NCT01437423

Regulatory Post-Marketing Surveillance Study for TETRAXIM™

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Months – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Poliomyelitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-09-20
• Last updated: 2022-03-28
• Results posted: 2017-01-04

Locations

1 site across 1 country: South Korea