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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: Completed Phase 1 study of Influenza a, sponsored by FluGen.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Record adverse events following one and two administrations of the Bris10 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Bris10 M2SR or placebo administration.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2019-09-03 |
| Est. Completion | 2020-07-01 |
| Phase | Phase 1 |
What the finished NCT03999554 record still lists
NCT03999554 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 2,734-participant average among 10 other Influenza a trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03999554's enrollment target sits among peer trials
206 8th of 10 higher than 3 of 10 other Influenza a trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza a trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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