Regulatory Post-Marketing Surveillance Study for TETRAXIM™

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01437423
First received: September 19, 2011
Last updated: January 4, 2016
Last verified: January 2016

September 19, 2011
January 4, 2016
June 2011
November 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01437423 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)
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.
Primary vaccination will be administered from 2 months and booster vaccination from age 4 to 6 years.
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis
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™
Experimental: TETRAXIM™ vaccine
Participants will receive a primary or booster dose of TETRAXIM™
Intervention: Biological: TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
2 Months to 6 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01437423
E2I59, U1111-1114-7745
No
Not Provided
Not Provided
Sanofi Pasteur, a Sanofi Company
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur SA
Sanofi
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP