CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12,460 enrolled
Drug / intervention
M-001 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03450915
NCT03450915Phase 3Completed
CompareCT.gov

A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years).

BiondVax Pharmaceuticals ltd.·interventional·Posted Mar 1, 2018·Updated Oct 5, 2021

In Brief

A Phase 3 clinical trial evaluating M-001 and Saline for Influenza. Completed, enrolled 12,460 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesPoland
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 1, 2018
Enrollment StartAug 1, 2018
Primary CompletionJul 2, 2020
Study CompletionOct 23, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.3 years ago

Interventions

M-001biological

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

Salinebiological

0.9% sodium chloride (NaCl)