Tdap Vaccine in Post-Partum Women

This is a single site, prospective study involving only one intervention, receipt of a
single 0.5 mL intramuscular (IM) dose of Adacel (Tetanus toxoid, reduced diphtheria toxoid
and acellular Pertussis) vaccine, among 55 healthy post partum women. The purpose of the
study is to examine the immune responses and subsequent decline in serum and breast milk
antibody titers over two years of observation. 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. One particular
population at Vanderbilt to target will be the "centering prenatal care group" that has
breastfeeding rates as high as 75 percent at hospital discharge and maintained at 20 percent
at 6 months. The enrollment period will be fifteen months. The subjects, staff assessing
subjects, and laboratory personnel will be aware of receipt of the vaccine. Since only a
single vaccine product is being utilized, there is no blinding needed of the subjects or
staff.

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.