Post Marketing Surveillance for ADACEL™ in South Korea

Sanofi Pasteur, a Sanofi Company659 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

659

Conditions

Diphtheria Tetanus Pertussis

Interventions

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

0.5 mL, intramuscular (IM)

Eligibility

Sex: ALLMin age: 11 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. Exclusion Criteria : * None

Locations (2)

Unnamed facility

Jung-gu, Incheon, South Korea

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™

All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.

Time frame: 30 days post-vaccination

Data from ClinicalTrials.gov

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