Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

Phase 3

Completed

• Conditions: Pertussis; Diphtheria; Poliomyelitis; Tetanus
• Interventions: Biological: DTaP-IPV combined vaccine; Biological: DTaP vaccine

• Registration Number: NCT00319852
• Lead Sponsor: Sanofi

Brief Summary

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

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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Posted: 2006-04-27
• Study First Submitted: 2006-04-28
• Study First Submitted QC: 2006-04-28
• Primary Completion: 2008-04
• Study Completion: 2008-07
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-13
• Last Update Posted: 2012-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DTaP-IPV combined vaccine	-
2	DTaP vaccine	-

Primary Outcome Measures

Name	Time	Method
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.	1 month post-vaccination