Status:
COMPLETED
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
55-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age. Primary Objectives: * To compare the post-dose 3 ...
Eligibility Criteria
Inclusion
- Infants 55 to 75 days old, inclusive on the day of first vaccination
- Born at full term of pregnancy (\> 37 weeks)
- Informed consent form signed by the parent(s) or the legal guardian
- Parents or the legal guardian able to read and write in the local language
- Parent(s) or the legal guardian able to attend all scheduled visits and to comply with the study procedures.
Exclusion
- Presence of fever (defined as rectal body temperature ≥ 38.0°C) reported within the last 72 hours
- Moderate or severe acute illness with or without fever
- Participation in another clinical trial in the 30 days preceding first study vaccination
- Planned participation in another clinical trial during the present study period
- Received diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination
- Received any vaccination in the 30 days preceding the first study vaccination and/or is planning any vaccination within 6 weeks following any of the study vaccinations
- Congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (≥ 2 mg/kg/day prednisone equivalent for ≥ 14 days) in the previous 30 days
- Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
- History of life-threatening reaction(s) (such as encephalopathy, Hypotonic-Hyporesponsive Episode, rectal body temperature ≥ 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines
- Blood or blood-derived products (immunoglobulins) received since birth
- Known Human immunodeficiency virus (HIV) seropositivity
- Known thrombocytopenia or other bleeding disorder contraindicating intramuscular vaccination
- History of encephalopathy, seizures or progressive, evolving or unstable neurological condition
- Clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the study vaccine/objectives or pose a health risk to the subject.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
588 Patients enrolled
Trial Details
Trial ID
NCT00343421
Start Date
July 1 2006
End Date
June 1 2009
Last Update
June 3 2016
Active Locations (2)
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1
Paris, France
2
Poznan, Poland