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 range18 Years – 49 Years

SexALL

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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

What they're measuring

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)

Trial details

NCT IDNCT02822105

SponsorFluGen Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04

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