Who can participate?
Pregnant women who are at least 18 years old and are:
- Planning to receive the influenza (flu) vaccine as recommended for routine prenatal care
What will happen in the study?
You will be in the study for 3 to 7 months, with 2 study visits at Cincinnati Children’s and 4 follow-up phone calls. Here are some of the things that will happen in this study:
- Be randomly assigned (like flipping a coin) to either receive the egg-free recombinant influenza vaccine (RIV) or egg-based inactivated influenza vaccine (IIV)
- Have a blood draw at both study visits
- Record your health information for the first 8 days after you receive the vaccine
- Let the study team know about any changes in your health or the way you feel.Sign a medical release to allow study staff to review your baby’s medical records
- Maybe have an additional blood sample collected, as well as a cord blood sample, if you deliver at UCMC
You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
You will receive the flu vaccine at no charge, and the benefits are expected to be the same as they would be if you received the flu vaccine as part of your usual prenatal care. Also, you may develop protective antibodies against the flu.
Overall, the information we learn from this study may help doctors better understand if there is a difference in health effects and immune response between the two vaccines during pregnancy. Also, the information can help researchers to perform future vaccine studies during pregnancy in the future.