOGICAL

Other Intervention Names

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Adacel™

Eligibility Criteria

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Inclusion Criteria

* Subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis.
* Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject.