Regulatory Post-Marketing Surveillance Study for TETRAXIM™
This study is currently recruiting participants.
Verified February 2013 by Sanofi
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01437423
First received: September 19, 2011
Last updated: February 5, 2013
Last verified: February 2013
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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: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel 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.
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | November 2015 |
| Estimated 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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437423
Contacts
| Contact: Public Registry Sanofi Pasteur | RegistryContactUs@sanofipasteur.com |
Locations
| Korea, Republic of | |
| Recruiting | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Director | Sanofi Pasteur SA |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01437423 History of Changes |
| Other Study ID Numbers: | E2I59, U1111-1114-7745 |
| Study First Received: | September 19, 2011 |
| Last Updated: | February 5, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Sanofi:
|
Diphtheria Tetanus Pertussis Poliomyelitis TETRAXIM™ |
Additional relevant MeSH terms:
|
Hypocalcemia Diphtheria Whooping Cough Poliomyelitis Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases |
Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations Calcium Metabolism Disorders |
ClinicalTrials.gov processed this record on May 21, 2013