M-001 vs Saline: Number of Participants With Culture-confirmed Influenza Incidence
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 | 0.0189 | 0.0157 | 0.0227 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0163 | 0.0133 | 0.0198 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00267 | -0.0021 | 0.00748 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.888 | 1.53 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.886 | 1.54 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on M-001 than on Saline | 374 | 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. | 111 | 5,864 | OG000 | 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) | 96 | 5,905 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Culture-confirmed Influenza Incidence | ClinicalTrials.gov |
| Description | Occurrence of culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness. | ClinicalTrials.gov |
| Time frame | From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year | ClinicalTrials.gov |
| Population | Per protocol population comprises all subjects who received both doses of vaccine or placebo and had at least one contact with study staff after 15 days or more upon second vaccination. | 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.