Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study - sIRB - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if there is any difference in the safety and effectiveness of flu and COVID-19 vaccines if they are given at the same time or 1-2 weeks apart.

What is the Condition Being Studied?

COVID-19 and Flu Vaccination

Who Can Participate in the Study?

Pregnant adults ages 18+ who:

  • Are less than 34 weeks pregnant
  • Already plan to get both flu and COVID-19 vaccines
  • Do not have any history of an allergic reaction to any type of vaccine

For more information, contact the study team at obresearch@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to either:

  • Get your COVID-19 and flu vaccinations on the same day; OR
  • Get the vaccines spaced out by 1-2 weeks from each other

Your participation in this study will end 90 days after you have your baby. You will visit our clinic up to 5 times during the study, and we will call you 3 times to check in on how you are doing. You will also have up to 4 blood draws during the study when you come in for your clinic visits.

Study Details

Full Title
Safety of Simultaneous versus Sequential Administration of mRNA COVID-19 Vaccine and Inactivated Influenza Vaccine (IIV) in Pregnant People - sIRB
Principal Investigator
Maternal-Fetal Medicine Specialist
Protocol Number
IRB: PRO00115925
NCT: NCT06503900
Phase
Phase IV
ClinicalTrials.gov
Enrollment Status
Open for Enrollment