Who is sponsoring NCT01010737?

NCT01010737 is sponsored by BiondVax Pharmaceuticals ltd..

What drugs are being tested in NCT01010737?

Interventions: Multimeric-001 250 mcg, Adjuvanted Multimeric-001 250mcg, Placebo, Adjuvant: Montonide isa 51 VG, Multimeric-001 500 mcg, Adjuvanted Multimeric-001 500mcg, TIV.

What is the status of NCT01010737?

NCT01010737 is currently COMPLETED.

Last reviewed 2012-07-30 · How we verify

A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose, Safety and Priming Potential Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers

NCT01010737 Phase 1/Phase 2 COMPLETED

This is a phase I/II, randomized, single-blind, placebo-controlled escalating double-dose study of the safety and priming potential of an intramuscular Influenza vaccine (Multimeric-001) injected to elderly volunteers.

Details

Lead sponsor	BiondVax Pharmaceuticals ltd.
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	60
Start date	2009-09
Completion	2010-03

Conditions

Influenza

Interventions

Multimeric-001 250 mcg
Adjuvanted Multimeric-001 250mcg
Placebo
Adjuvant: Montonide isa 51 VG
Multimeric-001 500 mcg
Adjuvanted Multimeric-001 500mcg
TIV

Primary outcomes

To assess the safety, local and systemic tolerability and reactogenicity of Multimeric-001 vaccine when administered intramuscularly twice to elderly male and female subjects, using chemistry, CBC, fibrinogen, and urinalysis measurements. — From day 0 until termination visit
The Multimeric-001 vaccine exhibits a positive safety profile. The number of subjects reporting adverse events (AEs) after treatment with active vaccines was similar to respective placebo cohorts. Overall AE frequencies for each active group were similar to those of placebo counterparts.

Countries

Israel