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Post Marketing Surveillance for ADACEL™ in South Korea

This study is currently recruiting participants.
Verified February 2013 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01137435
First received: June 3, 2010
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
 Biological: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Information concerning reported adverse events following ADACEL™ vaccination. [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: June 2010
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group Biological: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
0.5 mL, intramuscular (IM)
Other Name: Adacel™

  Eligibility

Ages Eligible for Study:   11 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis.
  • Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject.

Exclusion Criteria :

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137435

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

Locations
Korea, Republic of
Recruiting
Jung-gu, Incheon, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01137435     History of Changes
Other Study ID Numbers: Td533, UTN: U1111-1112-8558
Study First Received: June 3, 2010
Last Updated: February 5, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Sanofi:
Adacel
Diphtheria
Tetanus
Pertussis

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
 Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013