Post Marketing Surveillance for ADACEL™ in South Korea

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01137435
First received: June 3, 2010
Last updated: July 23, 2014
Last verified: July 2014

June 3, 2010
July 23, 2014
June 2010
March 2016   (final data collection date for primary outcome measure)
Information concerning reported adverse events following ADACEL™ vaccination. [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01137435 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post Marketing Surveillance for ADACEL™ in South Korea
Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Pertussis
Biological: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
0.5 mL, intramuscular (IM)
Other Name: Adacel™
Experimental: Study Group
Intervention: Biological: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
November 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
11 Years to 64 Years
Yes
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com
Korea, Republic of
 
NCT01137435
Td533, UTN: U1111-1112-8558
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP