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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 is a Phase 4 study that has completed, run by Marshfield Clinic Research Foundation. The registered enrollment target is 366 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03598439
The ClinicalTrials.gov registry entry for NCT03598439 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 366 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Marshfield Clinic Research Foundation, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Standard IIV4 is the first listed.
NCT03598439 reports 0 study locations.
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.
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