Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
NCT ID: NCT00319852
Last Updated: 2012-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2006-04-30
2008-07-31
Brief Summary
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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
1. 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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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.
2. Safety: To assess and describe the safety of the study vaccines after each dose.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
DTaP-IPV combined vaccine
0.5 mL, IM
2
DTaP vaccine
0.5 mL, IM
Interventions
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DTaP-IPV combined vaccine
0.5 mL, IM
DTaP vaccine
0.5 mL, IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
56 Days
70 Days
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Seoul, , South Korea
Countries
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Related Links
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Related Info
Other Identifiers
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E2I28
Identifier Type: -
Identifier Source: org_study_id
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