EUCTR2006-000898-30-DEActive, not recruitingNot Applicable
Safety and Immunogenicity of Booster Vaccination with PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Booster Vaccination with Infanrix® hexa when Both Vaccines Are Co-Administered with Prevenar® to Toddlers 11-18 Months of Age
Sanofi Pasteur Incorporated0 sitesStarted: April 4, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. 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 9 months of life). The interval period between the 3rd dose of the primary series and the booster dose should be of at least 6 months.
- •2. Informed consent form signed by both parents or by the legal guardian.
- •3. Parents or legal guardian able to read and write the German language.
- •4. Parents or legal guardian able to attend all scheduled visits and to comply with study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Presence of fever (defined as rectal body temperature =38.0°C) reported within the last 72 hours
- •2. Moderate or severe acute illness with or without fever
- •3. Participation in another clinical trial in the 30 days preceding study vaccination.
- •4. Planned participation in another clinical trial during the present study period.
- •5. Immunisation with a pneumococcal vaccine prior to study vaccination or planned during the participation in the study.
- •6. Received more than 3 doses of a hexavalent vaccine prior to study vaccination.
- •7. Received any vaccination in the 30 days preceding the trial.
- •8. History of serological/microbiologically-confirmed diagnosis of infection due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
- •9. 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).
- •10. Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde).
- •11. 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.
- •12. Blood or blood-derived products (immunoglobulins) received during 3 months prior to study vaccination.
- •13. Known HIV seropositivity.
- •14. Known thrombocytopenia or a bleeding disorder contraindicating I.M. vaccination.
- •15. History of encephalopathy seizures or progressive, evolving or unstable neurological condition.
- •16. 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.
Investigators
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