Status:
COMPLETED
Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
Lead Sponsor:
Sanofi
Conditions:
Pertussis
Diphtheria
Eligibility:
All Genders
56-70 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT00319852
Start Date
April 1 2006
End Date
July 1 2008
Last Update
April 16 2012
Active Locations (1)
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1
Seoul, South Korea