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.
Who Can Participate?
Eligibility
Pregnant adults ages 18+ who:<ul>
<li>Are less than 34 weeks pregnant</li>
<li>Already plan to get both flu and COVID-19 vaccines</li>
<li>Do not have any history of an allergic reaction to any type of vaccine</li></ul>
For more information, contact the study team at <a href= "mailto: grace.davis@duke.edu">grace.davis@duke.edu.</a>
<li>Are less than 34 weeks pregnant</li>
<li>Already plan to get both flu and COVID-19 vaccines</li>
<li>Do not have any history of an allergic reaction to any type of vaccine</li></ul>
For more information, contact the study team at <a href= "mailto: grace.davis@duke.edu">grace.davis@duke.edu.</a>
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to either:<ul>
<li>Get your COVID-19 and flu vaccinations on the same day; OR</li>
<li>Get the vaccines spaced out by 1-2 weeks from each other</li></ul>
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.
<li>Get your COVID-19 and flu vaccinations on the same day; OR</li>
<li>Get the vaccines spaced out by 1-2 weeks from each other</li></ul>
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.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Geeta
Swamy
Protocol Number
PRO00115925
NCT ID
NCT06503900
Phase
IV
Enrollment Status
Open to Enrollment