Brief Title
Post Marketing Surveillance for ADACEL™ in South Korea
Official Title
Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)
Brief 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
Condition
Diphtheria
Intervention
ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
Study Arms / Comparison Groups
Study Group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
659
Start Date
June 2010
Completion Date
September 2016
Primary Completion Date
March 2016
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
Gender
All
Ages
11 Years - 64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01137435
Organization ID
Td533
Secondary IDs
UTN: U1111-1112-8558
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
March 2022