Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04785794 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old
A Phase 1 study, sponsored by FluGen.
- Completed
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
NCT04785794: Completed Phase 1 study, sponsored by FluGen.
NCT04785794 is a Phase 1 study that has completed, run by FluGen. The registered enrollment target is 122 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04785794, a Phase 1 study, has completed, sponsored by FluGen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years.
Primary Outcome
The number and percentage of study participants who experience local (at the dose administration site) and systemic (throughout the body) reactions during the 7 days after administration of investigational M2SR vaccine or placebo. Solicited and unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding Medical Dictionary for Regulatory Activities (MedDRA) terminology of the sign or symptom or combined using the appr
Interventions
- OTHER Placebo
- BIOLOGICAL Sing2016 M2SR H3N2 influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 1 |
What the finished NCT04785794 record still lists
NCT04785794 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04785794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04785794 about?
NCT04785794 is a clinical study titled "Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old". This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years.
What is the current status of trial NCT04785794?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2021-06-30. Estimated completion is 2021-11-30.
What interventions are being tested in trial NCT04785794?
The interventions under investigation include: Placebo (OTHER), Sing2016 M2SR H3N2 influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04785794?
This trial is sponsored by FluGen, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04785794's enrollment target sits among peer trials
122 475th of 2000 higher than 1,525 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
- NCT03363373 · 122 participants · Phase 2
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
- NCT03463954 · 122 participants · NA
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
- NCT04503265 · 122 participants · Phase 1
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
- NCT04700527 · 122 participants · Phase 1
The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
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