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NCT04120194 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
A Phase 3 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,654
- Enrollment target
NCT04120194 is a Phase 3 study that has completed, run by Novavax. The registered enrollment target is 2,654 participants.
The verdict
NCT04120194, a Phase 3 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,654 participants
- Enrollment target
Study Summary
A Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age. Both vaccines were formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season. 2654 subjects were enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator. Subjects were followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera. This trial was conducted in the United States at approximately 19 clinical sites.
Interventions
- BIOLOGICAL Fluzone Quadrivalent
- BIOLOGICAL NanoFlu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,654 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2020-12-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04120194
The ClinicalTrials.gov registry entry for NCT04120194 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,654 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fluzone Quadrivalent is the first listed.
NCT04120194 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04120194 about?
NCT04120194 is a clinical study titled "Phase 3 Pivotal Trial of NanoFlu™ in Older Adults". A Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age. B...
What is the current status of trial NCT04120194?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,654 participants. The study started on 2019-10-14. Estimated completion is 2020-12-13.
What interventions are being tested in trial NCT04120194?
The interventions under investigation include: Fluzone Quadrivalent (BIOLOGICAL), NanoFlu (BIOLOGICAL).
Who is sponsoring clinical trial NCT04120194?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
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