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Virus Therapy

COVID-19 and Flu Vaccines for Pregnant Women

Phase 4
Waitlist Available
Led By Geeta Swamy, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant people ages 18 years or older at enrollment
Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of delivery information
Must not have
History of multisystem inflammatory syndrome in children (MIS-C) or multisystem inflammatory syndrome in adults (MIS-A)
Known fetal congenital anomaly, e.g., genetic abnormality or major congenital malformation based on antenatal ultrasound
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days post visit 1, up to 7 days post visit 2
Awards & highlights

Summary

This trial will study pregnant participants who will receive both the influenza vaccine and the mRNA COVID-19 vaccine either at the same time or a few days apart. The participants will report any symptoms they experience after

Who is the study for?
This clinical trial is for pregnant individuals who are willing to receive both the mRNA COVID-19 vaccine and the IIV4 influenza vaccine. Participants will be monitored through delivery and up to 90 days post-delivery, with eligibility criteria not fully disclosed in the provided information.
What is being tested?
The study tests whether getting an mRNA COVID-19 vaccine at the same time as an IIV4 flu shot affects safety or birth outcomes differently than getting them separately (7-14 days apart). It's a randomized trial where participants' symptoms are tracked closely after vaccination.
What are the potential side effects?
Possible side effects include local reactions at injection sites, systemic symptoms like fever or fatigue following vaccinations, serious adverse events, and special interest events related to pregnancy and infant health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am pregnant and 18 years or older.
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I plan to participate in the entire study and follow all procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had MIS-C (if a child) or MIS-A (if an adult).
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My unborn baby has been diagnosed with a genetic issue or major birth defect.
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I haven't taken strong immune system drugs for more than 2 weeks in the last 6 months.
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I have received the flu vaccine for the current season.
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I am experiencing early signs of labor before 37 weeks of pregnancy.
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I haven't had a fever over 100.4°F in the last 3 days.
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I am currently battling cancer, excluding nonmelanoma skin cancers, and may have received cancer treatment during my current pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days post visit 1, up to 7 days post visit 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days post visit 1, up to 7 days post visit 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with an adverse birth outcome
Secondary study objectives
Number of participants with combined fetal/neonatal death
Number of participants with moderate or more severe fever, chills, myalgia, or arthralgia
Number of participants with moderate or more severe systemic reactogenicity events (including injection site pain/swelling/redness, fever, malaise, chills)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Simultaneous Vaccination GroupExperimental Treatment2 Interventions
Subjects will receive a dose of mRNA COVID-19 vaccine and IIV at Visit 1.
Group II: Sequential Vaccination GroupExperimental Treatment2 Interventions
Subjects will receive a dose of mRNA COVID-19 vaccine at Visit 2 and a dose of IIV at Visit 2.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,065,734 Total Patients Enrolled
2 Trials studying Safety
384 Patients Enrolled for Safety
Geeta Swamy, MDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
4,072 Total Patients Enrolled
Elizabeth Barnett, MDPrincipal InvestigatorBoston Medical Center
1 Previous Clinical Trials
757 Total Patients Enrolled
~233 spots leftby Feb 2026
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