Regulatory Post-Marketing Surveillance Study for TETRAXIM™

Tetanus Clinical Trial

Official title:

Regulatory Post-Marketing Surveillance (PMS) Study for TETRAXIM™(Combined Vaccine of Adsorbed Diphtheria, Tetanus, Acellular Pertussis and Enhanced Inactivated Poliomyelitis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437423
• Other study ID #: E2I59
• Secondary ID: U1111-1114-7745
• Status: Completed
• Phase: Phase 4
• Start date: June 2011
• Est. completion date: November 2015

Study information

• Verified date: March 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary vaccination will be administered from 2 months and booster vaccination from age 4 to 6 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.	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.	Up to 30 days post-primary and booster vaccination
Other	Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.	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	Up to 30 days post-primary and booster of TETRAXIM™ vaccination
Other	Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.	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.	Up to 30 days post-primary and booster of vaccination
Primary	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

External Links

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