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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: November 6, 2016
Last verified: November 2016
September 19, 2011
November 6, 2016
June 2011
November 2015   (Final data collection date for primary outcome measure)
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. [ Time Frame: Up to 30 days post-primary and booster vaccination ]
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.
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 ]
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.
Complete list of historical versions of study NCT01437423 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. [ Time Frame: Up to 30 days post-primary and booster vaccination ]
    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.
  • Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. [ Time Frame: Up to 30 days post-primary and booster of TETRAXIM™ vaccination ]
    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
  • Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. [ Time Frame: Up to 30 days post-primary and booster of vaccination ]
    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.
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
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.
Sexes Eligible for Study: All
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 ( Other Identifier: WHO )
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi.
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur SA
Sanofi
November 2016

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