study to compare booster vaccination with pediacel® to infanrix® hexa when both are co-administered with prevenar®

Conditions: Infant; Healthy

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®. primary objective: to evaluate the safety of pediacel® booster dose co-administered with prevenar® to toddlers at 11-18 months of age. secondary objectives: * to describe the incidence rate of severe fever within four days post-vaccination * to describe the antibody responses to all antigens in a subgroup of subjects at baseline and post-vaccination.


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.

Keywords: diphtheria tetanus pertussis poliomyelitis haemophilus influenzae type b hepatitis b