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Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
NCT06503900 · View on ClinicalTrials.gov ↗
Study Summary
This study is a prospective, randomized clinical trial. During this study, pregnant women 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 women 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.
Conditions Studied
Interventions
- BIOLOGICAL mRNA COVID-19 vaccine
- BIOLOGICAL IIV4 (quadrivalent inactivated influenza vaccine)
Study Locations (6)
Georgia
- Emory University — Atlanta
- Centers for Disease Control and Prevention — Atlanta
North Carolina
- Duke University — Durham
- Wake Forest University — Winston-Salem
Massachusetts
- Boston Medical Center — Boston
Ohio
- Elizabeth Schlaudecker — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2024-09-12 |
| Est. Completion | 2025-11-19 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06503900
The ClinicalTrials.gov registry entry for NCT06503900 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Safety appearing as the primary indexed condition, and to 2 interventions — of which mRNA COVID-19 vaccine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06503900 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Georgia, North Carolina, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06503900 about?
NCT06503900 is a clinical study titled "Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study". This study is a prospective, randomized clinical trial. During this study, pregnant women 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 ...
What is the current status of trial NCT06503900?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 98 participants. The study started on 2024-09-12. Estimated completion is 2025-11-19.
What conditions does trial NCT06503900 study?
This clinical trial studies the following conditions: Safety, Birth Outcomes, Adverse Event Following Immunization. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06503900?
The interventions under investigation include: mRNA COVID-19 vaccine (BIOLOGICAL), IIV4 (quadrivalent inactivated influenza vaccine) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06503900?
This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06503900 being conducted?
This trial has 6 study locations across Georgia, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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