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: ADACELâ¢: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
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