Comparison · NCT03880474-deaths
MVA-NP+M1 Group vs Saline Placebo Group: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. MVA-NP+M1 Group vs Saline Placebo Group: deaths from any cause. Trial comparisons, record NCT03880474-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03880474-deaths
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.00355 | wilson | |
| Risk in group 2 | 0.00093 | 0.000164 | 0.00525 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00093 | -0.00525 | 0.00271 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer death from any cause on MVA-NP+M1 Group than on Saline Placebo Group | 1,075 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | MVA-NP+M1 Group | Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected. | 0 | 1,077 | EG000 |
| Group 2 | Saline Placebo Group | Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected. | 1 | 1,075 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Unsolicited non-serious adverse events will be collected for 28 days post-vaccination. Hospitalisations, other serious adverse events and or adverse events of special interest will be collected for the duration of the influenza season. Solicited adverse events, including solicited local injection site reactions (ISR) and solicited systemic reactions, will be collected for 7 days post-vaccination. These will be recorded daily in the eDiary for all participants.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
- NCT number
- NCT03880474
- Phases
- PHASE2
- Conditions
- Influenza
- Interventions
- MVA-NP+M1, Saline
- Lead sponsor
- Barinthus Biotherapeutics
- Results first posted
- 2021-04-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03880474?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- 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
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone 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.
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