drugset / Trial / NCT01677676
Safety, Tolerability and Immunogenicity of Two Different Formulations of an Influenza A Vaccine (FP-01.1)
Phase 1
Completed
48 enrolled
Immune Targeting Systems Ltd
INCResearch Australia Pty Limited · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This study has been designed to evaluate the safety and immunogenicity of two different formulations of FP-01.1 as well as build on the data set from the first in human study FP-01.1\_CS\_01. It is anticipated that the results of this Phase I study will inform the best formulation of the vaccine to evaluate in efficacy studies.
Timeline
- Start
- 2012-01
- Primary completion
- 2012-05
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | FP-01.1 | Peptide | 150 ug | Intramuscular |
| Comparator | FP-01.1 | Peptide | 250 ug | Intramuscular |
| Comparator | FP-01.1-Adjuvant | Vaccine | 150 ug | Intramuscular |
| Comparator | FP-01.1-Adjuvant | Vaccine | 250 ug | Intramuscular |
| Comparator | FP-01.1-Adjuvant | Vaccine | 10.8 mg | Intramuscular |
| Comparator | FP-01.1-Adjuvant | Vaccine | 18 mg | Intramuscular |