Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With 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.