Close Banner

We are delighted to welcome the former Lake Norman Regional Medical Center (LNRMC) in Mooresville, NC into the Duke Health family as Duke Health Lake Norman Hospital!

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