Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Novavax.
NCT04120194 is a Phase 3 study that has completed, run by Novavax. The registered enrollment target is 2,654 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (244% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) expressed as GMFR on Day 28
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 |
What the finished NCT04120194 record still lists
NCT04120194 is an interventional study that assigns participants to a tested intervention. Its 2,654 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (244% higher).
The record links to 0 conditions, and to 2 interventions - of which Fluzone Quadrivalent is the first listed.
NCT04120194 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04120194's enrollment target sits among peer trials
2,654 84th of 2000 higher than 1,917 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06825715 · 2,653 participants · NA
Multilevel Intervention for Precision Oncology
- NCT05471908 · 2,674 participants · NA
Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial
- NCT06455085 · 2,634 participants · NA
RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
- NCT05111925 · 2,690 participants
Pre- and Post-neuromusculoskeletal Injury Risk Evaluation for Return-to-Duty Enhancement
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI