Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

Sanofi

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Tetanus; Pertussis

Treatments: Biological: DTaP vaccine; Biological: DTaP-IPV combined vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00319852

E2I28

Details and patient eligibility

About

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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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

Enrollment: 442 patients

Sex: All

Ages: 56 to 70 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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442 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: DTaP-IPV combined vaccine

2

Active Comparator group

Treatment:

Biological: DTaP vaccine