Safety of RIV4 Versus IIV4 in Pregnant Women

Exclusion Criteria

• •1. Influenza vaccine receipt during 2019-2020 or 2020-2021 influenza season prior to study enrollment.
• •2. Participation in this study in 2019-2020 influenza season
• •3. Any condition that may interfere with assessment of local injection site reactions, e.g. obscuring tattoos
• •4. Known or suspected immunosuppression as a result of an underlying illness or treatment
• •5. Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months
• •6. Use of oral or parenteral corticosteroids (≥ 20mg/day prednisone equivalent) or high-dose inhaled glucocorticoid for ≥ 14 consecutive days within the preceding 30 days
• •7. Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants (a daily aspirin is acceptable)
• •8. Has a history of receiving immunoglobulin or other blood product (with exception of Rh immunoglobulin) within the 3 months prior to study vaccination.
• •9. History of febrile illness (\> 100.4°F or 38°C) within the past 24 hours prior to study vaccination
• •10. Contraindication to IIV or RIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component, including egg protein
• •11. History of Guillain-Barré syndrome within 6 weeks of a prior dose of any influenza vaccine
• •12. Receipt of any licensed vaccine within 7 days prior to study vaccination or intention of receiving any vaccines during 8-day post-vaccination period
• •13. Receipt of live vaccine during current pregnancy
• •14. Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change (dilation/effacement)
• •15. Known multi-fetal gestation or fetal congenital anomaly, e.g. genetic abnormality or major congenital malformation based on antenatal ultrasound
• •16. Anyone who is already enrolled or plans to enroll in another randomized clinical trial with any drug, vaccine or medical device. Co-enrollment in observational or behavioral intervention studies are allowed at any time
• •17. Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives.
• •18. Anyone who is a relative of any research study personnel or is an employee supervised by study staff