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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
  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: 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:
  • 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.


Other Outcome Measures:
  • 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.



Enrollment: 659
Study Start Date: June 2010
Study Completion Date: September 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™

  Eligibility

Ages Eligible for Study:   11 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 :

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137435

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

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01137435     History of Changes
Other Study ID Numbers: Td533  UTN: U1111-1112-8558 
Study First Received: June 3, 2010
Results First Received: November 6, 2016
Last Updated: November 6, 2016
Individual Participant Data  
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.

Keywords provided by Sanofi:
Adacel
Diphtheria
Tetanus
Pertussis

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

ClinicalTrials.gov processed this record on February 17, 2017