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Virus Therapy

Sequential Vaccination Group for Safety

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
* Gestational age \< 34 weeks 0 days based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA-EDD) will be based on reconciliation of "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
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 study is a prospective, randomized clinical trial. During this study,pregnant participants will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart). All participants will receive an mRNA COVID-19 vaccine at Visit 1 (Day 1). Solicited local and systemic symptoms of reactogenicity will be assessed on day of visit for Visits 1 and 2 and daily during the 6 days following each visit using either electronic or paper symptoms diaries, depending on study participant preference. Serious adverse events (SAE) and adverse events of special interest (AESI) will be collected throughout the duration of the study. Pregnant people will be followed through delivery with comprehensive obstetric and infant outcomes obtained from medical record review for 90 days post-delivery. Maternal serum samples will be collected for antibody titers relevant to Influenza and COVID-19 prior to vaccination, at Day 29 (both groups), as well as Days 36-43 if in sequential group. When feasible, maternal blood at delivery and cord blood serum will be analyzed for serological analyses of placental influenza and COVID-19 antibody transfer (cord blood: maternal antibody ratio) will be determined.

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

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
2,420 Previous Clinical Trials
3,064,403 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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