Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00319852
First received: April 28, 2006
Last updated: April 13, 2012
Last verified: April 2012
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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
- 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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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 | 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 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 June 18, 2013