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Post Marketing Surveillance for ADACEL™ in South Korea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01137435
First received: June 3, 2010
Last updated: November 6, 2016
Last verified: November 2016
June 3, 2010
November 6, 2016
June 2010
March 2016   (Final data collection date for primary outcome measure)
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ [ Time Frame: 30 days post-vaccination ]
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Information concerning reported adverse events following ADACEL™ vaccination. [ Time Frame: 30 days post-vaccination ]
Complete list of historical versions of study NCT01137435 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ [ Time Frame: 30 days post-vaccination ]
    Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
  • Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ [ Time Frame: 30 days post-vaccination ]
    All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
  • Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ [ Time Frame: 7 days post-vaccination ]

    Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.

    All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period.

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
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.
 
Completed
659
September 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 :

Sexes Eligible for Study: All
11 Years to 64 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01137435
Td533
UTN: U1111-1112-8558 ( Other Identifier: WHO )
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi.
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
November 2016

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