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Virus Therapy
Cam2020 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
Subjects must be willing and able to provide written informed consent to participate; a legally authorized representative (LAR) may not be used.
Males and nonchildbearing potential females 65-85 years of age at the time of consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 29
Awards & highlights
Study Summary
This trial is testing an influenza vaccine delivered IN (nasally) alone or concomitantly with IIV (inactivated influenza vaccine delivered IM (intramuscularly)). The trial is testing for safety and immunogenicity in adults aged 65-85.
Eligible Conditions
- Flu
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 29
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 experimental treatment
Solicited AEs during 7 days after experimental treatment
Unsolicited AEs during 28 days after experimental treatment
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: M2SR with IIV doseExperimental Treatment2 Interventions
Intranasal M2SR vaccine and intramuscular IIV dose
Group II: M2SR only doseExperimental Treatment2 Interventions
Intranasal M2SR vaccine and intramuscular placebo dose
Group III: IIV only doseActive Control2 Interventions
Intranasal placebo dose and intramuscular IIV dose
Group IV: Placebo only dosePlacebo Group2 Interventions
Intranasal placebo dose and intramuscular placebo dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cam2020 M2SR H3N2 influenza vaccine
2022
Completed Phase 1
~310
Fluzone HD IIV
2022
Completed Phase 1
~310
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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
460 Total Patients Enrolled
United States Department of DefenseFED
856 Previous Clinical Trials
225,292 Total Patients Enrolled
Pamuk BilselStudy DirectorFluGen Inc
2 Previous Clinical Trials
328 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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