Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
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ClinicalTrials.gov Identifier: NCT00319852 |
Recruitment Status :
Completed
First Posted : April 27, 2006
Last Update Posted : April 16, 2012
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The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea.
Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination.
Secondary objectives
- Immunogenicity: To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France). To assess and describe the immunogenicity of the study vaccines in both groups.
- Safety: To assess and describe the safety of the study vaccines after each dose.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pertussis Diphtheria Poliomyelitis Tetanus | Biological: DTaP-IPV combined vaccine Biological: DTaP vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 442 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Biological: DTaP-IPV combined vaccine
0.5 mL, IM
Other Name: TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis |
Active Comparator: 2 |
Biological: DTaP vaccine
0.5 mL, IM
Other Name: DTaP vaccine (CJ purified PDT vaccine ™) |
- To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines. [ Time Frame: 1 month post-vaccination ]

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Ages Eligible for Study: | 56 Days to 70 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Aged 56 to 70 days inclusive on the day of inclusion
- Born at full term pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by the parent(s) or other legal representative
- Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Blood or blood-derived products received in the past or planned administration during the trial (including immunoglobulins).
- Any vaccination in the 3 weeks preceding the first trial vaccination.
- History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases with the trial vaccine or another vaccine.
- Thrombocytopenia or a bleeding disorders contraindicating intramuscular vaccination
- History of major neurological diseases or seizures.
- Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) on the day of inclusion.
- Known family history of congenital or genetic immuno-deficiency.

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): NCT00319852
Korea, Republic of | |
Seoul, Korea, Republic of |
Study Director: | Clinical Trials | Sanofi Pasteur, a Sanofi Company |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00319852 |
Other Study ID Numbers: |
E2I28 |
First Posted: | April 27, 2006 Key Record Dates |
Last Update Posted: | April 16, 2012 |
Last Verified: | April 2012 |
Diphteria; Tetanus; Pertussis; Poliomyelitis; acellular |
Whooping Cough Tetanus Diphtheria Poliomyelitis 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 Nervous System 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 Neuromuscular Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |