Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

Tetanus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319852
• Other study ID #: E2I28
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2006
• Last updated: April 13, 2012
• Start date: April 2006
• Est. completion date: July 2008

Study information

• Verified date: April 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 56 Days to 70 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• DTaP-IPV combined vaccine
0.5 mL, IM
• DTaP vaccine
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Link
•   Link