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)
2 other identifiers
interventional
659
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2010
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 3, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
January 4, 2017
CompletedApril 28, 2022
March 1, 2022
5.8 years
June 3, 2010
November 6, 2016
March 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days post-vaccination
Other Outcomes (3)
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
30 days post-vaccination
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
30 days post-vaccination
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
7 days post-vaccination
Study Arms (1)
Study Group
EXPERIMENTALInterventions
0.5 mL, intramuscular (IM)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Jung-gu, Incheon, South Korea
Unknown Facility
Seoul, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2010
First Posted
June 4, 2010
Study Start
June 1, 2010
Primary Completion
March 1, 2016
Study Completion
September 1, 2016
Last Updated
April 28, 2022
Results First Posted
January 4, 2017
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
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