Regulatory Post-Marketing Surveillance Study for TETRAXIM™

Sanofi

Status and phase: Completed; Phase 4

Conditions: Poliomyelitis; Diphtheria; Pertussis; Tetanus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437423

E2I59

U1111-1114-7745 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 600 patients

Sex: All

Ages: 2 months to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

TETRAXIM™ vaccine

Experimental group

Description:

Participants will receive a primary or booster dose of TETRAXIM™

Treatment:

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