Trials / Completed
CompletedNCT02998996
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
A Phase I/II, Randomised, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 162 (actual)
- Sponsor
- Eurocine Vaccines AB · Industry
- Sex
- All
- Age
- 18 Years – 39 Years
- Healthy volunteers
- Accepted
Summary
The main purpose of the this study is to evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 15 µg HA/strain and 1% Endocine™ | intranasal administration |
| BIOLOGICAL | 15 µg HA/strain and 2% Endocine™ | intranasal administration |
| BIOLOGICAL | 15 µg HA/strain | intranasal administration |
| BIOLOGICAL | intramuscular comparator | intramuscular administration |
| BIOLOGICAL | intranasal comparator | intranasal administration |
| BIOLOGICAL | Placebo, Saline | intranasal administration |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2016-12-21
- Last updated
- 2019-02-21
- Results posted
- 2019-02-21
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT02998996. Inclusion in this directory is not an endorsement.