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NCT03598439 · ClinicalTrials.gov registry record · Phase 4
Randomized Influenza Vaccine Evaluation of Immune Response
A Phase 4 study, sponsored by Marshfield Clinic Research Foundation.
- Completed
- Registry status
- Phase 4
- Development phase
- 366
- Enrollment target
NCT03598439: Completed Phase 4 study, sponsored by Marshfield Clinic Research Foundation.
NCT03598439 is a Phase 4 study that has completed, run by Marshfield Clinic Research Foundation. The registered enrollment target is 366 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03598439, a Phase 4 study, has completed, sponsored by Marshfield Clinic Research Foundation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 366 participants
- Enrollment target
Study Summary
Licensed influenza vaccines are manufactured with a variety of technologies. The majority are split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. Two US licensed products do not use egg-adapted viruses: Flucelvax (mammalian cell culture) and FluBlok (recombinant). There is increasing evidence that egg propagation induces virus mutations that impair the immune responses to circulating viruses. However, the impact of egg-propagation on clinical vaccine effectiveness is uncertain, and there is no preferential recommendation for any specific influenza vaccine product or technology. A direct comparison of serologic response to egg based and non-egg based vaccines in adults has not been performed. This randomized trial will compare serologic responses to the egg- and non-egg A(H3N2) vaccine component. The study cohort will be followed for two influenza seasons to evaluate sequential vaccination effects on immune response.
Primary Outcome
geometric mean titers (as measured by microneutralization) to cell-grown A(H3N2) vaccine reference virus
Interventions
- BIOLOGICAL Standard IIV4
- BIOLOGICAL Recombinant
- BIOLOGICAL Cell-culture
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2018-07-30 |
| Est. Completion | 2024-07-09 |
| Phase | Phase 4 |
What the finished NCT03598439 record still lists
NCT03598439 is an interventional study that assigns participants to a tested intervention. The registered 366 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 (29% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard IIV4 is the first listed.
NCT03598439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03598439 about?
NCT03598439 is a clinical study titled "Randomized Influenza Vaccine Evaluation of Immune Response". Licensed influenza vaccines are manufactured with a variety of technologies. The majority are split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. Two US licensed products do not use egg-adapted viruses: Flucelvax (mammalian cell culture) and FluBlok (recombinant). ...
What is the current status of trial NCT03598439?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 366 participants. The study started on 2018-07-30. Estimated completion is 2024-07-09.
What interventions are being tested in trial NCT03598439?
The interventions under investigation include: Standard IIV4 (BIOLOGICAL), Recombinant (BIOLOGICAL), Cell-culture (BIOLOGICAL).
Who is sponsoring clinical trial NCT03598439?
This trial is sponsored by Marshfield Clinic Research Foundation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03598439's enrollment target sits among peer trials
366 225th of 2000 higher than 1,776 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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