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NCT03183908 · ClinicalTrials.gov registry record · Phase 4
FLUAD® vs. Fluzone® High-Dose Study
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 757
- Enrollment target
NCT03183908: Completed Phase 4 study, sponsored by Duke University.
NCT03183908 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 757 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03183908, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 757 participants
- Enrollment target
Study Summary
The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons. During each season, approximately 220 older adults will be enrolled at Duke University Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then return for a second blood draw without vaccination about 4 weeks later to assess for influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6 months post-vaccination to assess for waning of influenza antibody titers. Subjects will record the occurrence of local and systemic reactions (including fever, pain, tenderness, swelling, redness, general systemic systems), unsolicited adverse events, medical care utilization, and changes in medications over 8 days following vaccination. In addition, serious adverse events and events of clinical interest will be assessed through 42 days post-vaccination. Health-related quality of life will be assessed pre-vaccination (Day 1) and on Days 3 and 9 post-vaccination.
Primary Outcome
Comparison of the proportion of subjects reporting moderate/severe injection site pain within the first week post-vaccination in both treatment groups.
Interventions
- BIOLOGICAL FLUAD®
- BIOLOGICAL Fluzone® High-Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 757 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2019-02-14 |
| Phase | Phase 4 |
What the finished NCT03183908 record still lists
NCT03183908 is an interventional study that assigns participants to a tested intervention. The registered 757 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 2 interventions - of which FLUAD® is the first listed.
NCT03183908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03183908 about?
NCT03183908 is a clinical study titled "FLUAD® vs. Fluzone® High-Dose Study". The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded clinical trial that will ...
What is the current status of trial NCT03183908?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 757 participants. The study started on 2017-08-28. Estimated completion is 2019-02-14.
What interventions are being tested in trial NCT03183908?
The interventions under investigation include: FLUAD® (BIOLOGICAL), Fluzone® High-Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT03183908?
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 NCT03183908's enrollment target sits among peer trials
757 106th of 2000 higher than 1,895 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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