Flu Vaccine in Pregnancy Study for Women Up to 34 Weeks Pregnant

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to compare the health effects of two licensed influenza vaccines that are currently recommended for use in pregnant women. Flublok® (recombinant quadrivalent influenza vaccine) is a type of flu vaccine that is made using an egg-free process. Flulaval® is made using an egg-based process which has been in use for years.

Who can participate?

Pregnant women who are at least 18 years old and are:

  • Up to 34 weeks pregnant

and

  • Planning to receive the influenza (flu) vaccine as recommended for routine prenatal care

Conditions

  • Healthy Adults
  • Pregnancy
  • Vaccines

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:

You will:

  • 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.

What are the bad things that can happen from this research?

There is minimal risk to participating in this study because both of the flu vaccines that you would receive have already been approved by the FDA (Food and Drug Administration) and CDC (Centers for Disease Control and Prevention). You could have possible discomforts from receiving the vaccine such as redness, swelling, tenderness, pain at the site of injection, fever, chills, etc. The possible risks and discomforts will be discussed with those wanting to learn more about the study.

Will you/your child be paid to be in this research study?

Participants may receive up to $225 for time and effort.

Contact

Contact Us.Study Coordinator
513-803-8800 (select option #9)
idstudies@cchmc.org
Infectious Diseases
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Elizabeth Schlaudecker, MD, MPH
Cincinnati Children’s Hospital Medical Center

Emily DeFranco, DO
University of Cincinnati Medical Center