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Regulatory Post-Marketing Surveillance Study for TETRAXIM™

CompletedPhase 4

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Diphtheria, Tetanus, Pertussis, Poliomyelitis

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

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 2 Months to 6 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (1)

Seoul, South Korea