Regulatory Post-Marketing Surveillance Study for TETRAXIM™
2 other identifiers
interventional
600
1 country
1
Brief Summary
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No. 2009-46 "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
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 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 19, 2011
CompletedFirst Posted
Study publicly available on registry
September 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
January 4, 2017
CompletedMarch 28, 2022
March 1, 2022
4.4 years
September 19, 2011
November 6, 2016
March 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
The number of participants reporting unexpected adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis)) during 6 year surveillance period.
Up to 30 days post-primary and booster vaccination
Other Outcomes (3)
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Up to 30 days post-primary and booster vaccination
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Up to 30 days post-primary and booster of TETRAXIM™ vaccination
Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
Up to 30 days post-primary and booster of vaccination
Study Arms (1)
TETRAXIM™ vaccine
EXPERIMENTALParticipants will receive a primary or booster dose of TETRAXIM™
Interventions
0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination
Eligibility Criteria
You may qualify if:
- Subjects who are 2 months or more of age (as indicated in the currently approved local product labeling) and who are given the study vaccine at least one dose or more, during a routine health-care visit, as primary immunization or booster immunization for the prevention of diphtheria, tetanus, pertussis, poliomyelitis.
- Written informed consent obtained from the subject's parents/legal representative.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Seoul, South Korea
Related Publications (1)
Choe YJ, Vidor E, Manson C. Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea, 2009 to 2015. Infect Dis Ther. 2022 Aug;11(4):1479-1492. doi: 10.1007/s40121-022-00650-8. Epub 2022 May 14.
PMID: 35575974DERIVED
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 SA
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
September 19, 2011
First Posted
September 20, 2011
Study Start
June 1, 2011
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
March 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