A Randomised, Double-blind, Placebo-controlled Phase IIb Trial to Test FLU-v Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

July 18, 2017

Study Completion Date

July 18, 2017

Conditions
Influenza
Interventions
BIOLOGICAL

FLU-v

Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH

BIOLOGICAL

adjuvanted FLU-v

Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection

BIOLOGICAL

Saline

Subcutaneous injection in the upper arm with 0.5ml of saline

BIOLOGICAL

Adjuvanted placebo

Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection

Trial Locations (1)

8025 AB

Isala, Zwolle

All Listed Sponsors
collaborator

Seventh Framework Programme

OTHER

collaborator

University of Groningen

OTHER

collaborator

University Medical Center Groningen

OTHER

collaborator

Robert Koch Institut

OTHER_GOV

collaborator

Norwegian Institute of Public Health

OTHER_GOV

lead

PepTcell Limited

INDUSTRY

NCT02962908 - A Randomised, Double-blind, Placebo-controlled Phase IIb Trial to Test FLU-v Vaccine | Biotech Hunter | Biotech Hunter