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NCT06503900 · ClinicalTrials.gov registry record · Phase 4
Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
A Phase 4 study of Safety and Birth Outcomes, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 98
- Enrollment target
- 6
- Study locations
NCT06503900: Completed Phase 4 study of Safety and Birth Outcomes, sponsored by Duke University.
NCT06503900 is a Phase 4 study of Safety and Birth Outcomes that has completed, run by Duke University. The registered enrollment target is 98 participants, below the 119-participant average among 10 other Safety trials with a reported enrollment target (18% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06503900, a Phase 4 study of Safety and Birth Outcomes, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 98 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Adverse birth outcome is defined as having at least one of the following: preterm birth (birth \<37 weeks), spontaneous abortion (loss prior to 20 weeks), fetal death (loss after 20 weeks), or neonatal death (death ≤ 28 days of life).
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 |
What the finished NCT06503900 record still lists
NCT06503900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 119-participant average among 10 other Safety trials with a reported enrollment target (18% lower).
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.
NCT06503900 lists 6 locations in 4 states (Georgia, North Carolina, Massachusetts).
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.
What interventions are being tested in trial NCT06503900?
The interventions under investigation include: mRNA COVID-19 vaccine (BIOLOGICAL), IIV4 (quadrivalent inactivated influenza vaccine) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06503900?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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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