Status:
COMPLETED
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Hepatitis B
Polio
Eligibility:
All Genders
50-71 years
Phase:
PHASE3
Brief Summary
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP\~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 m...
Eligibility Criteria
Inclusion
- Two-month old infants of either gender on the day of inclusion
- Born at full term of pregnancy (\>=37 weeks) with a birth weight \>=2.5 kg
- Informed consent form signed by the parent(s) or other legal representative(s) and an institution official other than an investigator
- 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 corticosteroid therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to 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 since birth
- Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination
- Vaccination planned in the 4 weeks following trial vaccination
- History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
- Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
- Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of seizures
- Febrile (axillary temperature 37.4°C \[rectal equivalent temperature \>=38.0°C\]) or acute illness on the day of inclusion.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00315055
Start Date
July 1 2006
End Date
February 1 2008
Last Update
September 12 2014
Active Locations (1)
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1
Ankara, Turkey (Türkiye)