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Safety and Immunogenicity Study of H3N2 M2SR Monovalent Influenza Vaccine in Healthy Volunteers

NCT02822105 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-08-10

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

the H3N2 M2SR monovalent influenza vaccine

The H3N2 Bris10 M2SR influenza vaccine candidate (Bris10 M2SR) is formulated to contain different levels of an M2-deleted non-replicating influenza virus expressing the HA and NA genes of influenza strain A/Brisbane/10/2007.

OTHER

Placebo

saline

Sponsors & Collaborators

  • FluGen Inc

    lead INDUSTRY

Principal Investigators

  • Renee Herber · FluGen Inc

  • Carlos Fierro, MD · Johnson County Clin Trials

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-04-30
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02822105 on ClinicalTrials.gov