Regulatory Post-Marketing Surveillance Study for TETRAXIM™

Brief Title

Regulatory Post-Marketing Surveillance Study for TETRAXIM™

Official Title

Regulatory Post-Marketing Surveillance (PMS) Study for TETRAXIM™(Combined Vaccine of Adsorbed Diphtheria, Tetanus, Acellular Pertussis and Enhanced Inactivated Poliomyelitis)

Brief Summary

      The purpose of this study is to assess the safety of TETRAXIM™ administered in routine
      clinical practice according to Korea Food and Drug Administration Notification No. 2009-46
      "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.

Detailed Description

      Primary vaccination will be administered from 2 months and booster vaccination from age 4 to
      6 years.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.

Condition

Diphtheria

Intervention

TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio

Study Arms / Comparison Groups

 TETRAXIM™ vaccine

Description:  Participants will receive a primary or booster dose of TETRAXIM™

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 2011

Completion Date

November 2015

Primary Completion Date

November 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects who are 2 months or more of age (as indicated in the currently approved local
             product labeling) and who are given the study vaccine at least one dose or more,
             during a routine health-care visit, as primary immunization or booster immunization
             for the prevention of diphtheria, tetanus, pertussis, poliomyelitis.

          -  Written informed consent obtained from the subject's parents/legal representative.

Gender

All

Ages

2 Months - 6 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, ,

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations

NCT ID

NCT01437423

Organization ID

E2I59

Secondary IDs

U1111-1114-7745

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company

Study Sponsor

Medical Director, Study Director, Sanofi Pasteur SA

Verification Date

November 2016