drugset / Trial / NCT02188810
Safety and Reactogenicity of a PAL Combined With Seasonal Flu Vaccine in Healthy Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |