study of daptacel® administered as a 5th dose in 4 to 6-year-old children previously immunized with pentacel™

Conditions: Diphtheria; Tetanus; Pertussis; Polio; Haemophilus Infection

Summary: objectives: * to present the rates of adverse reactions after a dose of daptacel® vaccine administered to children 4 to 6 years of age who have previously received four doses of pentacel™ vaccine. * to present immunogenicity before and after a single dose of daptacel® vaccine administered to children 4 to 6 years of age who have previously received four doses of pentacel™ vaccine.

this study is designed to assess the safety and immunogenicity of daptacel® vaccine administered at 4 to 6 years of age according to the us standard of care. the study population consists of pentacel™-primed subjects from aventis pasteur's pivotal studies 494-01 and 494-03. these children will receive daptacel® vaccine as a 5th dose immunization between 4 to 6 years of age.

Eligibility criteria:
inclusion criteria : * aged ≥ 4 years and 6 years. * signed and dated investigational review board-approved informed consent from a parent or legally authorized representative. * judged to be in good health on the basis of reported medical history and physical examination. * able and willing to attend the scheduled visits and to comply with the study procedures. * has documented complete infant series and 4th dose in study 494-01 or study 494-03, consisting of four previous administrations of pentacel™. exclusion criteria : * received a 5th dose of dtap-containing vaccine scheduled at 4 to 6 years of age. * serious underlying chronic disease, including, but not limited to: * diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder; or * unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. * known or suspected primary or acquired disease of the immune system. * administration of immune globulin or other blood products within the last 3 months, or injected or oral corticosteroids or other immunomodulatory therapy within 6 weeks of the study vaccine. individuals on a tapering dose schedule of oral steroids lasting \<7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment. * had allergy shots started or had changes in regimen or dosing of allergy shots within the last 4 weeks. * receipt of any other vaccine within the past 30 days, or planning to receive another vaccine within 30 days before the visit 2 blood draw, with the exclusion of m-m-r®ii and ipv. * any other condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. * enrolled in another vaccine trial. * personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months. * known or suspected allergy to any of the vaccines or vaccine components intended for use in this study. temporary contraindications: * a subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms: oral temperature ≥ 100.4°f (≥ 38.0ºc) (note: a tympanic thermometer should not be used). * any moderate or severe acute illness with or without fever.

Keywords: daptacel® pentacel™ diphtheria tetanus pertussis haemophilus influenzae type b