Regulatory Post-Marketing Surveillance Study for TETRAXIM™
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ClinicalTrials.gov Identifier: NCT01437423 |
Recruitment Status :
Completed
First Posted : September 20, 2011
Results First Posted : January 4, 2017
Last Update Posted : March 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Tetanus Pertussis Poliomyelitis | Biological: TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: TETRAXIM™ vaccine
Participants will receive a primary or booster dose of TETRAXIM™
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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™ |
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437423
Korea, Republic of | |
Seoul, Korea, Republic of |
Study Director: | Medical Director | Sanofi Pasteur SA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
Results First Posted: | January 4, 2017 |
Last Update Posted: | March 28, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
Diphtheria Tetanus Pertussis Poliomyelitis TETRAXIM™ |
Whooping Cough Tetanus Diphtheria Poliomyelitis Tetany Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Respiratory Tract Infections 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 Myelitis Central Nervous System Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases Central Nervous System Diseases Spinal Cord Diseases |