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Regulatory Post-Marketing Surveillance Study for TETRAXIM™

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
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 Diphtheria, Tetanus, Pertussis, Poliomyelitis, TETRAXIM™

Eligibility Criteria

2 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TETRAXIM™ vaccine

Arm Description

Participants will receive a primary or booster dose of TETRAXIM™

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2011
Last Updated
March 15, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01437423
Brief Title
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
Official Title
Regulatory Post-Marketing Surveillance (PMS) Study for TETRAXIM™(Combined Vaccine of Adsorbed Diphtheria, Tetanus, Acellular Pertussis and Enhanced Inactivated Poliomyelitis)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (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
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.
Detailed Description
Primary vaccination will be administered from 2 months and booster vaccination from age 4 to 6 years.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
TETRAXIM™ vaccine
Arm Type
Experimental
Arm Description
Participants will receive a primary or booster dose of TETRAXIM™
Intervention Type
Biological
Intervention Name(s)
TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
Other Intervention Name(s)
TETRAXIM™
Intervention Description
0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination
Primary Outcome Measure Information:
Title
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Description
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.
Time Frame
Up to 30 days post-primary and booster vaccination
Other Pre-specified Outcome Measures:
Title
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Description
Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature) and Crying abnormal. Grade 3 Injection-site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, >39.5˚C; Crying abnormal, >3 hours.
Time Frame
Up to 30 days post-primary and booster vaccination
Title
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Description
The number of participants reporting unsolicited 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 the 6 year surveillance period
Time Frame
Up to 30 days post-primary and booster of TETRAXIM™ vaccination
Title
Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
Description
The number of participants reporting adverse events by demographic characteristic following a primary series injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 years surveillance period is reported.
Time Frame
Up to 30 days post-primary and booster of vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur SA
Official's Role
Study Director
Facility Information:
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
Citations:
PubMed Identifier
35575974
Citation
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.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
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Regulatory Post-Marketing Surveillance Study for TETRAXIM™

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