Trials / Completed
CompletedNCT03437304
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults
A Phase I/II, Randomised, Multicentre, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults (Age 50 to 75 Years)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 298 (actual)
- Sponsor
- Eurocine Vaccines AB · Industry
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immunose™ FLU 1% | Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2 |
| BIOLOGICAL | Immunose™ FLU 2%, 200 μl | Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2 |
| BIOLOGICAL | Immunose™ FLU 2%, 300 μl | Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2 |
| BIOLOGICAL | Influenza antigen | Quadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2 |
| DRUG | Placebo | NaCl dosing volume 200 μl, intranasal administration x 2 |
| BIOLOGICAL | i.m comparator | Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1 |
Timeline
- Start date
- 2018-02-09
- Primary completion
- 2018-06-30
- Completion
- 2018-11-30
- First posted
- 2018-02-19
- Last updated
- 2018-12-19
Locations
5 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT03437304. Inclusion in this directory is not an endorsement.