TDAP Safety in Pregnant Women

This is an observational study of both pregnant and non-pregnant women. Vaccine
administration in the pregnant population will be part of routine care. Vaccine
administration in the non-pregnant women will be provided as either routine care or as part
of the study. Pregnant women at ≥ 20 weeks 0 days gestation who have not received Tdap during
the current pregnancy will be enrolled, with prioritized emphasis on enrolling pregnant women
who have received Tdap prior to the current pregnancy in order to attempt to address the
question of closely-spaced repeated dosing. Detailed data will be collected from study
participants on prior Tdap/Td/TT receipt. The non-pregnant women will consist of both Tdap
naïve and those who have received Tdap previously. With Day 0 serving as the day of
vaccination, participants will be followed through Day 7 for symptoms of reactogenicity. For
Primary Objective 1, symptoms of reactogenicity occurring from Day 0 -7 will be compared
between pregnant and non-pregnant women. For Objective 2, pregnant women will be followed
through delivery for collection of pregnancy outcome data. Pregnancy outcomes among study
participants will be compared with historical outcomes from summary data from both Vanderbilt
and Duke. In addition, follow-up will be conducted for infants born to mothers who received
Tdap during pregnancy to assess health outcomes and growth parameters through 6 months of
life.

Inclusion:

Subjects who meet the following criteria will be eligible to participate in this
observational study. Tdap administration will be given as routine standard of care.

- Pregnant and non-pregnant women, as determined by medical history, aged 18 - 45 years
of age inclusive

- For pregnant women only - Singleton gestation ≥ 20 weeks 0 days gestation - ≤34 weeks
0 days gestation based on reconciliation of last menstrual period and ultrasound
dating. Estimated due date (EDD) and Gestational Age (GA) - EDD will be based on
reconciliation of a "sure" first day of the last menstrual period (LMP) and earliest
dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will
be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with
sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the
ultrasound derived EDD is not in agreement with the LMP-derived EDD, the
ultrasound-derived EDD is used to determine GA.

- Intention of receiving Tdap vaccine based on ACIP guidelines

- Willing to provide written informed consent prior to initiation of any study
procedures

- English or Spanish literate

- Intention of being available for entire study period and complete all relevant study
procedures

Exclusion:

- Subjects who meet the following criteria will not be eligible to participate in this
study:

- Febrile illness within the last 24 hours or an oral temperature > 100.4oF (> 38oC)
prior to Tdap administration

- Severe allergic reaction (e.g., anaphylaxis) to any component of Tdap or any other
diphtheria toxoid, tetanus toxoid and pertussis antigen containing vaccine

- Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures)
within 7 days of administration of a previous pertussis antigen-containing vaccine.

- Known or suspected impairment of immunologic function including active infection with
HIV, hepatitis B or C, current use of glucocorticoids, i.e., oral, parenteral, and
high-dose inhaled steroids, and immunosuppressive or cytotoxic drugs.

- Note, if a woman were to require antenatal corticosteroids for benefit of fetal lung
maturity within 8 days post enrollment, she would not be excluded from the study for
reactogenicity analysis. However, if antenatal corticosteroids were received anytime
between vaccination and 28-day sample collection for serologic studies, she would be
excluded from serologic studies as they could be altered by steroid receipt.

- Receipt of any licensed vaccine OR investigational product within 1 week prior to Tdap
vaccination in this study or planning receipt of any vaccines during 8-day
post-vaccination period.

- Note, any woman receiving an investigational vaccine or live vaccine inadvertently at
any time during pregnancy will be excluded from analysis. (Note, inadvertent receipt
of licensed HPV vaccine or any other inactivated licensed vaccine outside of the
parameters specified above is not a reason for exclusion).

- 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.

- Anyone who is a relative of any research study personnel

- Anyone who is an employee of any research study personnel

- For pregnant women only

- Tdap/Td/TT receipt during current pregnancy prior to study enrollment

- Signs or symptoms of active preterm labor, defined as regular uterine contractions
with cervical change

- For non-pregnant women only

- Intention of becoming pregnant during study participation

- Anyone who is already enrolled or plans to enroll in another clinical trial with an
investigational product within 30 days of Tdap receipt. Co-enrollment in observational
or behavioral intervention studies are allowed at any time while enrollment in a
clinical trial involving an investigational product (other than vaccine) may occur
after 30 days following Tdap receipt. Receipt of inactivated vaccines during
pregnancy, including routinely recommended inactivated influenza vaccine, given as
part of usual care, is not an exclusion for this study, except during the 8 days after
Tdap vaccination