drugset / Trial / NCT03437304
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults
RandomizedParallel-groupSingle-blindPrevention
Summary
This is a Phase I/II, randomised, multicentre, partially double-blind (group 1, 2, 4 and 5), parallel-group study designed to primarily evaluate the safety, tolerability and immune response in older adults (age 50 to 75 years) following Immunose™ FLU vaccination at 5 sites in Sweden. A total of 300 subjects will be randomised to 1 of 7 treatment groups. The hypothesis is that Immunose™ FLU is safe and tolerable and will increase the influenza-specific mucosal immune response in older adults.
Timeline
- Start
- 2018-02-09
- Primary completion
- 2018-06-30
- Completion
- 2018-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immunose FLU | Vaccine | 30 ug | Intranasal |
| Subject | Immunose FLU | Vaccine | 0.2 ml | Intranasal |
| Subject | Immunose FLU | Vaccine | 0.3 ml | Intranasal |
| Subject | Immunose FLU | Vaccine | 1 % | Intranasal |
| Subject | Immunose FLU | Vaccine | 2 % | Intranasal |
| Subject | Influenza antigen | Vaccine | 30 ug | Intranasal |
| Subject | Influenza antigen | Vaccine | 0.2 ml | Intranasal |
| Subject | i.m comparator | Vaccine | 15 ug | Intramuscular |
| Subject | i.m comparator | Vaccine | 0.5 ml | Intramuscular |