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NCT03722589 · ClinicalTrials.gov registry record · Phase 4
Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP
A Phase 4 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 4
- Development phase
- 944
- Enrollment target
NCT03722589: Completed Phase 4 study, sponsored by Centers for Disease Control and Prevention.
NCT03722589 is a Phase 4 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 944 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03722589, a Phase 4 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 944 participants
- Enrollment target
Study Summary
This randomized, open-label trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among persons aged 18-64 years. The trial will be conducted at two sites in the United States during two influenza seasons (2018-19 and 2019-20). Stratified enrollment procedures will be used to enroll a mix of participants based on age.
Primary Outcome
MN responses to the cell-grown influenza A/H3N2 vaccine reference viruses for each study season at approximately 28 days post-vaccination, including by assessing SCR in the various vaccine arms defined as the proportion of participants with paired samples that achieved ≥ 4 fold rises comparing post- versus pre-vaccination titers, and post vaccination titers ≥ 40
Interventions
- BIOLOGICAL Fluzone
- BIOLOGICAL Flucelvax
- BIOLOGICAL Flublok
- BIOLOGICAL Fluarix
- BIOLOGICAL Fluzone High-Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 944 participants |
| Start Date | 2018-09-12 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 4 |
What the finished NCT03722589 record still lists
NCT03722589 is an interventional study that assigns participants to a tested intervention. The registered 944 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 (82% higher).
The record links to 0 conditions, and to 5 interventions - of which Fluzone is the first listed.
NCT03722589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03722589 about?
NCT03722589 is a clinical study titled "Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP". This randomized, open-label trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among pers...
What is the current status of trial NCT03722589?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 944 participants. The study started on 2018-09-12. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT03722589?
The interventions under investigation include: Fluzone (BIOLOGICAL), Flucelvax (BIOLOGICAL), Flublok (BIOLOGICAL), Fluarix (BIOLOGICAL), Fluzone High-Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT03722589?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03722589's enrollment target sits among peer trials
944 80th of 2000 higher than 1,921 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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