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Vaccine

Group 3 for Influenza

Phase 1
Waitlist Available
Led By Joanne Langley, M.D.
Research Sponsored by Folia Biotech Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Good general health status, as determined by history and physical examination no greater than 30 days prior to administration of the first test article.
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of Diary Cards, return for follow-up visits).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This is a phase 1, research study is looking at the safety and acceptability of a new vaccine adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral) to test the safety and effectiveness of new vaccines and medications on healthy volunteers. The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In the first six months/180 days of the study participants will have visits to the study site during which safety and immunogenicity outcomes will be measured. From Day 181 to Year 3, participants will be contacted by telephone or email to collect information on any adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety
Secondary outcome measures
Hematologic Agents
Immune responses
Immunogenicity
+4 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Group 6Experimental Treatment2 Interventions
Single dose of the test article (0.125 mL of TIV with 4x PAL i.e., 240 μg).
Group II: Group 5Experimental Treatment2 Interventions
Single dose of the test article (0.25 mL of TIV which is 7.5 μg of each influenza strain with 4x PAL (i.e., 240 μg).
Group III: Group 4Experimental Treatment2 Interventions
Single dose of the test article (0.25 mL of TIV which is 7.5 μg of each influenza strain with 2x PAL (i.e., 120 μg).
Group IV: Group 3Experimental Treatment2 Interventions
Single dose of the test article (0.25 mL TIV, which is 7.5 μg of each influenza strain with 1x PAL, i.e. 60 μg).
Group V: Group 2Experimental Treatment2 Interventions
Single dose of the test article (0.25 mL TIV, which is 7.5 μg of each influenza strain with 0.5x PAL, i.e. 30 μg).
Group VI: Group 1Active Control1 Intervention
Single dose of control vaccine (a single dose of 0.5 mL TIV).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Haemagglutinin-strain B
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Folia Biotech Inc.Lead Sponsor
Joanne Langley, M.D.Principal InvestigatorCanadian Center for Vaccinology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025