A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Influenza
Interventions
BIOLOGICAL

Multimeric-001 250 mcg

Multimeric-001 (M-001) was administered twice at a dose of 250mcg via the IM route to 10 participants as a primer, followed by TIV boost immunization. in 19-23 days interval between them.

BIOLOGICAL

Adjuvanted Multimeric-001 250mcg

Injection of Multimeric-001 250 mcg with Adjuvant Montonide isa 51 VG, 2 doses with interval of 19-23 days between them

BIOLOGICAL

Placebo

Placebo injected with PBS (Phosphate Buffered Saline), 2 injections with the interval of 19-23 days between them.

BIOLOGICAL

Adjuvant: Montonide isa 51 VG

Injection of Placebo with Adjuvant Montonide isa 51 VG, 2 injections with the interval of 19-23 days between them.

BIOLOGICAL

Multimeric-001 500 mcg

Injection of Multimeric-001 with PBS, 2 injections with the interval of 19-23 days between them.

BIOLOGICAL

Adjuvanted Multimeric-001 500mcg

Injection of Multimeric-001 500 mcg with Adjuvant Montonide isa 51 VG, 2 doses with the interval of 19-23 days between them

BIOLOGICAL

TIV

Injection of the conventional flu vaccine: Vaxigrip to all study participants.

Trial Locations (1)

Unknown

Tasmc Crc, Tel Aviv

Sponsors
All Listed Sponsors
lead

BiondVax Pharmaceuticals ltd.

INDUSTRY