MedTrace Logo

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

NCT01010737 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-07-31

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • BiondVax Pharmaceuticals ltd.

    lead INDUSTRY

Principal Investigators

  • Jacob Atsmon, MD · CRC, Sourascky MC, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01010737 on ClinicalTrials.gov