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

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:
  • 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 Range

18-110

Sex/Genders

Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No

What is Involved?

Description

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.

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
ClinicalTrials.gov