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Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV

NCT02293317 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-02-23

No results posted yet for this study

Summary

This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001 in thirty six (36) volunteers 50-65 years of age.

All subjects will receive an intramuscular (IM) injection, in each one of three visits, with a 21±2 days interval between treatments.

Conditions

Interventions

BIOLOGICAL

M-001

A recombinant epitope based universal vaccine against seasonal and pandemic influenza

DRUG

TIV

HA based seasonal influenza vaccine, for 2014/15 seson

OTHER

Saline

Placebo

Sponsors & Collaborators

  • BiondVax Pharmaceuticals ltd.

    lead INDUSTRY

Principal Investigators

  • Tamar Ben Yedidia, PhD · BiondVax Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-03-31
Completion
2015-06-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

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 NCT02293317 on ClinicalTrials.gov