Tdap Vaccine in Post-Partum Women
Condition: Diphtheria; Pertussis; Tetanus
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate
Intervention description: 55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).
Intervention MeSH terms: Aluminum phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Enrollment: 55.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acellular; Adacel®; Diptheria toxoids; Pertussis; postpartum; Tdap; Tetanus; women

Summary:

      Monitoring immune response and longevity in serum and milk after Tdap administration to
      postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just
      delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at
      Vanderbilt University Medical Center. The enrollment period will be fifteen months. The
      duration is over two years of observation.
    

Eligibility criteria:

        Inclusion Criteria:

        -Healthy, postpartum women as determined by medical history aged 18 - 45 years of age
        inclusive. -Women 1-4 days postpartum from delivery of full-term infants. Full-term will be
        defined as estimated gestational age of greater than or equal to 37 completed weeks of
        pregnancy determined by menstrual dating and concordant with ultrasound findings as per
        ACOG bulletin #101). -Provide written informed consent prior to initiation of any study
        procedures. -Available for the entire study period. -Able to understand and complete all
        relevant study procedures during study participation (women who ultimately have limited
        ability to breast feed after enrollment will not be excluded from the study).

        Exclusion Criteria:

        -Prior receipt of a tetanus or diphtheria-containing vaccine within two years of
        enrollment. -Prior receipt of a tetanus and diphtheria toxoid and acellular pertussis
        vaccine within two years of enrollment. -Known or suspected impairment of immunologic
        function. -Febrile illness within the last 24 hours or an oral temperature >/= 100.4
        degrees F (>/= 38 degrees C) at the time of enrollment. -History of documented tetanus,
        diphtheria, or pertussis disease within the preceding 5 years. -History of allergic or
        adverse reaction to diphtheria, tetanus, or pertussis vaccines. -Receipt of any steroids,
        immunoglobulins, other blood products/transfusion within the past six months- excluding Rh
        immunoglobulin (Rhogam™ and Rhophylac™). -Is enrolled or plans to enroll in another
        clinical trial with an investigational product while participating in this study
        (observational studies are allowed). -Known active infection with HIV, hepatitis B, or
        hepatitis C. -History of alcohol or drug abuse in the last 5 years. -Any condition which,
        in the opinion of the investigators, may pose a health risk to the subject or interfere
        with the evaluation of the study objectives. -Any woman with health condition who is
        currently taking glucocorticoids, i.e., oral, parenteral, and high-dose inhaled steroids,
        and immunosuppressive or cytotoxic drugs. -Sensitive to latex, based on package insert
        -Progressive or unstable neurologic condition, based on package insert. -Receipt of
        influenza or other vaccines concomitantly administered or for 42 days following Adacel,
        based on package insert.