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NCT06038617 · ClinicalTrials.gov registry record · Phase 4
Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 347
- Enrollment target
NCT06038617: Completed Phase 4 study, sponsored by Duke University.
NCT06038617 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 347 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06038617, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 347 participants
- Enrollment target
Study Summary
This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits (Visits 1 and 2). Parent(s) or legal authorized representative(s) (LAR) will assess fever and other solicited systemic adverse events on the day of vaccination (Day 1) and the next 6 days (through Day 7) following Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid. Serious adverse events and adverse events of special interest will be captured during the entire study period. Parental/LAR perceptions about their child's vaccine schedule will be assessed on Day 7 following Visit 2.
Primary Outcome
Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.
Interventions
- BIOLOGICAL mRNA COVID-19 Vaccine
- BIOLOGICAL Routine Childhood Vaccinations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2023-10-30 |
| Est. Completion | 2025-07-25 |
| Phase | Phase 4 |
What the finished NCT06038617 record still lists
NCT06038617 is an interventional study that assigns participants to a tested intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which mRNA COVID-19 Vaccine is the first listed.
NCT06038617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06038617 about?
NCT06038617 is a clinical study titled "Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children". This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits (Visits 1 and 2). Parent(...
What is the current status of trial NCT06038617?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 347 participants. The study started on 2023-10-30. Estimated completion is 2025-07-25.
What interventions are being tested in trial NCT06038617?
The interventions under investigation include: mRNA COVID-19 Vaccine (BIOLOGICAL), Routine Childhood Vaccinations (BIOLOGICAL).
Who is sponsoring clinical trial NCT06038617?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06038617's enrollment target sits among peer trials
347 241st of 2000 higher than 1,759 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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