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NCT05007041 · ClinicalTrials.gov registry record · Phase 4
Simultaneous RZV and aIIV4 Vaccination
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 267
- Enrollment target
NCT05007041: Completed Phase 4 study, sponsored by Duke University.
NCT05007041 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 267 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05007041, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 267 participants
- Enrollment target
Study Summary
The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Fluzone® High-Dose Quadrivalent vaccine in persons age ≥65 years. A prospective, randomized, blinded clinical trial that will be conducted during the 2021/2022 and 2022/2023 influenza seasons. Over the course of these two influenza seasons, approximately 220 older adults will be enrolled at Duke University Medical Center, and 180 older adults at Johns Hopkins University Medical Center. Eligible subjects will be randomized to receive either simultaneous RZV/FLUAD® or RZV/Fluzone® High-Dose vaccines. All subjects will be assessed for 7 days post-injection and safety and tolerability compared between the two groups. Serious adverse events and adverse events of clinical interest will be assessed 42 days post-vaccination and compared between the two groups. Health-related quality of life will be assessed pre-vaccination Day 1 through Day 8. Serious Adverse Events and Adverse Events of Clinical Interest were also assessed throughout the study period.
Primary Outcome
Modified Intention-to-Treat (mITT) Population
Interventions
- BIOLOGICAL FLUAD® Quadrivalent
- BIOLOGICAL Fluzone® High-Dose Quadrivalent
- BIOLOGICAL SHINGRIX®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2021-09-21 |
| Est. Completion | 2023-06-08 |
| Phase | Phase 4 |
What the finished NCT05007041 record still lists
NCT05007041 is an interventional study that assigns participants to a tested intervention. The registered 267 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 (48% lower).
The record links to 0 conditions, and to 3 interventions - of which FLUAD® Quadrivalent is the first listed.
NCT05007041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05007041 about?
NCT05007041 is a clinical study titled "Simultaneous RZV and aIIV4 Vaccination". The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Fluzone® High-Dose Quadrivalent vacc...
What is the current status of trial NCT05007041?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 267 participants. The study started on 2021-09-21. Estimated completion is 2023-06-08.
What interventions are being tested in trial NCT05007041?
The interventions under investigation include: FLUAD® Quadrivalent (BIOLOGICAL), Fluzone® High-Dose Quadrivalent (BIOLOGICAL), SHINGRIX® (BIOLOGICAL).
Who is sponsoring clinical trial NCT05007041?
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 NCT05007041's enrollment target sits among peer trials
267 320th of 2000 higher than 1,681 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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