Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women

Inclusion Criteria:

1. Pregnant, as determined by medical history; 18 - 45 years of age inclusive

2. Intention of receiving Tdap and IIV vaccines based on Advisory Committee on
Immunization Practices (ACIP) recommendations

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

4. Singleton gestation ≥ 26 weeks 0 days gestation - ≤32 weeks 0 days gestation at the
time of Visit 1 vaccination 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.

5. English or Spanish literate

6. Intention of being available for entire study period and complete all relevant study
procedures, including follow-up phone calls and collection of delivery information.

Exclusion Criteria:

1. For subjects enrolling during the 2016-2017 influenza season: IIV/LAIV receipt during
2016-2017 influenza season prior to study enrollment

2. For subjects enrolling during the 2017-2018 influenza season: IIV/LAIV receipt during
2017-2018 influenza season prior to study enrollment

2. Tdap/Td/TT receipt during current pregnancy prior to study enrollment 3. Has
immunosuppression as a result of an underlying illness or treatment, or use of
anti-cancer chemotherapy or radiation therapy within the preceding 36 months.

4. Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of
any hematologic malignancy, current bleeding disorder, or taking anticoagulants (daily
low dose aspirin may be acceptable).

5. Has a history of receiving immunoglobulin or other blood product (with exception of
Rhogam) within the 3 months prior to enrollment in this study.

6. Known to have pre-existing diabetes mellitus or an autoimmune disorder. 7. Febrile
illness within the last 24 hours or an oral temperature >/= 100.4°F (>/= 38.0°C) prior
to IIV or Tdap administration 8. Contraindication to IIV receipt including history of
severe allergic reaction after a previous dose of any influenza vaccine; or to a
vaccine component, including egg protein 9. Contraindication to Tdap receipt including
history of severe allergic reaction after a previous dose of any tetanus toxoid-,
diphtheria toxoid-, or pertussis antigen-containing vaccine or encephalopathy within 7
days of administration of a previous dose of a pertussis antigen-containing vaccine
that is not attributable to another identifiable cause 10. Arthus-type
hypersensitivity reaction following a prior dose of a tetanus toxoid-containing
vaccine within the last 10 years 11. Any condition that may interfere with assessment
of local injection site reactions, e.g. lymphadenectomy or obscuring tattoos 12.
History of Guillain-Barré syndrome within 6 weeks of a prior dose of any tetanus
toxoid-, diphtheria toxoid- or pertussis antigen-containing vaccine or influenza
vaccine 13. Known or suspected impairment of immunologic function including infection
with HIV, hepatitis B or C 14. Use of immunosuppressive or cytotoxic drugs except
receipt of oral or parenteral (intravenous, subcutaneous or intramuscular)
corticosteroids 30 or more days prior to enrollment. Persons who have used oral or
parenteral corticosteroids within 12 months prior to enrollment may be enrolled if the
longest course of therapy was less than 14 consecutive days and no dose was given
within 30 days of enrollment. Intraarticular, bursal, tendon, or epidural injections
of corticosteroids are permissible if the most recent injection was 30 or more days
prior to enrolment. Persons applying topically corticosteroid in either upper arm
(i.e. injection site) may be enrolled 1 or more days after their therapy is completed.
Corticosteroids administered topically at non-injection sites, by inhalation or
intranasally are permissible 15. Receipt of any licensed vaccine within 14 days prior
to study vaccination or planning receipt of any vaccines (except study vaccines) prior
to Visit 7 follow up.

16. Receipt of live vaccine during current pregnancy. 17. High risk for preterm birth
(active preterm labor, short cervix, cervical cerclage, receipt of antenatal
corticosteroids for fetal lung maturity prior to Visit 1) 18. Antenatal ultrasound
diagnosis of fetal growth restriction, defined as < 10th percentile estimated fetal
weight for gestational age 19. Known fetal congenital anomaly, e.g. genetic
abnormality or malformation based on antenatal ultrasound 20. 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.

21. Anyone who is a relative of any research study personnel 22. Anyone who is an
employee of any research study personnel 23. Anyone who is already enrolled or plans
to enroll in another clinical trial with an investigational product. Co-enrollment in
observational or behavioral intervention studies are allowed at any time.

24. Previous participation in the study.