search
Back to results

Post Marketing Surveillance for ADACEL™ in South Korea

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Adacel, Diphtheria, Tetanus, Pertussis

Eligibility Criteria

11 Years - 64 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Outcomes

Primary Outcome Measures

Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2010
Last Updated
March 30, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
search

1. Study Identification

Unique Protocol Identification Number
NCT01137435
Brief Title
Post Marketing Surveillance for ADACEL™ in South Korea
Official Title
Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis
Keywords
Adacel, Diphtheria, Tetanus, Pertussis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
659 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
Other Intervention Name(s)
Adacel™
Intervention Description
0.5 mL, intramuscular (IM)
Primary Outcome Measure Information:
Title
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
Description
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Time Frame
30 days post-vaccination
Other Pre-specified Outcome Measures:
Title
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Description
Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Time Frame
30 days post-vaccination
Title
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Description
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Time Frame
30 days post-vaccination
Title
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Description
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.
Time Frame
7 days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 : None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Jung-gu
State/Province
Incheon
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

Post Marketing Surveillance for ADACEL™ in South Korea

We'll reach out to this number within 24 hrs