drugset / Trial / NCT02188810

Safety and Reactogenicity of a PAL Combined With Seasonal Flu Vaccine in Healthy Adults

NCT02188810 ↗

Phase 1 Unknown 48 enrolled Folia Biotech Inc.
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2014-04
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject PAL Other / unclassified 30 ug Intramuscular
Subject PAL Other / unclassified 60 ug Intramuscular
Subject PAL Other / unclassified 120 ug Intramuscular
Subject PAL Other / unclassified 240 ug Intramuscular
Subject TIV Vaccine 0.125 ml Intramuscular
Subject TIV Vaccine 0.25 ml Intramuscular
Subject TIV Vaccine 0.5 ml Intramuscular

Indications