Post Marketing Surveillance for ADACEL™ in South Korea

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diphtheria; Pertussis; Tetanus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01137435

Td533

UTN: U1111-1112-8558 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 659 patients

Sex: All

Ages: 11 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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659 participants in 1 patient group

Study Group

Experimental group

Treatment:

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