Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 757 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03183908
The ClinicalTrials.gov registry entry for NCT03183908 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 757 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 FLUAD® is the first listed.
NCT03183908 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.