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
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group 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.


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)
Genders Eligible for Study:   Both
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 
Study First Received: September 19, 2011
Last Updated: January 4, 2016
Health Authority: Korea: Food and Drug Administration

Keywords provided by Sanofi:
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 July 24, 2016