Post Market Surveillance for Infanrix™

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-01

Study Completion Date

2008-06-23

Brief Summary

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The purpose of this study was to investigate the following questions through post-marketing surveillance:

* Unknown/Unexpected adverse events and the serious adverse events.
* The circumstances in which the adverse events occurred under the practical application.
* Factors considered to have influence on safety.
* Factors considered to have influence on efficacy.
* Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.

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Detailed Description

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Conditions

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Diphtheria Acellular Pertussis Tetanus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Infanrix Group

Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).

GSK Biologicals' Infanrix™

Intervention Type BIOLOGICAL

Primary and booster vaccination according to vaccination schedule. Intramuscular injection

Interventions

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GSK Biologicals' Infanrix™

Primary and booster vaccination according to vaccination schedule. Intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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DTPa

Eligibility Criteria

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Inclusion Criteria

All children receiving Infanrix™ were eligible for this survey.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Daegu, , South Korea

Site Status

Countries

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South Korea

Study Documents

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