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NCT05163847 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults
A Phase 1 study, sponsored by FluGen.
- Completed
- Registry status
- Phase 1
- Development phase
- 303
- Enrollment target
NCT05163847: Completed Phase 1 study, sponsored by FluGen.
NCT05163847 is a Phase 1 study that has completed, run by FluGen. The registered enrollment target is 303 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (405% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05163847, a Phase 1 study, has completed, sponsored by FluGen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 303 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV) delivered IM to a healthy adult population age 65 to 85 years at time of enrollment.
Primary Outcome
The number and percentage of subjects who experience solicited local and systemic reactions during the 7 days after vaccine administration of M2SR administration alone or with IIV
Interventions
- OTHER IN Placebo
- OTHER IM Placebo
- BIOLOGICAL Cam2020 M2SR H3N2 influenza vaccine
- BIOLOGICAL Fluzone HD IIV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2022-11-03 |
| Phase | Phase 1 |
What the finished NCT05163847 record still lists
NCT05163847 is an interventional study that assigns participants to a tested intervention. The registered 303 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 (405% higher).
The record links to 0 conditions, and to 4 interventions - of which IN Placebo is the first listed.
NCT05163847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05163847 about?
NCT05163847 is a clinical study titled "Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults". This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV) delivered IM to a healthy adult populat...
What is the current status of trial NCT05163847?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 303 participants. The study started on 2022-06-14. Estimated completion is 2022-11-03.
What interventions are being tested in trial NCT05163847?
The interventions under investigation include: IN Placebo (OTHER), IM Placebo (OTHER), Cam2020 M2SR H3N2 influenza vaccine (BIOLOGICAL), Fluzone HD IIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT05163847?
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 NCT05163847's enrollment target sits among peer trials
303 124th of 2000 higher than 1,877 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
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