Safety and Immunogenicity Study of H3N2 M2SR Monovalent Influenza Vaccine in Healthy Volunteers (NCT02822105) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity Study of H3N2 M2SR Monovalent Influenza Vaccine in Healthy Volunteers
United States96 participantsStarted 2016-06
Plain-language summary
The purpose is of this study is to assess the safety and tolerability of three dose levels of H3N2 M2SR influenza vaccine versus placebo delivered intranasally to healthy adult subjects.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Any ≥ Grade 2 abnormality
. Clinically significant Grade 1 abnormality as judged by the Principal Investigator or
. Clinically non-significant Grade 1 abnormality as judged by the Principal Investigator which, upon repeat testing becomes more abnormal
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial that has already been completed, would it be worth asking whether the safety and immunogenicity results have been published, and what they showed about the frequency and severity of side effects in the first 28 days after vaccination?
2The trial was specifically testing an H3N2 M2SR influenza vaccine — can you explain what the M2SR approach means and how it differs from the standard flu shots I might already be eligible for?
3Because this was a Phase 1 study focused primarily on safety rather than proving effectiveness, what would that mean for someone considering this vaccine — is there now a Phase 2 or Phase 3 follow-up trial I should look into instead?
4The trial tracked adverse events all the way through Day 180, which is about six months — does that longer monitoring window suggest there were specific safety concerns being watched for, and is that something relevant to my situation?
5Given that this trial is already completed and no longer enrolling, what are the current standard-of-care options for flu prevention that my doctor would recommend for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and severity of local and systemic adverse events (AEs) through 28 days vaccination and cumulatively through Day 180
Timeframe: from baseline through study completion (Day 180)