A Study to Assess the Safety and Immunogenicity of M-001 Influenza Vaccine as a Primer to TIV in Elderly Volunteers

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
InfluenzaHealthy
Interventions
BIOLOGICAL

Two Multimeric-001 administrations followed by TIV

Two administrations of non adjuvanted M-001, 500 mcg followed by TIV at intervals of 19-23 days

BIOLOGICAL

One administration of Multimeric-001 followed by TIV

One administration of non adjuvanted Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days

BIOLOGICAL

One administration of adjuvanted M-001 followed by TIV

One administration of adjuvanted (Aluminum phosphate) Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days

BIOLOGICAL

One administration of placebo followed by TIV

One administration of saline (Placebo)followed by TIV at intervals of 19-23 days (serving as an active comparator)

Trial Locations (1)

Unknown

Hadassah medical center, Jerusalem

Sponsors
All Listed Sponsors
lead

BiondVax Pharmaceuticals ltd.

INDUSTRY