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

Tracking Information

First Received Date ^ICMJE

June 3, 2010

Last Updated Date

February 5, 2013

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01137435 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Post Marketing Surveillance for ADACEL™ in South Korea

Official Title ^ICMJE

Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Diphtheria
Tetanus
Pertussis

Intervention ^ICMJE

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

0.5 mL, intramuscular (IM)

Other Name: Adacel™

Study Arm (s)

Experimental: Study Group

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

November 2016

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

11 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Public Registry Sanofi Pasteur

RegistryContactUs@sanofipasteur.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01137435

Other Study ID Numbers ^ICMJE

Td533, UTN: U1111-1112-8558

Has Data Monitoring Committee

Responsible Party

Sanofi

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Sanofi Pasteur Inc.

Information Provided By

Sanofi

Verification Date

February 2013

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

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