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NCT03658629 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
A Phase 2 study, sponsored by Novavax.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1,375
- Enrollment target
NCT03658629 is a Phase 2 study that was terminated before completion, run by Novavax. The registered enrollment target is 1,375 participants.
The verdict
NCT03658629, a Phase 2 study, was terminated before completion, sponsored by Novavax.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1,375 participants
- Enrollment target
Study Summary
A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age. A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.
Interventions
- OTHER Placebo
- BIOLOGICAL Flublok Quadrivalent
- BIOLOGICAL Fluzone HD
- BIOLOGICAL NanoFlu (Quad-NIV)
- OTHER Matrix-M Adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,375 participants |
| Start Date | 2018-09-24 |
| Est. Completion | 2019-04-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03658629
The ClinicalTrials.gov registry entry for NCT03658629 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1,375 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 5 interventions - of which Placebo is the first listed.
NCT03658629 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03658629 about?
NCT03658629 is a clinical study titled "Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults". A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age. A total of approximately 1375 subjects were to be random...
What is the current status of trial NCT03658629?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1,375 participants. The study started on 2018-09-24. Estimated completion is 2019-04-26.
What interventions are being tested in trial NCT03658629?
The interventions under investigation include: Placebo (OTHER), Flublok Quadrivalent (BIOLOGICAL), Fluzone HD (BIOLOGICAL), NanoFlu (Quad-NIV) (BIOLOGICAL), Matrix-M Adjuvant (OTHER).
Who is sponsoring clinical trial NCT03658629?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
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