Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
Condition: Diphtheria; Tetanus; Pertussis; Polio; Haemophilus Infection
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Tetany
Intervention: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 989.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: DAPTACEL®; PENTACEL™; Diphtheria; Tetanus; Pertussis; Haemophilus influenzae type b

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.
    

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.