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Vaccine

Vaccine Dose Group 8 mcg dose for Influenza

Phase 2
Waitlist Available
Research Sponsored by VaxInnate Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 90
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either one of two dose levels of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at a 1:1:1 ratio.

Eligible Conditions
  • Influenza

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Seroconversion rates to the 4 components of VAX2012Q
Secondary study objectives
C-reactive protein levels
Immunogenicity of the two dose levels of VAX2012Q and of Fluzone Quadrivalent
Long term safety following vaccination assessed by Clinically significant AEs
+1 more
Other study objectives
Breadth of immunity
Duration of immunity

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Vaccine Dose Group 8 mcg doseExperimental Treatment1 Intervention
VAX2012Q, 8 mcg dose
Group II: Vaccine Dose Group 12 mcg doseExperimental Treatment1 Intervention
VAX2012Q, 12 mcg dose
Group III: ControlActive Control1 Intervention
Fluzone Quadrivalent vaccine

Find a Location

Who is running the clinical trial?

AccelovanceIndustry Sponsor
15 Previous Clinical Trials
3,593 Total Patients Enrolled
VaxInnate CorporationLead Sponsor
11 Previous Clinical Trials
1,704 Total Patients Enrolled
Department of Health and Human ServicesFED
231 Previous Clinical Trials
935,079 Total Patients Enrolled
~43 spots leftby Nov 2025
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