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
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment