Status:
COMPLETED
Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Infant
Healthy
Eligibility:
All Genders
11-18 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®. Pr...
Eligibility Criteria
Inclusion
- Toddlers 11-18 months of age (from the 11th month birthday to one day prior to the 19th month birthday) who previously received the primary immunisation series with a hexavalent vaccine (consisting of three doses of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenza type b combined vaccine administered within the first 6 months of life)
- Informed consent form signed by both parents or by the legal guardian
- Parents or a legal guardian able to read and write the local language
- Parents or a 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 study vaccination
- Planned participation in another clinical trial during the present study period
- Immunisation with a pneumococcal vaccine prior to study vaccination or planned during the participation in the study
- Received more than 3 doses of a hexavalent vaccine prior to study vaccination
- Received any vaccination in the 30 days preceding the trial
- History of serological/microbiologically-confirmed diagnosis of infection due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae
- 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 30 days prior to study vaccination)
- Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
- History of a life-threatening reaction (such as encephalopathy, Hypotonic-Hyporesponsive Episode (HHE), 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 during 3 months prior to study vaccination
- Known HIV seropositivity
- Known thrombocytopenia or a 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 :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
847 Patients enrolled
Trial Details
Trial ID
NCT00355654
Start Date
September 1 2006
End Date
July 1 2008
Last Update
January 7 2015
Active Locations (84)
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1
Aalen, Germany, 73433
2
Aisch, Germany, 91413
3
Alsfeld, Germany, 36304
4
Augsburg, Germany, 86150