Status:
COMPLETED
Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Pertussis
Diphtheria
Eligibility:
All Genders
80-120 years
Phase:
PHASE3
Brief Summary
Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Hae...
Eligibility Criteria
Inclusion
- Infants aged 80 to 120 days inclusive on the day of inclusion.
- Born at full term of pregnancy (\> 37 weeks)
- Informed consent form signed by the parent(s) or other legal representative according to local regulations
- Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).
Exclusion
- Rectal temperature ≥ 38.0°C
- Moderate or severe acute illness with or without fever
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
- History of a life-threatening reaction (such as encephalopathy, Hypotonic Hyporesponsive Episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances
- Blood or blood-derived products (immunoglobulins) received in the past 4 weeks
- Vaccination planned in the 6 weeks following any trial vaccination
- Known HIV seropositivity
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of seizures or progressive, evolving or unstable neurological condition
- Clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
807 Patients enrolled
Trial Details
Trial ID
NCT00287092
Start Date
February 1 2006
End Date
September 1 2008
Last Update
January 7 2015
Active Locations (14)
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1
Espoo, Finland, 02100
2
Helsinki, Finland, 00100
3
Helsinki, Finland, 00930
4
Jarvenpaa, Finland, 04400