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Post Marketing Surveillance for ADACEL™ in South Korea

Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diphtheria; Tetanus; Pertussis

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

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.

Overall contact:
Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com

Summary

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.

Clinical Details

Official title: Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Information concerning reported adverse events following ADACEL™ vaccination.

Eligibility

Minimum age: 11 Years. Maximum age: 64 Years. Gender(s): Both.

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 and Contacts

Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com

Jung-gu, Incheon, Korea, Republic of; Recruiting
Additional Information

Starting date: June 2010
Last updated: June 3, 2010

Page last updated: October 04, 2010

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