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
  Purpose

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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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 Intervention Phase
Pertussis
Diphtheria
Poliomyelitis
Tetanus
Biological: DTaP-IPV combined vaccine
Biological: DTaP vaccine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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. [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 442
Study Start Date: April 2006
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 ™)

  Eligibility

Ages Eligible for Study:   56 Days to 70 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319852

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

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00319852     History of Changes
Other Study ID Numbers: E2I28
Study First Received: April 28, 2006
Last Updated: April 13, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Sanofi:
Diphteria;
Tetanus;
Pertussis;
Poliomyelitis;
acellular

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Hypocalcemia
Calcium Metabolism Disorders

ClinicalTrials.gov processed this record on July 29, 2014