Study to Determine if Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine is Safe, Immunogenic and Efficacious in the Influenza Human Viral Challenge Model

NCT02522754 Phase 1/Phase 2 COMPLETED

A study to compare multiple dosage regimes of a protesomal intranasal vaccine.

Details

Lead sponsor	Hvivo
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	174
Start date	2002-01
Completion	2004-01

Conditions

• Influenza

Interventions

• Placebo Protesomal Vaccine
• Experimental: Protesomal Vaccine 1 x 30 µg
• Experimental: Protesomal Vaccine 2 x 30 µg
• Experimental: Protesomal Vaccine 2 x 15 µg

Primary outcomes

• Reduction in Influenza Like Illness in those with laboratory confirmed influenza — Within the duration of infection, approx 10 days