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Post Marketing Surveillance for ADACEL™ in South Korea

CompletedPhase 4

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Diphtheria, Tetanus, Pertussis

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

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 11 Years to 64 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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)

Jung-gu, Incheon, South Korea
Seoul, South Korea