drugset / Trial / NCT03450915

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

NCT03450915

Phase 3 Completed 12460 enrolled BiondVax Pharmaceuticals ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Multimeric-001 Vaccine 1 mg Intramuscular

Indications