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Further Investigation of an Intramuscular Influenza Vaccine (Multimeric-001)

NCT01146119 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-07-31

No results posted yet for this study

Summary

This is a multi-center, randomized, two stage, double-blind, placebo-controlled administration study comprising 200 healthy participants.

Conditions

Interventions

BIOLOGICAL

Multimeric-001, 500 mcg

Adjuvanted Multimeric-001 was administered twice with an interval of 19-23 days.

BIOLOGICAL

Adjuvanted PBS

Adjuvanted PBS was administered twice with an interval of 19-23 days.

BIOLOGICAL

PBS and TIV 15%

PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 15% dose of commercial seasonal trivalent vaccine (season 2011) was administered.

BIOLOGICAL

PBS and TIV 50%

PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 50% dose of commercial seasonal trivalent vaccine (season 2011) was administered.

Sponsors & Collaborators

  • BiondVax Pharmaceuticals ltd.

    lead INDUSTRY

Principal Investigators

  • Jacob Atsmon, MD · Clinical Research Center, Tel-Aviv Sourasky Medical Center

  • Yosef Caraco, Phd · Clinical Research Center, Hadassah Medical Center, Jerusalem

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-05-31
Completion
2011-06-30

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 NCT01146119 on ClinicalTrials.gov