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Post Marketing Surveillance for ADACEL™ in South Korea

NCT01137435 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 659

Last updated 2022-04-28

Study results available
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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.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis

Interventions

BIOLOGICAL

ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined

0.5 mL, intramuscular (IM)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137435 on ClinicalTrials.gov