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Virus Therapy

Sing2016 M2SR H3N2 influenza vaccine for Flu

Phase 1
Waitlist Available
Research Sponsored by FluGen Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of enrollment through 28 days after receipt of iiv where the iiv was administered an average of 49 days post-ip and with an interval up to 91 days later.
Awards & highlights

Study Summary

This trial is testing a new flu vaccine delivered through the nose to see if it is safe and causes an immune response in adults aged 50-85.

Eligible Conditions
  • Flu

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of enrollment through 28 days after receipt of iiv where the iiv was administered an average of 49 days post-ip and with an interval up to 91 days later.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of enrollment through 28 days after receipt of iiv where the iiv was administered an average of 49 days post-ip and with an interval up to 91 days later. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SAEs Through 28 Days After Licensed IIV Treatment
Treatment Emergent AEs During 28 Days After Experimental Treatment
Treatment Emergent AEs During 7 Days After Experimental Treatment

Side effects data

From 2021 Phase 1 trial • 122 Patients • NCT04785794
10%
cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
M2SR Dose, 50-64 Years of Age
Placebo Dose, 50-64 Years of Age
M2SR Dose, 65-85 Years of Age
Placebo Dose, 65-85 Years of Age

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: M2SR dose, 65-85 years of ageExperimental Treatment1 Intervention
Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older
Group II: M2SR dose, 50-64 years of ageExperimental Treatment1 Intervention
Intranasal M2SR vaccine followed by standard, licensed IIV
Group III: Placebo dose, 50-64 years of agePlacebo Group1 Intervention
Intranasal physiological saline followed by standard, licensed IIV
Group IV: Placebo dose, 65-85 years of agePlacebo Group1 Intervention
Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sing2016 M2SR H3N2 influenza vaccine
2021
Completed Phase 1
~130

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

FluGen IncLead Sponsor
5 Previous Clinical Trials
641 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,347 Total Patients Enrolled
Pamuk BilselStudy DirectorFluGen Inc
2 Previous Clinical Trials
509 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old
2021. "Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04785794.
~33 spots leftby Apr 2025
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