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Trial record 1 of 1 for:    E2I28
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Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

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ClinicalTrials.gov Identifier: NCT00319852
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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

Condition or disease Intervention/treatment Phase
Pertussis Diphtheria Poliomyelitis Tetanus Biological: DTaP-IPV combined vaccine Biological: DTaP vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : April 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : July 2008

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   56 Days to 70 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319852


Locations
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Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
More Information
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Additional Information:

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00319852    
Other Study ID Numbers: E2I28
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: April 16, 2012
Last Verified: April 2012
Keywords provided by Sanofi:
Diphteria;
Tetanus;
Pertussis;
Poliomyelitis;
acellular
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Poliomyelitis
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Nervous System Diseases
 Corynebacterium Infections
Actinomycetales Infections
Myelitis
Central Nervous System Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs