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A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine

NCT03450915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12460

Last updated 2021-10-05

Study results available
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Summary

The pivotal Phase 3 trial plans to enroll a total of approximately 12,460 participants aged 50+ over two years. Participants will be immunized twice with the M-001 universal influenza vaccine candidate or placebo and then followed for up to 2 seasons. The trial will evaluate the number of influenza cases in each group and the severity of illness during the follow up period.

Conditions

Interventions

BIOLOGICAL

M-001

A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.

BIOLOGICAL

Saline

0.9% sodium chloride (NaCl)

Sponsors & Collaborators

  • BiondVax Pharmaceuticals ltd.

    lead INDUSTRY

Principal Investigators

  • Tamar Ben-Yedidia, PhD · BiondVax Pharmaceuticals ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-07-02
Completion
2020-10-23

Countries

  • Poland

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 NCT03450915 on ClinicalTrials.gov