Regulatory Post-Marketing Surveillance Study for TETRAXIM™

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Sanofi
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company ) Identifier:
First received: September 19, 2011
Last updated: September 4, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Biological: TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Regulatory Post-Marketing Surveillance (PMS) Study for TETRAXIM™(Combined Vaccine of Adsorbed Diphtheria, Tetanus, Acellular Pertussis and Enhanced Inactivated Poliomyelitis)

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • A description of vaccine safety profile in terms of solicited injection site and systemic reactions and unsolicited adverse events, including serious adverse events. [ Time Frame: 30 Days post-vaccination ] [ Designated as safety issue: No ]
    Solicited Injection site: Tenderness (age < 23 months), Pain (age 4 to 6 years), Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability (age <23 months) Fever (temperature), Headache, Malaise, Myalgia (age 4 to 6 years). And unsolicited adverse events including serious adverse events.

Estimated Enrollment: 600
Study Start Date: June 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TETRAXIM™ vaccine
Participants will receive a primary or booster dose of TETRAXIM™
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
Other Name: TETRAXIM™

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

Ages Eligible for Study:   2 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01437423

Contact: Public Registry Sanofi Pasteur

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company ) Identifier: NCT01437423     History of Changes
Other Study ID Numbers: E2I59, U1111-1114-7745
Study First Received: September 19, 2011
Last Updated: September 4, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Whooping Cough
Actinomycetales Infections
Bacterial Infections
Bordetella Infections
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Clostridium Infections
Corynebacterium Infections
Enterovirus Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Spinal Cord Diseases
Virus Diseases processed this record on November 30, 2015