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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: Clinical Trial Phase 2 study, sponsored by Novavax.
NCT03658629 is a Phase 2 study that was terminated before completion, run by Novavax. The registered enrollment target is 1,375 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (934% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection.
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 |
Why NCT03658629 stopped before completion
NCT03658629 is an interventional study that assigns participants to a tested intervention. Its 1,375 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (934% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03658629 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03658629's enrollment target sits among peer trials
1,375 13th of 2000 higher than 1,988 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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