M-001 vs Saline: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00417 | 0.00285 | 0.00611 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00465 | 0.00324 | 0.00668 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000482 | -0.0029 | 0.00191 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.897 | 0.529 | 1.52 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.896 | 0.527 | 1.52 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer death from any cause on M-001 than on Saline | 2,080 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | M-001 | Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.~M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses. | 26 | 6,230 | EG000 | ClinicalTrials.gov |
| Group 2 | Saline | Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.~Saline: 0.9% sodium chloride (NaCl) | 29 | 6,230 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, all-cause mortality | ClinicalTrials.gov |
| Time frame | 4 months | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine | ClinicalTrials.gov |
| NCT number | NCT03450915 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Influenza | ClinicalTrials.gov |
| Interventions | M-001, Saline | ClinicalTrials.gov |
| Lead sponsor | BiondVax Pharmaceuticals ltd. | ClinicalTrials.gov |
| Results first posted | 2021-09-13 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03450915?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.