Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: DAPTACEL®: DTaP; DAPTACEL®: DTaP
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 649.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: DAPTACEL®; Pentacel™; Diphtheria; Tetanus; Pertussis; Whooping cough; Acellular Pertussis Vaccine Adsorbed

Summary:

      Primary Objectives:

        1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of
           age who have previously received 4 doses of DAPTACEL® or Pentacel™.

        2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in
           DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of
           DAPTACEL® or Pentacel™.

      Observational Objectives:

        1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses
           to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously
           received 4 doses of DAPTACEL® or Pentacel™.

        2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.

        3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among
           subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a
           2nd dose of MMR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥ 4 and < 7 years from date of birth at the time of study vaccination

          -  Signed and dated Investigational Review Board (IRB)-approved informed consent from a
             parent or legally authorized representative. Signed and dated IRB-approved assent from
             subject if required by IRB

          -  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 the 4th dose of DAPTACEL® or Pentacel™ in
             Study P3T06 (i.e., 4 previous administrations of DAPTACEL® or Pentacel™).

        Exclusion Criteria:

          -  Received a 5th dose of DTaP-containing vaccine

          -  a. For subjects in the DAPTACEL® arm: Received a 4th dose of Inactivated Poliovirus
             Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (MMR) vaccine
             scheduled at 4 to 6 years of age.

             b. For subjects in the Pentacel™ arm: Received a 2nd dose of MMR vaccine scheduled at
             4 to 6 years of age

          -  Severe hypersensitivity to any component of the vaccine such as an anaphylactic
             reaction observed following a previous vaccination

          -  Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus;
             malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or
             hematologic disorder·Unstable or evolving neurologic disorders that may predispose the
             subject to seizures or neurologic deterioration. These may include progressive
             neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy)
             and encephalopathy within 7 days following previous vaccination

          -  Known or suspected primary or acquired disease of the immune system

          -  Administration of immune globulin, other blood products within the last 3 months,
             injected or oral corticosteroids or other immunomodulator therapy within 6 weeks prior
             to study vaccination. 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
             4 weeks prior to study vaccination

          -  Receipt of any other vaccine within 30 days prior to study vaccination, or planning to
             receive another vaccine within 30 days before the Visit 2 blood draw (if applicable)

          -  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.