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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 347 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06038617
The ClinicalTrials.gov registry entry for NCT06038617 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 347 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which mRNA COVID-19 Vaccine is the first listed.
NCT06038617 reports 0 study locations.
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.
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