Regulatory Post-Marketing Surveillance Study for TETRAXIM™

• ClinicalTrials.gov Identifier: NCT01437423
• Recruitment Status: Completed
• First Posted: September 20, 2011
• Results First Posted: January 4, 2017
• Last Update Posted: January 4, 2017
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Diphtheria; Tetanus; Pertussis; Poliomyelitis	Biological: TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio	Phase 4

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 600 participants
• Allocation: N/A
• 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)
• Study Start Date: June 2011
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

Arm	Intervention/treatment
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™

Outcome Measures

Primary Outcome Measures :

1. 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:

1. 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.
2. 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
3. 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.

Eligibility Criteria

• 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

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:

Related Info 

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT01437423
• Other Study ID Numbers: E2I59; U1111-1114-7745 ( Other Identifier: WHO )
• First Posted: September 20, 2011
• Results First Posted: January 4, 2017
• Last Update Posted: January 4, 2017
• Last Verified: November 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; Diphtheria; Poliomyelitis; Tetany; 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; 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; Neuromuscular Diseases