Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Jul 20, 2006

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.

Trial Officials