Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00319852
First received: April 28, 2006
Last updated: April 13, 2012
Last verified: April 2012

April 28, 2006
April 13, 2012
April 2006
April 2008   (final data collection date for primary outcome measure)
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. [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00319852 on ClinicalTrials.gov Archive Site
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Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
Not Provided

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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pertussis
  • Diphtheria
  • Poliomyelitis
  • Tetanus
  • Biological: DTaP-IPV combined vaccine
    0.5 mL, IM
    Other Name: TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis
  • Biological: DTaP vaccine
    0.5 mL, IM
    Other Name: DTaP vaccine (CJ purified PDT vaccine ™)
  • Experimental: 1
    Intervention: Biological: DTaP-IPV combined vaccine
  • Active Comparator: 2
    Intervention: Biological: DTaP vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
442
July 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
56 Days to 70 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00319852
E2I28
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
Sanofi
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP