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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
  Purpose
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
Diphtheria Tetanus Pertussis Poliomyelitis Biological: TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 600
Study Start Date: June 2011
Study Completion Date: November 2015
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.
  Eligibility

Ages Eligible for Study:   2 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01437423

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

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01437423     History of Changes
Other Study ID Numbers: E2I59
U1111-1114-7745 ( Other Identifier: WHO )
Study First Received: September 19, 2011
Results First Received: November 6, 2016
Last Updated: November 6, 2016
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Diphtheria
Tetanus
Pertussis
Poliomyelitis
TETRAXIM™

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Tetany
Diphtheria
Poliomyelitis
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases

ClinicalTrials.gov processed this record on September 21, 2017