NCT03437304 - Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults | Biotech Hunter

Enrollment

298

Participants

Timeline

Start Date

February 9, 2018

Primary Completion Date

June 30, 2018

Study Completion Date

November 30, 2018

Conditions

Influenza

Interventions

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

Trial Locations (5)

Site 5, Borås

Site 4, Helsingborg

Site 2, Linköping

Site 3, Malmo

Site 1, Uppsala