Post Marketing Surveillance for ADACEL™ in South Korea

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

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

November 2016