Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Duke University.
NCT03165981 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 221 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion 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 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 |
What the finished NCT03165981 record still lists
NCT03165981 is an interventional study that assigns participants to a tested intervention. The registered 221 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 (57% lower).
The record links to 0 conditions, and to 3 interventions - of which IIV is the first listed.
NCT03165981 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03165981's enrollment target sits among peer trials
221 383rd of 2000 higher than 1,616 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03170440 · 221 participants · NA
Non-invasive Nerve Stimulation for PTSD and Sleep
- NCT04939610 · 222 participants · Phase 1
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
- NCT05424783 · 222 participants
MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)
- NCT05568264 · 222 participants · NA
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI