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Post Marketing Surveillance for ADACEL™ in South Korea

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company ) Identifier:
First received: June 3, 2010
Last updated: March 24, 2016
Last verified: March 2016

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

Study Type: Interventional
Study Design: 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:

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 ]

Enrollment: 659
Study Start Date: June 2010
Estimated Study Completion Date: November 2016
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™


Ages Eligible for Study:   11 Years to 64 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 :

  Contacts and Locations
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Please refer to this study by its identifier: NCT01137435

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

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT01137435     History of Changes
Other Study ID Numbers: Td533  UTN: U1111-1112-8558 
Study First Received: June 3, 2010
Last Updated: March 24, 2016
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections processed this record on October 25, 2016