Post Marketing Surveillance for ADACEL™ in South Korea

Phase 4

Completed

• Conditions: Diphtheria; Tetanus; Pertussis

• Registration Number: NCT01137435
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".

The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Results First Submitted: 2016-11-06
• Results First Submitted QC: 2016-11-06
• Results First Posted: 2017-01-04
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 659

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™	30 days post-vaccination	All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.