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NCT03999554 · ClinicalTrials.gov registry record · Phase 1

Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines

A Phase 1 study of Influenza a, sponsored by FluGen.

Completed
Registry status
Phase 1
Development phase
206
Enrollment target
4
Study locations

NCT03999554 is a Phase 1 study of Influenza a that has completed, run by FluGen. The registered enrollment target is 206 participants, below the 2,734-participant average among 10 other Influenza a trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT03999554, a Phase 1 study of Influenza a, has completed, sponsored by FluGen.

COMPLETED
Registry status
Phase 1
Development phase
206 participants
Enrollment target
4
Study locations

Study Summary

This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at higher dosages or in two doses . Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels (low, medium, high), Bris10 M2SR at one dose level (low), or placebo in a 1:1:1:1:1 ratio. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine.

Conditions Studied

Influenza a

Interventions

  • OTHER Placebo
  • BIOLOGICAL LD Sing2016 M2SR H3N2 influenza vaccine
  • BIOLOGICAL MD Sing2016 M2SR H3N2 influenza vaccine
  • BIOLOGICAL HD Sing2016 M2SR H3N2 influenza vaccine
  • BIOLOGICAL LD Bris10 M2SR H3N2 influenza vaccine

Study Locations (4)

Florida

  • RCA - Hollywood

Kansas

  • JCCT - Lenexa

Kentucky

  • AMR Lexington - Lexington

Virginia

  • AMR Norfolk - Norfolk

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2019-09-03
Est. Completion 2020-07-01
Phase Phase 1

Sponsor

FluGen

6 total trials

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What the Registry Record Tells You About NCT03999554

The ClinicalTrials.gov registry entry for NCT03999554 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,734-participant average among 10 other Influenza a trials with a reported enrollment target (92% lower). The listed sponsor is FluGen, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza a appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.

NCT03999554 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, Kansas, Kentucky.

Frequently Asked Questions

What is clinical trial NCT03999554 about?

NCT03999554 is a clinical study titled "Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines". This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogeni...

What is the current status of trial NCT03999554?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 206 participants. The study started on 2019-09-03. Estimated completion is 2020-07-01.

What conditions does trial NCT03999554 study?

This clinical trial studies the following conditions: Influenza a.

What interventions are being tested in trial NCT03999554?

The interventions under investigation include: Placebo (OTHER), LD Sing2016 M2SR H3N2 influenza vaccine (BIOLOGICAL), MD Sing2016 M2SR H3N2 influenza vaccine (BIOLOGICAL), HD Sing2016 M2SR H3N2 influenza vaccine (BIOLOGICAL), LD Bris10 M2SR H3N2 influenza vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT03999554?

This trial is sponsored by FluGen, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03999554 being conducted?

This trial has 4 study locations across Florida, Kansas, Kentucky, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.