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NCT03165981 · ClinicalTrials.gov registry record · Phase 4
Fever After Simultaneous Versus Sequential Vaccination in Young Children
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 221
- Enrollment target
NCT03165981 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 221 participants.
The verdict
NCT03165981, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 221 participants
- Enrollment target
Study Summary
A prospective, randomized open-label clinical trial that will be conducted during the 2017-2018 influenza season. During the 2017-2018 season, approximately 280 children will be enrolled at Duke University Medical Center and Kaiser Permanente Northern California. Eligible children will be randomized to receive simultaneous or sequentially administered US licensed PCV13, US-licensed DTaP vaccine, and US-licensed inactivated influenza vaccine (IIV). Children in the simultaneous group will receive PCV13, DTaP, and IIV vaccines at Visit 1, and then return for a health education visit without vaccination about 2 weeks later (Visit 2). Children in the sequential group will receive both PCV13 and DTaP without IIV at Visit 1, and then will receive IIV and health education about 2 weeks later (Visit 2). Parents will record the occurrence of fever, solicited adverse events, medical care utilization, and receipt of antipyretics over 8 days following Visit 1 and Visit 2. In addition, febrile seizures and serious adverse events will be recorded for the entire study period (from enrollment through 8 days following the Visit 2) as determined through parental report and chart review. Parental perceptions about their child's vaccine schedule will be assessed on the 8th day following Visit 2.
Interventions
- BIOLOGICAL IIV
- BIOLOGICAL PCV13
- BIOLOGICAL DTaP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2017-08-25 |
| Est. Completion | 2018-01-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03165981
The ClinicalTrials.gov registry entry for NCT03165981 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 221 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 3 interventions - of which IIV is the first listed.
NCT03165981 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03165981 about?
NCT03165981 is a clinical study titled "Fever After Simultaneous Versus Sequential Vaccination in Young Children". A prospective, randomized open-label clinical trial that will be conducted during the 2017-2018 influenza season. During the 2017-2018 season, approximately 280 children will be enrolled at Duke University Medical Center and Kaiser Permanente Northern California. Eligible children will be randomized...
What is the current status of trial NCT03165981?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 221 participants. The study started on 2017-08-25. Estimated completion is 2018-01-15.
What interventions are being tested in trial NCT03165981?
The interventions under investigation include: IIV (BIOLOGICAL), PCV13 (BIOLOGICAL), DTaP (BIOLOGICAL).
Who is sponsoring clinical trial NCT03165981?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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