Regulatory Post-Marketing Surveillance Study for TETRAXIM™

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Diphtheria Tetanus Pertussis Poliomyelitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TETRAXIM™ vaccine

Participants will receive a primary or booster dose of TETRAXIM™

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination

Interventions

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

0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination

Intervention Type BIOLOGICAL

Other Intervention Names

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TETRAXIM™

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes