Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00319852

Collaborator

(none)

442

Enrollment

Location

Arms

Duration (Months)

16.4

Patients Per Site Per Month

Study Details

Study Description

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

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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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

Study Type:

Interventional

Actual Enrollment :

442 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: DTaP-IPV combined vaccine 0.5 mL, IM Other Names: TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis
Active Comparator: 2	Biological: DTaP vaccine 0.5 mL, IM Other Names: DTaP vaccine (CJ purified PDT vaccine ™)

Arm

Intervention/Treatment

Experimental: 1

Biological: DTaP-IPV combined vaccine

0.5 mL, IM

Other Names:

TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis

Active Comparator: 2

Biological: DTaP vaccine

0.5 mL, IM

Other Names:

DTaP vaccine (CJ purified PDT vaccine ™)

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

56 Days to 70 Days

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.